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glydo lidocaine hydrochloride 20 mg/mL Jelly — NDC 25021-0673-77 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

glydo lidocaine hydrochloride 20 mg/mL Jelly — NDC 25021-673-77 (Billing 25021-0673-77)

by Sagent Pharmaceuticals · 10 SYRINGE in 1 CARTON / 11 mL in 1 SYRINGE

This is a package of glydo lidocaine hydrochloride 20 mg/mL Jelly from Sagent Pharmaceuticals, marketed since Sep 2014 and currently FDA-listed; retail pharmacies pay about $0.5162 per mL (NADAC).

NDC 25021-0673-77
🏷️ FDA NDC (as labeled) 25021-673-77 billing pads the product segment with a zero
This package
Contains11 mL in 1 syringe Cost per mL$0.5162 NADAC Per package$56.78 / 110 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.70/unit — full pricing hub ↓
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 25021-673-77 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
25021 labeler · 673 product · 77 package
Package marketed since
Sep 15, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 2502167377 5
Medicaid fills, this package
3,389 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Lidocaine Hydrochloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 16, 2026 — Presence of Particulate Matter: Hair was found in products (Fresenius Kabi USA, LLC) · FDA recall D-0726-2026
Class II · Jun 8, 2026 — Lack of Assurance of Sterility (Asclemed USA Inc.) · FDA recall D-0658-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0529-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0532-2026
Class II · Nov 30, 2021 — Superpotent Drug: Minimally superpotent (Teligent Pharma, Inc.) · FDA recall D-0296-2022
Class I · Nov 30, 2021 — Superpotent Drug (Teligent Pharma, Inc.) · FDA recall D-0295-2022
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 25021-673-77
Product NDC 25021-673
11-digit billing NDC 25021067377
NCPDP billing unit ML — per mL (volume)
RxCUI 1011852, 1549447
UNII EC2CNF7XFP
Application # ANDA201094
SPL Set ID 65760723-75cd-472c-96e1-7d05f95b4686
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-09-15
Route TOPICAL
Dosage form JELLY
Substance LIDOCAINE HYDROCHLORIDE ANHYDROUS
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 9085006010E420
GPI class Glydo
GCN Seq No 038861
GCN 09614
HICL code 001478
Ingredient (HICL) Lidocaine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H0
Therapeutic class — intermediate (HIC2) Act On Non-Autonomic Nervous System
HIC3 code H0A
Therapeutic class — specific (HIC3) Local Anesthetics
AHFS code 52:16.00.00
AHFS class Local Anesthetics (Eent)
FDB label name GLYDO 2% JELLY SYRINGE
FDB brand name Glydo
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 038861
  • GCN: 09614
  • GPI-14 (Medi-Span): 9085006010E420
  • HICL (First Databank): 001478
  • AHFS class code: 52:16.00.00
  • RxCUI (RxNorm): 1011852
Why two NDCs? The FDA registers this code as 25021-673-77 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 25021-0673-77. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name GLYDO 2% JELLY SYRINGE Ingredient Lidocaine Hcl
📗 Our plain-language guide HelloPharmacist
  • Lidocaine numbs the area where it is used. Clinicians inject it for procedures. Skin products are used for pain, itching, minor burns, insect bites, hemorrhoid discomfort, and in s...
  • Clean and dry the skin first, then apply as your product’s directions say. Wash your hands afterward. Don’t exceed the number of uses on the label. Ask a doctor before using a prod...
  • No. Heat can increase how much lidocaine your body absorbs. Don’t bandage tightly either. Also avoid using other topical pain products at the same time.
  • Can I use a heating pad with a lidocaine patch?
📖 Read our full Lidocaine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.516 $56.78 / 110 ml
Medicaid paysCMS SDUD · 12 mo $1.70 $187.20 / 110 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.519 $0.502
▲ Up 2% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
25021-0673-76 25021-673-76 Main listing 10 SYRINGE in 1 CARTON / 6 mL in 1 SYRINGE $0.8977 / mL $53.86 2014-09-15 — Active
25021-0673-77 You're viewing this 10 SYRINGE in 1 CARTON / 11 mL in 1 SYRINGE $0.5162 / mL $56.79 2014-09-15 — Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.5162 NADAC).

This pack accounts for about 35% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 syringe in 1 carton / 11 ml in 1 syringe.
What NDC number is used to bill for this package of glydo lidocaine hydrochloride 20 mg/mL Jelly?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
glydo 20 mg/mLthis 25021-0673-77 Sagent 10 syringes $0.516 AT Availability likely —
Lidocaine Hydrochloride 20 mg/mL 76329-3013-05 International 25 vials $0.704 AT Availability likely +36%
Lidocaine Hydrochloride 20 mg/mL 76329-3011-05 International 25 vials $1.167 AT Availability likely +126%
Lidocaine Hydrochloride 20 mg/mL 76329-3012-05 International 25 vials $1.167 AT Availability likely +126%
Lidocaine Hydrochloride 20 mg/mL 00404-9898-10 Henry 1 vial — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 00404-9899-20 Henry 1 vial — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 00404-9900-05 Henry 1 vial — AT FDA listed —
First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel 20 mg/g 00924-5004-00 Acme 3.5 g — — FDA listed —
First Aid Only Burn 20 mg/g 00924-5010-00 Acme 3.5 g — — FDA listed —
Burn 20 mg/g 43473-0048-01 Nantong 9 g — — FDA listed —
PO First Aid Series BURN 2 g/100g 43473-0062-01 Nantong 9 g — — FDA listed —
JJ Care BURN 2 g/100g 43473-0069-01 Nantong 9 g — — FDA listed —
Lightning X Burn Relief Gel 2 g/100g 43473-0121-01 Nantong 9 g — — FDA listed —
Medi-First Burn 20 mg/g 47682-0477-69 Unifirst 6 packets — — FDA listed —
Lidocaine Hci 20 mg/mL 51662-1389-01 HF 5 ml — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 51662-1551-03 HF 25 pouches — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 51662-1552-03 HF 25 pouches — AT FDA listed —
Burn Ease 2 g/100g 58228-2010-01 ProStat 25 packets — — FDA listed —
PROSTAT FIRST AID Burn Ease, 0.9g 2 g/100g 58228-2012-01 ProStat 25 packets — — FDA listed —
Burn Ease Cooling 2 g/100g 58228-2893-05 ProStat 2000 packets — — FDA listed —
Burn Ease 2 g/100g 58228-3831-02 ProStat 20 packets — — FDA listed —
Burn Ease 2 g/100g 58228-3832-02 ProStat 6 packets — — FDA listed —
PS-3866 Burn Ease, 0.9g 2 g/100g 58228-3866-01 ProStat 10 packets — — FDA listed —
PROSTAT FIRST AID Burn Ease, 0.9g 2 g/100g 58228-3867-01 ProStat 10 packets — — FDA listed —
Burn Ease, 3.5g 2 g/100g 58228-3883-01 ProStat 2000 packets — — FDA listed —
PS-3885 Burn Ease, 3.5g 2 g/100g 58228-3885-01 ProStat 6 packets — — FDA listed —
Burn Ease 2 g/100g 58228-6210-01 Front 25 packets — — FDA listed —
FL Burn Ease, 0.9g 2 g/100g 58228-6212-01 ProStat 25 packets — — FDA listed —
Burn Ease 3.5g 2 g/100g 58228-6231-01 Front 20 packets — — FDA listed —
Burn Ease 3.5g 2 g/100g 58228-6232-01 Front 6 packets — — FDA listed —
Burn Ease 3.5g 2 g/100g 58228-6283-01 Front 2000 packets — — FDA listed —
Lidoease 2% 20 mg/g 59088-0221-03 PureTek 28.35 g — — FDA listed —
Burn Jel 2 g/100mL 59898-0200-11 Water-Jel 24 bottles — — FDA listed —
Lidocaine Hydrochloride 20 mg/g 61010-5000-00 Safetec 3.3 g — — FDA listed —
Aloe Ice Sunburn Relief 2 g/100mL 61477-0101-11 Aloe 60 ml — — FDA listed —
Regenecare Ha 20 mg/g 66977-0107-03 MPM 85 g — — FDA listed —
XeroBurn Burn Gel 2 g/100g 67777-0129-02 Dynarex 1728 packets — — FDA listed —
Burn Gel .02 g/g 69396-0106-09 Trifecta 144 packets — — FDA listed —
Redicare Burn Gel 20 mg/g 71105-0500-02 Redicare 15 packets — — FDA listed —
Jelcaine Sterile 20 mg/mL 71351-0025-30 Brookfield 30 ml — — FDA listed —
Lidocaine 20 mg/mL 72485-0611-10 ARMAS 1 tube — AT FDA listed —
Lidocaine Hydrochloride 20 mg/mL 76329-3015-05 International 25 vials — AT FDA listed —
Burn 20 mg/g 82942-1001-01 J&A 9 g — — FDA listed —
Lidomax 20 mg/g 85477-0304-07 Oncora 85 g — — FDA listed —
Collavera 20 mg/g 85477-0305-07 Oncora 28.33 g — — FDA listed —
Lidocaine Hydrochloride 2% 2 g/100g 87236-0015-35 Aldermed 25 packets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2014
On the market since
Sep 2014
📍
2026
Currently FDA-listed
12 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Lidocaine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSagent Pharmaceuticals
Application holderSAGENT PHARMACEUTICALS INC
FDA applicationANDA201094 (ANDA)
Labeler code25021
First marketedSep 2014
Product typeHuman Prescription Drug
Portfolio209 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 101 words ▾

1 INDICATIONS AND USAGE GLYDO (lidocaine HCl jelly) 2% is an amide local anesthetic indicated: for prevention and control of pain in procedures involving the male and female urethra for topical treatment of painful urethritis as an anesthetic lubricant for oral and nasal endotracheal intubation GLYDO (lidocaine HCl jelly) 2% contains lidocaine, an amide local anesthetic, and is indicated in adult patients: for prevention and control of pain in procedures involving the male and female urethra ( 1 ) for topical treatment of painful urethritis ( 1 ) as an anesthetic lubricant for oral and nasal endotracheal intubation ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The toxic effects of local anesthetics are additive. When using this product concomitantly with other lidocaine-containing products, consider the total dose of lidocaine and monitor patients for cardiovascular and respiratory vital signs. ( 2.1 ) For surface anesthesia of male adult urethra: 15 mL (300 mg lidocaine HCl) followed by additional 15 mL if needed ( 2.2 ) For surface anesthesia of female adult urethra: 3 mL to 5 mL (60 mg to 100 mg lidocaine HCl) ( 2.3 ) For lubrication for endotracheal intubation: sufficient amount to coat the external surface of endotracheal tube ( 2.4 ) For pediatric patients: Not more than 4.5 mg/kg body weight of lidocaine HCl ( 2.5 )

2.1Important Dosage and Administration Information Administration Precautions The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with GLYDO (lidocaine HCl jelly) 2% [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 ), Overdosage ( 10 )] . The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia.

The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. Although the incidence of adverse effects with GLYDO (lidocaine HCl jelly) 2% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

No more than 600 mg of lidocaine HCl should be given in any 12 hour period.

2.2For Surface Anesthesia of the Male Adult Urethra Slowly instill approximately 15 mL (300 mg of lidocaine HCl) into the urethra. Apply a penile clamp for several minutes at the corona. An additional dose of not more than 15 mL (300 mg) can be instilled if needed.

Prior to sounding or cystoscopy, a penile clamp should be applied for 5 to 10 minutes to obtain adequate anesthesia. A total dose of 30 mL (600 mg) is usually required to fill and dilate the male urethra. Prior to catheterization, 5 mL to 10 mL (100 mg to 200 mg) are recommended for lubrication.

2.3For Surface Anesthesia of the Female Adult Urethra Slowly instill approximately 3 mL to 5 mL (60 mg to 100 mg of lidocaine HCl) into the urethra. In order to obtain adequate anesthesia, wait for several minutes prior to performing urological procedures. If desired, some jelly may be deposited on a cotton swab and introduced into the urethra.

2.4Lubrication for Endotracheal Intubation Apply a sufficient amount of jelly to coat the external surface of the endotracheal tube shortly before use. Care should be taken to avoid introducing the product into the lumen of the tube. Do not use the jelly to lubricate endotracheal stylettes.

(see WARNINGS and ADVERSE REACTIONS concerning rare reports of inner lumen occlusion). It is also recommended that use of endotracheal tubes with dried jelly on the external surface be avoided for lack of lubricating effect.

2.5Dosing for Pediatric Patients A maximum dose of GLYDO (lidocaine HCl jelly) 2% for children varies based on age and weight. The maximum dose should not exceed 4.5 mg/kg of body weight. For children over 3 years of age, the maximum dose is determined by the child's age and weight.

For example, in a child of 5 years weighing approximately 23 kg, the dose of lidocaine hydrochloride should not exceed approximately 75 mg to 100 mg (3.3 mg/kg to 4.4 mg/kg). The lowest effective dose should be used.

💊 Dosage Forms and Strengths 46 words ▾

3 DOSAGE FORMS AND STRENGTHS GLYDO (lidocaine HCl jelly, USP) 2% in: 120 mg per 6 mL Prefilled Syringe 220 mg per 11 mL Prefilled Syringe 120 mg per 6 mL Prefilled Syringe ( 3 ) 220 mg per 11 mL Prefilled Syringe ( 3 )

⛔ Contraindications 122 words ▾

4 CONTRAINDICATIONS Known hypersensitivity to any local anesthetic agent of the amide-type or to other components of GLYDO 2% Jelly ( 4.1 ) Infected and/or Severely Traumatized Mucosa ( 4.2 ) Severe shock or heart block ( 4.3 )

4.1Hypersensitivity GLYDO 2% Jelly is contraindicated in patients with a known history of hypersensitivity to lidocaine or to any local anesthetics of the amide type or to other components of GLYDO 2% Jelly.

4.2Use on Infected and/or Severely Traumatized Mucosa GLYDO 2% Jelly should not be used on infected and/or severely traumatized mucosa in the area of application.

4.3Use in Severe Shock or Heart Block GLYDO 2% Jelly should not be used in patients with severe shock or heart block.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Dose-Related Toxicity : follow dosing instructions carefully. ( 5.1 ) Methemoglobinemia : Cases have been reported in association with local anesthetics use. See full prescribing information for more details on managing these risks.

( 5.2 ) Familial Malignant Hyperthermia : Monitoring of patients is recommended ( 5.3 ) Endotracheal Tube Occlusion : Avoid introduction of jelly into the lumen of the endotracheal tube ( 5.4 ) Risk of Aspiration and Biting Trauma with Oral Use : Food and chewing gum should not be taken while the mouth or throat area is anesthetized ( 5.7 )

5.1Dose-Related Toxicity The safety and effectiveness of GLYDO 2% Jelly depends on proper dosage, correct technique, adequate precautions, and readiness for emergencies [see Adverse Reactions ( 6 )]. Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be performed after application of GLYDO 2% Jelly. Possible early warning signs of central nervous system (CNS) toxicity are restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, or drowsiness.

Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest, and, possibly, death. Use the lowest dosage that results in effective anesthesia to avoid high plasma levels and serious adverse effects. Repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug or its metabolites.

Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical status. Patients and healthcare providers should be instructed to strictly adhere to the recommended dosage and administration guidelines as set forth in this package insert.

The management of serious adverse reactions may require the use of resuscitative equipment, oxygen, and other resuscitative drugs.

5.2Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition [see Drug Interactions ( 7.2 )] . If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.

Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue GLYDO 2% Jelly and any other oxidizing agents.

Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

5.3Familial Malignant Hyperthermia Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial malignant hyperthermia. Since it is not known whether amide-type local anesthetics may trigger this reaction and since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard p… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions associated with the use of GLYDO 2% Jelly were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents.

A major cause of adverse reactions to this group of drugs is excessive plasma levels, which may be due to overdosage or slow metabolic degradation. The most commonly encountered acute adverse reactions that demand immediate counter measures were related to the CNS and the cardiovascular system. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy, or diminished tolerance on the part of the patient.

Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported. There have been rare reports of endotracheal tube occlusion associated with the presence of dried jelly residue in the inner lumen of the tube.

Most common adverse reactions are as follows: Central Nervous System : Lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. ( 6 ) Cardiovascular System : Bradycardia, hypotension, and cardiovascular collapse. ( 6 ) Allergic : Cutaneous lesions, urticaria, edema or anaphylactoid reactions.

( 6 ) Neurologic : Positional headaches, hypotension and backache. ( 6 ) Hematologic : Methemoglobinemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Nervous System Disorders Adverse reactions were characterized by excitation and/or depression of the central nervous system and included lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression, and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiac Disorders High doses have led to high plasma levels and related depression of the myocardium, decreased cardiac output, heartblock, hypotension, bradycardia, and cardiovascular collapse, which may lead to cardiac arrest. Immune System Disorders Allergic reactions are characterized by cutaneous lesions, urticaria, edema, or anaphylactoid reactions.

Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to other components in the formulation.

🔄 Drug Interactions 211 words ▾

7 DRUG INTERACTIONS Local Anesthetics : The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered ( 7.1 ). Drugs Associated with Methemoglobinemia : Patients are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates, nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other drugs ( 7.2 ).

Hepatic Impairment : Consider reduced dosing and increased monitoring for local anesthetic systemic toxicity in patients with hepatic impairment ( 8.6 )

7.1Local Anesthetics The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with GLYDO 2% Jelly cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see Warnings and Precautions ( 5.1 )].

7.2Drugs Associated with Methemoglobinemia Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastics Agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase, Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate, Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric Use : Dose should be reduced commensurate with age, body weight and physical condition ( 8.4 )

8.1Pregnancy Risk Summary Available published data and decades of clinical use with GLYDO 2% Jelly in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Local anesthetics may cause varying degrees of toxicity to the mother and fetus and adverse reactions include alterations of the central nervous system, peripheral vascular tone and cardiac function [see Clinical Considerations ]. There was no evidence of teratogenicity when lidocaine was administered to pregnant rats and rabbits subcutaneously at 0.8 and 0.16 times, respectively, the maximum recommended human dose (MRHD) of 600 mg during the period of organogenesis.

In a published animal reproduction study, pregnant rats administered lidocaine by continuous subcutaneous infusion at 8 times the MRHD during the period of organogenesis resulted in lower fetal body weights [see Data ] . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Maternal adverse reactions During treatment of systemic toxicity, which may appear as maternal hypotension or fetal bradycardia, the parturient should be maintained in the left lateral decubitus position if possible or manual displacement of the uterus off the great vessels be accomplished. Elevating the patient's legs will also help prevent decreases in blood pressure.

The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Labor or delivery Local anesthetics rapidly cross the placenta and can cause varying degrees of maternal, fetal and neonatal toxicity [see Clinical Pharmacology ( 12.3 )] . The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration.

Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function. However, dosage recommendations for local anesthesia are much lower than dosage recommendations for other major blocks. Data Animal Data Reproduction studies for lidocaine have been performed in both rats and rabbits.

There was no evidence of harm to the fetus when pregnant rats were given subcutaneous doses of up to 50 mg/kg lidocaine (approximately 0.8 times the MRHD of 600 mg based on body surface area (BSA) comparison) during the period of organogenesis. In addition, there was no evidence of harm to the fetus when pregnant rabbits were given a subcutaneous dose of 5 mg/kg (approximately 0.16 times the MRHD based on BSA comparison) during the period of organogenesis. Treatment of pregnant rabbits with 25 mg/kg (approximately 0.8 times the MRHD based on BSA comparison) produced evidence of maternal toxicity and evidence of delayed fetal development, including a non-significant decrease in fetal weight (7%) and an increase in minor skeletal anomalies (skull and sternebral defect, reduced ossification of the phalanges).

The effect of lidocaine on post-natal development was examined in rats by treating pregnant female rats daily subcutaneously at doses of 2, 10, and 50 mg/kg (approximately 0.03, 0.16, and 0.8 times, respectively, the MRHD based on BSA comparison) from Day 15 of pregnancy and up to 20 days postpartum. No signs of adverse effects were seen either in dams or in the pups up to and including the dose of 10 mg/kg; however, the number of surviving pups was reduced at 50 mg/kg, both at birth and the duration of lactation period, the effe… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available published data and decades of clinical use with GLYDO 2% Jelly in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Local anesthetics may cause varying degrees of toxicity to the mother and fetus and adverse reactions include alterations of the central nervous system, peripheral vascular tone and cardiac function [see Clinical Considerations ]. There was no evidence of teratogenicity when lidocaine was administered to pregnant rats and rabbits subcutaneously at 0.8 and 0.16 times, respectively, the maximum recommended human dose (MRHD) of 600 mg during the period of organogenesis.

In a published animal reproduction study, pregnant rats administered lidocaine by continuous subcutaneous infusion at 8 times the MRHD during the period of organogenesis resulted in lower fetal body weights [see Data ] . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Maternal adverse reactions During treatment of systemic toxicity, which may appear as maternal hypotension or fetal bradycardia, the parturient should be maintained in the left lateral decubitus position if possible or manual displacement of the uterus off the great vessels be accomplished. Elevating the patient's legs will also help prevent decreases in blood pressure.

The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Labor or delivery Local anesthetics rapidly cross the placenta and can cause varying degrees of maternal, fetal and neonatal toxicity [see Clinical Pharmacology ( 12.3 )] . The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration.

Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function. However, dosage recommendations for local anesthesia are much lower than dosage recommendations for other major blocks. Data Animal Data Reproduction studies for lidocaine have been performed in both rats and rabbits.

There was no evidence of harm to the fetus when pregnant rats were given subcutaneous doses of up to 50 mg/kg lidocaine (approximately 0.8 times the MRHD of 600 mg based on body surface area (BSA) comparison) during the period of organogenesis. In addition, there was no evidence of harm to the fetus when pregnant rabbits were given a subcutaneous dose of 5 mg/kg (approximately 0.16 times the MRHD based on BSA comparison) during the period of organogenesis. Treatment of pregnant rabbits with 25 mg/kg (approximately 0.8 times the MRHD based on BSA comparison) produced evidence of maternal toxicity and evidence of delayed fetal development, including a non-significant decrease in fetal weight (7%) and an increase in minor skeletal anomalies (skull and sternebral defect, reduced ossification of the phalanges).

The effect of lidocaine on post-natal development was examined in rats by treating pregnant female rats daily subcutaneously at doses of 2, 10, and 50 mg/kg (approximately 0.03, 0.16, and 0.8 times, respectively, the MRHD based on BSA comparison) from Day 15 of pregnancy and up to 20 days postpartum. No signs of adverse effects were seen either in dams or in the pups up to and including the dose of 10 mg/kg; however, the number of surviving pups was reduced at 50 mg/kg, both at birth and the duration of lactation period, the effect most likely being secondary to maternal toxicity.

No other effects on litter size, litter weight, abnormalities in the pups and phys… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 98 words ▾

8.4Pediatric Use Although the safety and effectiveness of GLYDO 2% Jelly in pediatric patients have not been established, a study of 19 premature neonates (gestational age <33 weeks) found no correlation between the plasma concentration of lidocaine or monoethylglycinexylidide and infant body weight when moderate amounts of lidocaine (i.e. 0.3 mL/kg of lidocaine gel 20 mg/mL) were used for lubricating both intranasal and endotracheal tubes. No neonate had plasma levels of lidocaine above 750 mcg/L.

Dosages in children should be reduced, commensurate with age, body weight, and physical condition [see Dosage and Administration ( 2 )] .

🧓 Geriatric Use 17 words ▾

8.5Geriatric Use Elderly patients should be given reduced doses commensurate with their age and physical condition.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics [see Warnings and Precautions ( 5 ) and Adverse Reactions ( 6 )] . The use of this product concomitantly with other lidocaine products should be done with caution and appropriate patient monitoring. Management of Local Anesthetic Emergencies The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic administration.

At the first sign of change, oxygen should be administered. The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously.

Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e.g., ephedrine).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias, and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask; if difficulty is encountered in the maintenance of a patient airway or if prolonged ventilatory support (assisted or controlled) is indicated.

Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.

12.2Pharmacodynamics The onset of action is 3 to 5 minutes. It is ineffective when applied to intact skin. Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure.

These changes may be attributable to a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine hydrochloride required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 mcg free base per mL.

In the rhesus monkey arterial blood levels of 18 to 21 mcg/mL have been shown to be threshold for convulsive activity.

12.3Pharmacokinetics Absorption Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon concentration and total dose administered, the specific site of application, and duration of exposure. In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug may appear in the circulation because of biotransformation in the liver.

Distribution The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-l-acid glycoprotein.

Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion. Elimination Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation.

N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged.

The primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline. Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics.

The half-life may be prolonged twofold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites.

🧬 Mechanism of Action 27 words ▾

12.1Mechanism of Action Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.

📦 How Supplied / Storage and Handling 89 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING GLYDO ® (lidocaine HCl jelly, USP) 2% is supplied as follows: NDC GLYDO ® (lidocaine HCl jelly, USP) 2% Package Factor (20 mg per mL) 25021-673-76 120 mg per 6 mL Single-Dose Prefilled Syringe 10 syringes per carton 25021-673-77 220 mg per 11 mL Single-Dose Prefilled Syringe 10 syringes per carton Storage Conditions Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Discard unused portion. Sterile, Preservative-free, PVC-free.

The container and container closure are not made with natural rubber latex.

📦 Storage and Handling 33 words ▾

Storage Conditions Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Discard unused portion. Sterile, Preservative-free, PVC-free. The container and container closure are not made with natural rubber latex.

📋 Description 138 words ▾

11 DESCRIPTION GLYDO (lidocaine HCl jelly, USP) 2% is a sterile aqueous product that contains a local anesthetic agent and is administered topically (see INDICATIONS AND USAGE for specific uses). GLYDO (lidocaine HCl jelly, USP) 2% contains lidocaine HCl which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride, the molecular weight is 270.8. The molecular formula is C 14 H 23 ClN 2 O, and has the following structural formula: GLYDO (lidocaine HCl jelly, USP) 2% also contains hypromellose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation.

The unused portion should be discarded after initial use. Composition of GLYDO (lidocaine HCl jelly, USP) 2% 6 mL or 11 mL syringes: Each mL contains 20 mg of lidocaine HCl. The formulation also contains hypromellose, and sodium hydroxide to adjust pH to 6.0 to 7.0.

Figure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION

17.1Allergic-Type Reactions Assess if the patient has had allergic-type reactions to amide-type local anesthetics or to other formulation ingredients [see Contraindications ( 4 ), Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6 )] .

17.2Methemoglobinemia Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue [see Warnings and Precautions ( 5.2 )] .

17.3Risk of Aspiration When topical anesthetics are used in the mouth, the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, food should not be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating.

17.4Risk of Biting Trauma Numbness of the tongue or buccal mucosa may enhance the danger of unintentional biting trauma. Food and chewing gum should not be taken while the mouth or throat area is anesthetized. Brands listed are the trademarks of their respective owners. sagent ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60173 (USA) Mfd. by Klosterfrau Berlin GmbH Made in Germany ©2025 Sagent Pharmaceuticals Revised: May 2025

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Absorption Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon concentration and total dose administered, the specific site of application, and duration of exposure. In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug may appear in the circulation because of biotransformation in the liver.

Distribution The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-l-acid glycoprotein.

Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion. Elimination Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation.

N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged.

The primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline. Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics.

The half-life may be prolonged twofold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites.

🧬 Pharmacodynamics 121 words ▾

12.2Pharmacodynamics The onset of action is 3 to 5 minutes. It is ineffective when applied to intact skin. Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure.

These changes may be attributable to a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine hydrochloride required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 mcg free base per mL.

In the rhesus monkey arterial blood levels of 18 to 21 mcg/mL have been shown to be threshold for convulsive activity.

🧪 Nonclinical Toxicology 189 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals have not been performed to evaluate the carcinogenic potential of lidocaine. Mutagenesis The mutagenic potential of lidocaine has been tested in the Ames Salmonella reverse mutation assay, an in vitro chromosome aberrations assay in human lymphocytes and in an in vivo mouse micronucleus assay. There was no indication of any mutagenic effect in these studies.

Impairment of Fertility The effect of lidocaine on fertility was examined in the rat model. Administration of 30 mg/kg, s.c. (approximately 0.5 times the MRHD based on BSA comparison) to the mating pair did not produce alterations in fertility or general reproductive performance of rats.

There are no studies that examine the effect of lidocaine on sperm parameters. There was no evidence of altered fertility. In a published study, female Sprague-Dawley rats were treated subcutaneously with lidocaine via osmotic pumps starting two weeks prior to mating, and reproductive effects were assessed.

Rats dosed up to 250 mg/kg/day (approximately 4 times the MRHD based on BSA comparison) showed no effects on copulatory rate, pregnancy rate, numbers of corpora lutea, or implantations.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 186 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals have not been performed to evaluate the carcinogenic potential of lidocaine. Mutagenesis The mutagenic potential of lidocaine has been tested in the Ames Salmonella reverse mutation assay, an in vitro chromosome aberrations assay in human lymphocytes and in an in vivo mouse micronucleus assay. There was no indication of any mutagenic effect in these studies.

Impairment of Fertility The effect of lidocaine on fertility was examined in the rat model. Administration of 30 mg/kg, s.c. (approximately 0.5 times the MRHD based on BSA comparison) to the mating pair did not produce alterations in fertility or general reproductive performance of rats.

There are no studies that examine the effect of lidocaine on sperm parameters. There was no evidence of altered fertility. In a published study, female Sprague-Dawley rats were treated subcutaneously with lidocaine via osmotic pumps starting two weeks prior to mating, and reproductive effects were assessed.

Rats dosed up to 250 mg/kg/day (approximately 4 times the MRHD based on BSA comparison) showed no effects on copulatory rate, pregnancy rate, numbers of corpora lutea, or implantations.

📄 Patient Package Insert 188 words ▾

INSTRUCTIONS FOR USE Please note: The blister package contains a sterile syringe. Do not open the blister until ready to use. When ready to use, open the blister and drop the syringe onto a sterile field.

Before removing the tip cap, press in the plunger to remove any resistance that may be present. This helps ensure that the syringe will empty easily and uniformly. Remove the tip cap from the syringe.

The syringe is now ready for use. GLYDO (lidocaine HCl jelly, USP) 2% should be instilled slowly and evenly into the urethra. See the DOSAGE AND ADMINISTRATION section for additional details.

Wait for a few minutes after instillation of GLYDO (lidocaine HCl jelly, USP) 2% for the anesthetic to take full effect. Full anesthetic effect will occur in 5 to 10 minutes after complete instillation. Any gel not used in a single application must be discarded. sagent ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60173 (USA) Mfd. by Klosterfrau Berlin GmbH Made in Germany ©2025 Sagent Pharmaceuticals Revised: May 2025 This “Instructions for Use” has been approved by the U.S.

Food and Drug Administration. Figure Figure Figure

📄 Package Label / Principal Display Panel 96 words ▾

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Syringe Label NDC 25021-673-76 6 mL Single-Dose Prefilled Syringe Rx only glydo ® (lidocaine HCl jelly, USP) 2% 120 mg per 6 mL (20 mg per mL) 6 mL Sterile TOPICAL Anesthetic PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Syringe Label

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Syringe Label NDC 25021-673-77 11 mL Single-Dose Prefilled Syringe Rx only glydo ® (lidocaine HCl jelly, USP) 2% 220 mg per 11 mL (20 mg per mL) 11 mL Sterile TOPICAL Anesthetic PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Syringe Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.4K
Units reimbursed last 4 qtrs
70.8K
Gross reimbursed last 4 qtrs
$120.5K
Avg / prescription
$35.57
Avg / unit
$1.7018
Latest quarter Q1 2026
666Rx
Medicaid pays / mL
$1.7018
gross reimbursed
vs
NADAC / mL
$0.5162
acquisition cost
=
Spread
+$1.1856
+230% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
29% FFS 71% MCO
Fee-for-service · 986 Rx Managed care · 2,403 Rx
State Medicaid map
Alaska: 687 units · 93.7 per 100k residents AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 1,001 units · 88.4 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 1,240 units · 12.4 per 100k residents MI New York: 10,257 units · 52.4 per 100k residents NY Vermont: no data reported VT New Hampshire: 4,322 units · 308 per 100k residents NH Oregon: 418 units · 9.9 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 84 units · 9.1 per 100k residents SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 8,063 units · 68.4 per 100k residents OH Pennsylvania: 6,340 units · 48.9 per 100k residents PA New Jersey: 1,651 units · 17.8 per 100k residents NJ Massachusetts: 1,900 units · 27.1 per 100k residents MA California: 12,486 units · 32.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 3,368 units · 54.4 per 100k residents MO Kentucky: 4,293 units · 94.9 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 9,086 units · 251 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 30 units · 0.4 per 100k residents TN North Carolina: 1,210 units · 11.2 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 3,773 units · 128 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 622 units · 43.3 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.4308
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Hampshire 308 /100k
2 Connecticut 251 /100k
3 Mississippi 128 /100k
4 Kentucky 94.9 /100k
5 Alaska 93.7 /100k
6 Montana 88.4 /100k
7 Ohio 68.4 /100k
8 Missouri 54.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
10 syringes25021-0673-76 6,179 Rx · $221,486
10 syringes this page25021-0673-77 3,389 Rx · $120,537
Drug total (last 4 qtrs): 9,568 Rx · 209,513 units · $342,022 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Glydo — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Glydo. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$97.4K
Claims incl. refills
2.1K
Beneficiaries
1.6K
Spend / beneficiary
$60.97
Spend / claim
$46.84
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for glydo (this brand).

Top reported reactions

Infusion Site Pain729
Nausea492
Infusion Site Erythema456
Headache439
Dyspnoea427
Diarrhoea423
Fatigue370

Reporter sex

6,550 reports

Serious outcomes

Death562
Disabling132
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,459 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.