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Lidocaine 50 mg/g Ointment, 35.44 g — NDC 64380-789-32 (Billing 64380-0789-32)

by Strides Pharma Science Limited · 35.44 g in 1 TUBE

This is a package of 35.44 g of Lidocaine 50 mg/g Ointment from Strides Pharma Science Limited, no longer marketed (first marketed Jan 2019), no longer in the FDA NDC Directory; retail pharmacies pay about $0.1589 per g (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 64380-0789-32
🏷️ FDA NDC (as labeled) 64380-789-32 billing pads the product segment with a zero
This package
Contains35.44 g Cost per g$0.1589 NADAC Per package$5.63 / 35.44 g Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.4025/unit · Part D plans $0.2915/unit — full pricing hub ↓
Main listing for product 64380-789 · Also comes in: 30 g 64380-789-23 50 g 64380-789-33
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Lidocaine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Apr 20, 2023 — Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains. (Bryant Ranch Prepack, Inc.) · FDA recall D-0556-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64380-789-32
Product NDC 64380-789
11-digit billing NDC 64380078932
NCPDP billing unit GM — per gram (weight)
RxCUI 1543069
UNII 98PI200987
Application # ANDA210958
SPL Set ID 8b1efeaa-31b1-4f34-960f-7a920ac07355
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2019-01-01
Route TOPICAL
Dosage form OINTMENT
Substance LIDOCAINE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 90850060004210
GPI class Lidocaine
GCN Seq No 014476
GCN 30750
HICL code 010705
Ingredient (HICL) Lidocaine
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5H
Therapeutic class — specific (HIC3) Topical Local Anesthetics
AHFS code 72:00.00.00
AHFS class Local Anesthetics
FDB label name LIDOCAINE 5% OINTMENT
FDB brand name Lidocaine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 014476
  • GCN: 30750
  • GPI-14 (Medi-Span): 90850060004210
  • HICL (First Databank): 010705
  • AHFS class code: 72:00.00.00
  • RxCUI (RxNorm): 1543069
Why two NDCs? The FDA registers this code as 64380-789-32 — 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 → 64380-0789-32. 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 LIDOCAINE 5% OINTMENT Ingredient Lidocaine
📗 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 gPer package
Retail pharmacies payNADAC · weekly $0.159 $5.63 / 35.44 g
Medicaid paysCMS SDUD · 12 mo $0.4025 $14.26 / 35.44 g
Medicare drug plans payPart D · Q2 2026 $0.2915 $10.33 / 35.44 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jun 2022 Jan 2024 May 2026 $0.227 $0.159
▼ Down 28% over the last 21 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
64380-0789-23 64380-789-23 30 g in 1 TUBE $0.1576 / g $4.73 2019-01-01 — Discontinued by firm
64380-0789-32 You're viewing this Main listing 35.44 g in 1 TUBE $0.1589 / g $5.63 2019-01-01 — Discontinued by firm
64380-0789-33 64380-789-33 50 g in 1 JAR $0.1378 / g $6.89 2019-01-01 — Discontinued by firm

Per g, this pack runs about 15% above the cheapest pack (50 g, $0.1378 vs $0.1589 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 56% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 35.44 g — 35.44 g in 1 tube.
How does this package differ from NDC 64380-0789-23?
Both are Lidocaine 50 mg/g Ointment — the drug itself is identical. This page's package is the 35.44 g one, while NDC 64380-0789-23 is the 30 g package. Per-g NADAC also differs: $0.1589 here vs $0.1576 for the 30 g pack.
What NDC number is used to bill for this package of Lidocaine 50 mg/g Ointment?
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
Lidocaine 50 mg/g 51672-3008-03 Sun 50 g $0.144 AT Discontinued save 9%
Lidocaine 50 mg/g 33342-0405-30 Macleods 1 tube $0.154 AT Availability likely save 3%
Lidocaine 50 mg/g 51672-3020-02 Sun 1 tube $0.154 AT Availability likely save 3%
Lidocaine 50 mg/g 62332-0424-30 Alembic 1 tube $0.154 AT Availability likely save 3%
Lidocaine 50 mg/gthis 64380-0789-32 Strides 35.44 g $0.159 AT Discontinued —
Lidocaine 50 mg/g 00168-0204-37 Fougera 1 tube $0.162 AT Availability likely +2%
lidocaine 50 mg/g 16714-0878-01 Northstar 1 tube $0.162 AT Availability likely +2%
lidocaine 50 mg/g 68462-0418-20 Glenmark 1 tube $0.162 AT Availability likely +2%
Lidocaine 50 mg/g 70752-0113-03 QUAGEN 1 tube $0.162 AT Availability likely +2%
lidocaine 50 mg/g 75834-0333-30 Nivagen 30 g $0.399 — Availability likely +151%
Leader Maximum Strength Hemorrhoidal Relief 50 mg/g 70000-0650-01 Cardinal 1 tube $0.399 — Availability likely +151%
Lidocaine 5 g/100g 00362-0221-10 Septodont, 50 g — AT FDA listed —
Lidocaine 50 mg/g 17856-3008-01 ATLANTIC 120 syringes — AT FDA listed —
Lidocaine 50 mg/g 46708-0424-30 Alembic 1 tube — AT FDA listed —
lidocaine 50 mg/g 50090-7922-00 A-S 1 tube — AT FDA listed —
Lidocaine 50 mg/g 51407-0383-35 Golden 1 tube — AT FDA listed —
Lidocaine 50 mg/g 59651-0591-30 Aurobindo 1 tube — AT FDA listed —
Lidocaine 50 mg/g 63629-2503-01 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 63629-2504-01 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 63629-8848-01 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 65162-0918-41 Amneal 150 g — AT FDA listed —
Lidocaine 50 mg/g 68071-3792-05 NuCare 1 jar — AT FDA listed —
Lidocaine 50 mg/g 68788-4050-05 Preferred 1 jar — AT FDA listed —
Lidocaine 50 mg/g 68788-7376-03 Preferred 1 tube — AT FDA listed —
Lidocaine 50 mg/g 68788-7766-05 Preferred 50 g — AT FDA listed —
lidocaine 50 mg/g 68788-8396-05 Preferred 50 g — AT FDA listed —
Lidocaine 50 mg/g 70518-3746-00 REMEDYREPACK 1 tube — AT FDA listed —
lidocaine 50 mg/g 70518-3902-00 REMEDYREPACK 50 g — AT FDA listed —
lidocaine 50 mg/g 70518-3972-00 REMEDYREPACK 50 g — AT FDA listed —
Lidocaine 50 mg/g 70518-4192-00 REMEDYREPACK 50 g — AT FDA listed —
Lidocaine 50 mg/g 71205-0288-50 Proficient 1 jar — AT FDA listed —
Lidocaine 50 mg/g 71205-0342-44 Proficient 1 tube — AT FDA listed —
Lidocaine 50 mg/g 71205-0429-30 Proficient 1 tube — AT FDA listed —
lidocaine 50 mg/g 71205-0500-44 Proficient 1 tube — AT FDA listed —
Lidocaine 50 mg/g 71205-0549-44 Proficient 35.44 g — AT FDA listed —
lidocaine 50 mg/g 71205-0717-50 Proficient 50 g — AT FDA listed —
Lidocaine 50 mg/g 71205-0814-44 Proficient 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 71335-2856-01 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 72162-2068-02 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 72162-2084-02 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 72189-0165-35 DIRECT 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0168-35 DIRECT 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0211-50 DIRECT 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0488-50 Direct_Rx 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0493-35 Direct_Rx 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0499-50 Direct_Rx 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0601-35 Direct_rx 35 g — AT FDA listed —
lidocaine 50 mg/g 76420-0125-50 Asclemed 50 g — AT FDA listed —
Lidocaine 50 mg/g 76420-0131-50 Asclemed 50 g — AT FDA listed —
lidocaine 50 mg/g 76420-0550-35 Asclemed 1 tube — AT FDA listed —
Lidocaine 50 mg/g 80425-0247-01 Advanced 50 g — AT FDA listed —
Lidocaine 50 mg/g 80425-0248-01 Advanced 50 g — AT FDA listed —
Lidocaine 50 mg/g 80425-0324-01 Advanced 1 tube — AT FDA listed —
Lidocaine 50 mg/g 80425-0442-01 Advanced 50 g — AT FDA listed —
lidocaine 50 mg/g 80425-0450-01 Advanced 1 tube — AT FDA listed —
Lidocaine 50 mg/g 80425-0509-01 Advanced 1 tube — AT FDA listed —
Lidocaine 50 mg/g 80425-0538-01 Advanced 1 jar — AT FDA listed —
lidocaine 50 mg/g 80425-0554-01 Advanced 50 g — AT FDA listed —
Lidocaine 50 mg/g 83008-0044-50 Quality 1 jar — AT FDA listed —
Lidocaine 50 mg/g 83008-0067-50 Quality 50 g — AT FDA listed —
lidocaine 50 mg/g 85509-1418-03 PHOENIX 1 tube — AT FDA listed —
Lidocaine 50 mg/g 85509-1424-05 PHOENIX 50 g — AT FDA listed —
Lidocaine 50 mg/g 85509-1918-01 PHOENIX 50 g — AT FDA listed —
Lidocaine 50 mg/g 85509-3008-05 PHOENIX 1 jar — AT FDA listed —
Lidocaine 50 mg/g 87063-0144-50 Asclemed 1 tube — AT FDA listed —
Maximum Strength Hemorrhoidal Relief 50 mg/g 51316-0226-00 CVS 1 tube — — FDA listed —
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger Cots 50 mg/g 51316-0229-00 CVS 1 tube — — FDA listed —
Microcaine Topical Analgesic 50 mg/g 67194-0022-01 Unit 15 g — — FDA listed —
DR REAL NUMB Topical Anorectal 50 mg/g 83800-0430-00 FUZZYLULU 1 tube — — FDA listed —
RectaEase Hemorrhoid Relief Cream 50 mg/g 69396-0070-01 Trifecta 1 tube — — FDA listed —
Numb520 50 mg/g 63742-0033-01 Clinical 1 bottle — — FDA listed —
Numb 520 50 mg/g 72654-0033-02 Ebanel 125 g — — FDA listed —
PUREGEN LABS Maximum Strength Lidocaine 50 mg/g 80513-0813-06 Advanced 170 g — — FDA listed —
Numb Master 50 mg/g 63742-0032-01 Clinical 1 bottle — — FDA listed —
Numb25 50 mg/g 63742-0035-01 Clinical 38 g — — FDA listed —
Recticare 50 mg/g 00496-0892-15 Ferndale 15 g — — FDA listed —
Numb25 50 mg/g 72654-0036-02 Ebanel 125 g — — FDA listed —
Lmx5 50 mg/g 00496-0883-15 Ferndale 15 g — — FDA listed —
HemRid Anorectal Cream 50 mg/g 82620-0001-01 KKA 1 tube — — FDA listed —
Lidocaine 50 mg/g 58980-0823-30 STRATUS 1 tube — — FDA listed —
Quick Numb 50 mg/g 63742-0333-01 Clinical 35.43 g — — FDA listed —
Lidocaine 5% Cream 50 mg/g 82461-0420-30 Medcore 1 tube — — FDA listed —
Dr. Care Numbing Cream 50 mg/g 84019-0038-01 Shengnan 30 g — — FDA listed —
Equate Hemorrhoid Relief 50 mg/g 79903-0428-01 Walmart 1 tube — — FDA listed —
Lidocaine 50 mg/g 50090-8011-00 A-S 1 tube — AT FDA listed —
Lidocaine Cream 50 mg/g 71457-0525-15 InvaDerm 1 tube — — FDA listed —
Lidocaine 50 mg/g 50090-8040-00 A-S 1 tube — AT FDA listed —
Flarestop Hemorrhoid Lidocaine 50 mg/g 87989-0013-00 Chelsea 1 tube — — FDA listed —
Lidocaine 50 mg/g 80425-0594-01 Advanced 1 tube — AT FDA listed —
Lidocaine 50 mg/g 68788-4195-05 Preferred 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0692-50 Direct_Rx 50 g — AT 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

🏛️
2019
On the market since
Jan 2019
📍
2026
Currently FDA-listed
7 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerStrides Pharma Science Limited
Application holderSTRIDES PHARMA GLOBAL PTE LTD
FDA applicationANDA210958 (ANDA)
Labeler code64380
First marketedJan 2019
Product typeHuman Prescription Drug
Portfolio195 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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 49 words ▾

INDICATIONS AND USAGE Lidocaine Ointment 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION When Lidocaine Ointment 5% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind. Adult: A single application should not exceed 5 g of Lidocaine Ointment 5%, containing 250 mg of Lidocaine base (equivalent chemically to approximately 300 mg of lidocaine hydrochloride). This is roughly equivalent to squeezing a six (6) inch length of ointment from the tube.

In a 70 kg adult this dose equals 3.6 mg/kg (1.6 mg/lb) lidocaine base. No more than one-half tube, approximately 17-20 g of ointment or 850-1000 mg lidocaine base, should be administered in any one day. Although the incidence of adverse effects with Lidocaine Ointment 5% 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.

Dosage for children: It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children less than ten years who have a normal lean body mass and a normal lean body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example a child of five years weighing 50 lbs., the dose of lidocaine should not exceed 75-100 mg when calculated according to Clark's rule.

In any case, the maximum amount of lidocaine administered should not exceed 4.5 mg/kg (2 mg/lb) of body weight. Administration: For medical use, apply topically for adequate control of symptoms. The use of a sterile gauze pad is suggested for application to broken skin tissue.

Apply to the tube prior to intubation. In dentistry, apply to previously dried oral mucosa. Subsequent removal of excess saliva with cotton rolls or saliva ejector minimizes dilution of the ointment, permits maximum penetration, and minimizes the possibility of swallowing the topical ointment.

For use in connection with the insertion of new dentures, apply to all denture surfaces contacting mucosa. IMPORTANT: Patients should consult a dentist at intervals not exceeding 48 hours throughout the fitting period.

⛔ Contraindications 27 words ▾

CONTRAINDICATIONS Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine Ointment 5%.

⚠️ Warnings ~1 min read ▾

WARNINGS EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS, PATIENTS 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. Lidocaine Ointment 5% should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.

Methemoglobinemia 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. 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 Lidocaine Ointment USP, 5% 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.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. 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: Central nervous system: CNS manifestations are excitatory and/or depressant and may be characterized by light headedness, 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. Cardiovascular system: Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. Allergic: 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. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

🧒 Pediatric Use 53 words ▾

Pediatric Use: Dosage in children should be reduced, commensurate with age, body weight and physical condition. Caution must be taken to avoid overdosage when applying Lidocaine Ointment 5% to large areas of injured or abraded skin, since the systemic absorption of lidocaine may be increased under such conditions. See DOSAGE and ADMINISTRATION .

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (see ADVERSE REACTIONS , WARNINGS , and PRECAUTIONS ). 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 by 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, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or 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. Dialysis is of negligible value in the treatment of acute overdosage with Lidocaine.

The oral LD 50 of lidocaine HCI in non-fasted female rats is 459 (346-773) mg/kg (as the salt) and 214 (159-324) mg/kg (as the salt) in fasted female rats.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Mechanism 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. Onset of anesthesia: Lidocaine Ointment 5% effects local, topical anesthesia. The onset of action is 3-5 minutes.

It is ineffective when applied to intact skin. Hemodynamics: 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.

Pharmacokinetics and metabolism: Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon the specific site of application, duration of exposure, concentration, and total dosage. 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 appears in the circulation because of biotransformation in the liver.

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.

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. Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2.0 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 two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects.

Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6.0 mcg free base per mL. In the rhesus monkey arterial blood levels of 18-21 mcg /mL have been shown to be threshold for convulsive activity.

🧬 Mechanism of Action 90 words ▾

Mechanism 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. Onset of anesthesia: Lidocaine Ointment 5% effects local, topical anesthesia. The onset of action is 3-5 minutes.

It is ineffective when applied to intact skin. Hemodynamics: 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.

📦 How Supplied / Storage and Handling 98 words ▾

HOW SUPPLIED Lidocaine Ointment USP, 5% is supplied as a white to off white translucent, homogenous ointment, free of lumps and foreign matter and available in the following packs: 30 g laminate tubes with a child-resistant cap NDC 64380-789-23, 35.44 g laminate tubes with a child-resistant cap NDC 64380-789-32 and 50 g double wall jar, NDC 64380-789-33 Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Manufactured by: Strides Pharma Science Limited.

Bengaluru, India. Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816 Revised: 11/2018

📋 Description 63 words ▾

DESCRIPTION Lidocaine Ointment 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGE for specific uses. Lidocaine Ointment 5% contains lidocaine, which is chemically designated as acetamide, 2- (diethylamino)- N -(2,6-dimethylphenyl)-, and has the following structural formula: Composition of Lidocaine Ointment USP, 5%: acetamide, 2-(diethylamino)- N -(2,6-dimethylphenyl)-, (lidocaine) 5% in a water miscible ointment vehicle containing polyethylene glycols.

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💬 Information for Patients 156 words ▾

Information for Patients: Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to 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. 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 the use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating. 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.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. (See WARNINGS and ADVERSE REACTIONS ). The lowest dosage that results in effective anesthesia should be used 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 and/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 condition.

Lidocaine should also be used with caution in patients with severe shock or heart block. Lidocaine Ointment 5% should be used with caution in patients with known drug sensitivities. Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine.

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 protocol for the management of malignant hyperthermia should be available. Early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature elevation.

Successful outcome is dependent on early diagnosis, prompt discontinuance of the suspect triggering agent(s) and institution of treatment, including oxygen therapy, indicated supportive measures and dantrolene (consult dantrolene sodium intravenous package insert before using). Information for Patients: Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to 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.

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 the use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating.

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. Drug Interactions 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 Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic 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 Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Usage in Pregnancy: Teratogenic Effects. Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have reveal… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 34 words ▾

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lidocaine is administered to a nursing woman.

📄 Package Label / Principal Display Panel 39 words ▾

PRINCIPAL DISPLAY PANEL Lidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Laminate Tube with Child - Resistant Cap 30 g tube label 35.44 g tube label 30 g tube label 35.44 g tube 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
421
Units reimbursed last 4 qtrs
15.8K
Gross reimbursed last 4 qtrs
$6.4K
Avg / prescription
$15.09
Avg / unit
$0.4025
Latest quarter Q1 2026
38Rx
Medicaid pays / g
$0.4025
gross reimbursed
vs
NADAC / g
$0.1589
acquisition cost
=
Spread
+$0.2436
+153% vs cost
What Medicaid paid per g (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 ⓘ
71% FFS 29% MCO
Fee-for-service · 297 Rx Managed care · 124 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 2,574 units · 25.6 per 100k residents MI New York: 7,695 units · 39.3 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 638 units · 5.1 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 957 units · 7.4 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 2,815 units · 7.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 149 units · 3.3 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported 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: 958 units · 13.4 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.339.3
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 York 39.3 /100k
2 Michigan 25.6 /100k
3 Tennessee 13.4 /100k
4 Pennsylvania 7.4 /100k
5 California 7.2 /100k
6 Illinois 5.1 /100k
7 Kentucky 3.3 /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.
35.44 g this page64380-0789-32 421 Rx · $6,354
50 g64380-0789-33 329 Rx · $5,937
30 g64380-0789-23 No Medicaid data
Drug total (last 4 qtrs): 750 Rx · 37,048 units · $12,291 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 Lidocaine — the program that covers self-administered drugs. 17 manufacturers.
⚠️ 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 Lidocaine. 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
$53.12M
Claims incl. refills
593.7K
Beneficiaries
367.9K
Spend / beneficiary
$144.39
Spend / claim
$89.46
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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 g (64380-0789-23), 50 g (64380-0789-33). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Strides Pharma Science Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 64380-0787-06 · Strides 64380-0791-01 · Strides →
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.