Home › NDC Lookup › Ingredients › Lidocaine Hydrochloride › 73698-0281-01
SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDE 30 mg/mL Gel, 118 mL — NDC 73698-0281-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDE 30 mg/mL Gel, 118 mL — NDC 73698-281-01 (Billing 73698-0281-01)

by ScleraCare, LLC · 118 mL in 1 BOTTLE

This is a package of 118 mL of SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDE 30 mg/mL Gel from ScleraCare, LLC, marketed since Mar 2022 and currently FDA-listed.

NDC 73698-0281-01
🏷️ FDA NDC (as labeled) 73698-281-01 billing pads the product segment with a zero
This package
Contains118 mL Pack sizes2 compare ↓
Product page 73698-0281-00 Also comes in: 5 ml 73698-281-00
OTC 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 →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 73698-281-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
73698 labeler · 281 product · 01 package
Package marketed since
Mar 21, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0195893030750
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) 73698-281-01
Product NDC 73698-281
11-digit billing NDC 73698028101
RxCUI 1372891
UNII V13007Z41A
UPC 0195893030750
Application # M017
SPL Set ID 488ace02-fc0b-4d13-ab89-0e1640e915e5
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-21
Route TOPICAL
Dosage form GEL
Substance LIDOCAINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1372891
Why two NDCs? The FDA registers this code as 73698-281-01 — 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 → 73698-0281-01. 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

📗 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 5 ml
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 Marketing startMarketing endStatus
73698-0281-00 73698-281-00 Main listing 5 mL in 1 PACKET Sample 2022-03-21 — Active
73698-0281-01 You're viewing this 118 mL in 1 BOTTLE 2022-03-21 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 118 mL — 118 ml in 1 bottle.
How does this package differ from NDC 73698-0281-00?
Both are SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDE 30 mg/mL Gel — the drug itself is identical. This page's package is the 118 mL one, while NDC 73698-0281-00 is the 5 ml package.
What NDC number is used to bill for this package of SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDE 30 mg/mL Gel?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
SCLERA CARE Topical Anesthetic Gel 30 mg/mLthis 73698-0281-01 ScleraCare, 118 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 6VNO72PFC1
    A natural oil extracted from avocado fruit. It's used in medicines as an emollient and carrier to help dissolve or deliver active ingredients and improve how the product feels on skin or mucous membranes.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII YY7C30VXJT
    A natural plant extract from cucumber that adds flavor and freshness to medicines. It may also serve as a moisturizing agent or mild preservative in topical or oral formulations.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII C269C4G2ZQ
    Sodium alginate is a natural thickener and gelling agent derived from seaweed. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust texture, and a disintegrant to help the tablet or capsule break apart for absorption.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesa-Bisabalol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Opuntia Vulgaris (Prickly Pear) Extract, Persea gratissima (Avocado) Oil, Phenoxyethanol, Polysorbate-20, Sodium Alginate, Squalane, Triethanolamine.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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

LabelerScleraCare, LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code73698
First marketedMar 2022
Product typeHuman Otc Drug
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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 24 words ▾

Uses: • For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

⏱️ Dosage and Administration 31 words ▾

Directions: • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. • Children under two-years of age: Consult a physician.

⚠️ Warnings 93 words ▾

Warnings: • not intended for ingestion. For external use only When using this product • Avoid contact with eyes Do not use • in large quantities, particularly over raw surfaces or blistered areas Stop use and ask a doctor if symptoms persist for more than seven days. Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center right away. • Do not apply to wounds or damaged skin. • Do not bandage tightly.

If pregnant or breast feeding, • contact a physician prior to use.

🧪 Active Ingredient 8 words ▾

Active Ingredient: Lidocaine hydrochloride 3.00% Purpose Topical Anesthetic

🧪 Inactive Ingredients 41 words ▾

Inactive Ingredients: a-Bisabalol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Opuntia Vulgaris (Prickly Pear) Extract, Persea gratissima (Avocado) Oil, Phenoxyethanol, Polysorbate-20, Sodium Alginate, Squalane, Triethanolamine.

🎯 Purpose 3 words ▾

Purpose Topical Anesthetic

📄 Do Not Use 14 words ▾

Do not use • in large quantities, particularly over raw surfaces or blistered areas

📄 When Using This Product 9 words ▾

When using this product • Avoid contact with eyes

📄 Stop Use and Ask a Doctor If 14 words ▾

Stop use and ask a doctor if symptoms persist for more than seven days.

🤰 If Pregnant or Breast-Feeding 12 words ▾

If pregnant or breast feeding, • contact a physician prior to use.

📄 Keep Out of Reach of Children 34 words ▾

Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center right away. • Do not apply to wounds or damaged skin. • Do not bandage tightly.

📄 Questions or Comments 5 words ▾

Question? 337-526-6744 (M-F) (9-5pm CST)

📄 Package Label / Principal Display Panel 6 words ▾

Package Labeling:5ml Label

Package Labeling:118ml Label2

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

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 SCLERA CARE Topical Anesthetic Gel (this brand).

Top reported reactions

Infusion Site Pain729
Nausea491
Infusion Site Erythema456
Headache438
Dyspnoea426
Diarrhoea423
Fatigue369

Reporter sex

6,521 reports

Serious outcomes

Death560
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,456 164
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.

About this NDC listing & data coverage

Over-the-counter (OTC) product
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 ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ScleraCare, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 5 ml (73698-0281-00). 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?
ScleraCare, LLC 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 73691-0296-00 · Coral 73712-0114-12 · Bonafide →
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.