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First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel 20 mg/g Gel, 25 packets — NDC 00924-5004-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel 20 mg/g Gel, 25 packets — NDC 0924-5004-03 (Billing 00924-5004-03)

by Acme United Corporation · 25 PACKET in 1 BOX / 3.5 g in 1 PACKET

This is a package of 25 packets of First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel 20 mg/g Gel from Acme United Corporation, marketed since Jun 2026 and currently FDA-listed.

NDC 00924-5004-03
🏷️ FDA NDC (as labeled) 0924-5004-03 billing pads the labeler segment with a zero
This package
Contains25 packets Pack sizes4 compare ↓
Product page 00924-5004-00 Also comes in: 3.5 g 0924-5004-00 5 packets 0924-5004-17 6 packets 0924-5004-01
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

⚠️
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) 0924-5004-03
Product NDC 0924-5004
11-digit billing NDC 00924500403
RxCUI 1011852
UNII V13007Z41A
UPC 0738743130103
Application # M003
SPL Set ID 5258cef2-0e5c-4ccd-e063-6394a90a9e5c
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 2026-06-01
Route TOPICAL
Dosage form GEL
Substance LIDOCAINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1011852
Why two NDCs? The FDA registers this code as 0924-5004-03 — a 4-4-2 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 labeler segment → 00924-5004-03. 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: 3.5 g 5 packets 6 packets
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
00924-5004-00 0924-5004-00 Main listing 3.5 g in 1 PACKET 2026-06-01 — Active
00924-5004-01 0924-5004-01 6 PACKET in 1 BOX / 3.5 g in 1 PACKET 2026-06-01 — Active
00924-5004-03 You're viewing this 25 PACKET in 1 BOX / 3.5 g in 1 PACKET 2026-06-01 — Active
00924-5004-17 0924-5004-17 5 PACKET in 1 BOX / 3.5 g in 1 PACKET 2026-06-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 25 packets — 25 packet in 1 box / 3.5 g in 1 packet.
How does this package differ from NDC 00924-5004-00?
Both are First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel 20 mg/g Gel — the drug itself is identical. This page's package is the 25 packets one, while NDC 00924-5004-00 is the 3.5 g package.
What NDC number is used to bill for this package of First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel 20 mg/g 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
Lidocaine Hydrochloride 20 mg/mL 76329-3013-05 International 25 vials $0.704 AT Availability likely —
glydo 20 mg/mL 25021-0673-76 Sagent 10 syringes $0.898 AT Availability likely —
Lidocaine Hydrochloride 20 mg/mL 76329-3011-05 International 25 vials $1.167 AT Availability likely —
Lidocaine Hydrochloride 20 mg/mL 76329-3012-05 International 25 vials $1.167 AT Availability likely —
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/gthis 00924-5004-03 Acme 25 packets — — 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: 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

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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

  • UNII 8Z5ZAL5H3V
    A synthetic polymer made from acrylate compounds. It acts as a thickener and stabilizer in topical formulations, helping create the right texture and prevent separation of ingredients.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII M629807ATL
    Imidazolidinyl urea is a synthetic preservative that prevents microbial growth in medicines. It's used in formulations to extend shelf life and maintain product safety during storage.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • 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.

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

The official label also statesacrylates/C10-30 alkyl acrylate crosscopolymer, carbomer, glycerin, imidurea, methylparaben, propylene glycol, propylparaben, purified water, tea tree oil, trolamine

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

LabelerAcme United Corporation
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code00924
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio59 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.

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 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

Use for the temporary relief of pain associated with • minor burns

⏱️ Dosage and Administration 36 words ▾

Directions • adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily • children under 2 years of age: do not use consult a doctor

⚠️ Warnings 78 words ▾

Warnings For external use only Avoid Contact with eyes Do not use • on wounds or damaged skin • in large quantities, particularly over raw surfaces or blistered areas Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

🧪 Active Ingredient 8 words ▾

Active ingredient Lidocaine Hydrochloride 2% Purpose External Analgesic

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients acrylates/C10-30 alkyl acrylate crosscopolymer, carbomer, glycerin, imidurea, methylparaben, propylene glycol, propylparaben, purified water, tea tree oil, trolamine

🎯 Purpose 3 words ▾

Purpose External Analgesic

📄 Do Not Use 20 words ▾

Do not use • on wounds or damaged skin • in large quantities, particularly over raw surfaces or blistered areas

📄 Stop Use and Ask a Doctor If 29 words ▾

Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📄 Questions or Comments 2 words ▾

Questions? 800-835-2263

📄 Package Label / Principal Display Panel 4 words ▾

Package Labeling: Carton Label

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

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 Acme United Corporation. 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 3 other package presentations of this same product, including 3.5 g (00924-5004-00), 5 packets (00924-5004-17), 6 packets (00924-5004-01). 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?
Acme United Corporation 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.
← 00924-1133-00 · Acme 00924-5010-00 · Acme →
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.