First Aid Only Burn Lidocaine Hydrochloride 20 mg/g Gel, 3.5 g
by Acme United Corporation · 3.5 g in 1 PACKET (0924-5010-00)
NDC 00924-5010-00
🏷️ FDA NDC (as labeled)
0924-5010-00
billing pads the labeler segment with a zero
This package
Contains3.5 g
Pack sizes3 compare ↓
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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
FDA NDC (as labeled)
0924-5010-00
Product NDC
0924-5010
11-digit billing NDC
00924501000
RxCUI
1011852
UNII
V13007Z41A
UPC
0092265074698
Application #
M017
SPL Set ID
9af39fcd-0a57-26d0-e053-2a95a90a99a0
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
2020-01-02
Route
TOPICAL
Dosage form
GEL
Substance
LIDOCAINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 0924-5010-00 — 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 → 00924-5010-00. 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.
🏭 Manufacturer & labeler
LabelerAcme United Corporation
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code00924
First marketedJan 2020
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.
🩺 Clinical
📗 Our plain-language guide HelloPharmacist
- It's best to avoid using two lidocaine products at the same time unless your doctor says it's okay. When you use multiple products containing a local anesthetic, the total amount a...
- Can I use a lidocaine patch and a lidocaine cream at the same time?
- No — please don't do this. Heat significantly increases how much lidocaine is absorbed through your skin, which can push drug levels in your blood higher than they should be. Stick...
- Can I put a heating pad on the area where I applied a lidocaine patch?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Lidocaine Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 71DD5V995L
A synthetic polymer derived from acrylic acid, crosslinked to form a gel-like substance. It thickens formulations, improves texture, and helps distribute active ingredients evenly in topical products like creams and gels.
-
UNII 4Q93RCW27E
A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
-
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 crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylparaben, Propylene Glycol, Purified water, Tea Tree Leaf Oil, 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.
💲 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 system | Per g | Per 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.
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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 | $0.887 | 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/g 00924-5004-00 | Acme | 3.5 g | — | — | FDA listed | — |
| First Aid Only Burn 20 mg/gthis 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
🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 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.
🔬 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 Lidocaine Hydrochloride — the ingredient across all brands.
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00924-5010-00 You're viewing this | 3.5 g in 1 PACKET (0924-5010-00) | 2020-01-02 | Active |
| 00924-5010-01 | 6 PACKET in 1 CARTON (0924-5010-01) / 3.5 g in 1 PACKET | 2020-01-02 | Active |
| 00924-5010-02 | 25 PACKET in 1 CARTON (0924-5010-02) / 3.5 g in 1 PACKET | 2020-01-02 | Active |
Pack size FAQ
What quantity is in NDC 00924-5010-00?
NDC 00924-5010-00 contains 3.5 g — 3.5 g in 1 packet.
What is the difference between NDC 00924-5010-00 and NDC 00924-5010-01?
Both are First Aid Only Burn Lidocaine Hydrochloride 20 mg/g Gel — the drug itself is identical. NDC 00924-5010-00 is the 3.5 g package, while NDC 00924-5010-01 is the 6 packets package.
What NDC number is used to bill for this package of First Aid Only Burn Lidocaine Hydrochloride 20 mg/g Gel?
Bill NDC 00924-5010-00 — the 11-digit billing format is 00924501000. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 FDA registers it as 0924-5010-00, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00924-5010-00, written without dashes as 00924501000. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00924-5010-00, the first segment (00924) is the labeler code FDA assigned to Acme United Corporation; the middle segment (5010) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
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 2 other package presentations of this same product, including 6 packets (00924-5010-01), 25 packets (00924-5010-02). 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.
📄 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
🎯 Indications and Usage ▾
USES Temporarily relieves pain associated with minor burns
⏱️ Dosage and Administration ▾
DIRECTIONS Adults and children 2 years and over: 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: consult a doctor
⚠️ Warnings ▾
WARNINGS For external use only. Avoid contact with eyes Do not use ▪ in large quantities, particularly over raw surfaces or blistered areas Stop use and ask a doctor if ▪condition worsens ▪symptoms persist for more than 7 days ▪symptoms clear up and occur again in a few days Keep out of reach of children. . If swallowed get medical help or contact Poison Control immediately
🧪 Active Ingredient ▾
• ACTIVE INGREDIENT Lidocaine Hydrochloride 2%
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENTS Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylparaben, Propylene Glycol, Purified water, Tea Tree Leaf Oil, Triethanolamine.
🎯 Purpose ▾
• PURPOSE External Analgesic
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.