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2677 First Aid Burn Cream 13 mg/10000mg; 50 mg/10000mg Cream — NDC 58228-2677-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

2677 First Aid Burn Cream 13 mg/10000mg; 50 mg/10000mg Cream — NDC 58228-2677-1 (Billing 58228-2677-01)

by ProStat First Aid LLC · 100 BOX in 1 CASE / 10 PACKET in 1 BOX / 900 mg in 1 PACKET

This is a package of 2677 First Aid Burn Cream 13 mg/10000mg; 50 mg/10000mg Cream from ProStat First Aid LLC, marketed since Jul 2023 and currently FDA-listed. It is this product's only package size.

NDC 58228-2677-01
🏷️ FDA NDC (as labeled) 58228-2677-1 billing pads the package segment with a zero
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 58228-2677-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58228 labeler · 2677 product · 1 package
Package marketed since
Jul 21, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0814889010704
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58228-2677-1
Product NDC 58228-2677
11-digit billing NDC 58228267701
RxCUI 1012100
UNII F5UM2KM3W7, V13007Z41A
UPC 0814889010704
Application # M017
SPL Set ID ff5bb628-8ef7-4540-e053-6394a90a55ed
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 2023-07-21
Route TOPICAL
Dosage form CREAM
Substance BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1012100
Why two NDCs? The FDA registers this code as 58228-2677-1 — a 5-4-1 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 package segment → 58228-2677-01. 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 Quaternary ammonium compounds class.

Drug family (ATC) Quaternary ammonium compounds, Medicated dressings with antiinfectives, Antiseptics
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

🧪 What is this product?

This is an over-the-counter topical cream marketed under the FDA's OTC monograph rule for first aid burn products. It contains benzalkonium chloride, an antiseptic agent typically used to help reduce bacteria on the skin, and lidocaine hydrochloride, a local anesthetic commonly used to numb minor pain and discomfort. The cream is intended for topical application to minor burns and similar minor skin injuries. Because this is an OTC monograph product, it follows established FDA guidelines for this category rather than undergoing individual product approval.

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.
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
58228-2677-01 You're viewing this Main listing 100 BOX in 1 CASE / 10 PACKET in 1 BOX / 900 mg in 1 PACKET 2023-07-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
First Aid Only First Aid/Burn 5 mg/g; 1.3 mg/g 00924-5011-00 Acme 9 g — — FDA listed —
First Aid Only First Aid-Burn 1.3 mg/g; 5 mg/g 00924-5702-00 Acme 9 g — — FDA listed —
First Aid Only First Aid/Burn 5 mg/g; 1.3 mg/g 00924-5730-00 Acme 9 g — — FDA listed —
Xpect First Aid Cream .13 g/100g; .5 g/100g 42961-0259-02 Cintas 9 g — — FDA listed —
GENUINE FIRST AID Antiseptic Pain Relieving .13 g/100g; .5 g/100g 43473-0015-01 Nantong 9 g — — FDA listed —
SAFLY Burn .5 g/100g; .13 g/100g 43473-0039-01 Nantong 9 g — — FDA listed —
Firstar Burn .5 g/100g; .13 g/100g 43473-0040-01 Nantong 9 g — — FDA listed —
Aosi Healthcare Burn .5 g/100g; .13 g/100g 43473-0055-01 Nantong 9 g — — FDA listed —
health and beyond BURN .5 g/100g; .13 g/100g 43473-0064-01 Nantong 9 g — — FDA listed —
Proheal Burn .5 g/100g; .13 g/100g 43473-0066-01 Nantong 9 g — — FDA listed —
Everlit Care Burn .5 g/100g; .13 g/100g 43473-0113-01 Nantong 9 g — — FDA listed —
Burn with Lidocaine 1.3 mg/g; 5 mg/g 47682-0260-12 Unifirst 10 packets — — FDA listed —
Medi-First Burn with Lidocaine 1.3 mg/g; 5 mg/g 47682-0270-12 Unifirst 10 packets — — FDA listed —
Green Guard Derma-Caine Burn 1.3 mg/g; 5 mg/g 47682-0319-35 Unifirst 144 packets — — FDA listed —
Medi-First Plus Burn with Lidocaine 1.3 mg/g; 5 mg/g 47682-0930-73 Unifirst 25 packets — — FDA listed —
Medi-First Plus Burn Cream 5 mg/g; 1.3 mg/g 47682-0940-73 Unifirst 25 packets — — FDA listed —
Medi-First Burn with Lidocaine 1.3 mg/g; 5 mg/g 47682-0984-73 Unifirst 25 packets — — FDA listed —
Medi-First Plus Burn with Lidocaine 1.3 mg/g; 5 mg/g 47682-0985-73 Unifirst 25 packets — — FDA listed —
Burn Treatment .13 g/100g; .5 g/100g 49687-0014-00 CMC 10 pouches — — FDA listed —
Refill 3 .13 g/100g; .5 g/100g 49687-0017-00 CMC 9 g — — FDA listed —
First Aid and Burn .13 g/100g; .5 g/100g 50332-0037-01 HART 6 packets — — FDA listed —
First Aid and Burn .13 g/100g; .5 g/100g 50332-0091-01 HART 6 packets — — FDA listed —
Refill 3 .13 g/100g; .5 g/100g 50814-0017-01 GFA 9 g — — FDA listed —
Genuine First Aid First Aid Antiseptic Pain Relieving Cream 1.3 mg/g; 5 mg/g 50814-0059-01 GFA 9 g — — FDA listed —
Genuine First Aid Pain Relieving Cream 1.3 mg/g; 5 mg/g 50814-0079-01 GFA 9 g — — FDA listed —
CareALL First Aid Burn Cream .005 g/g; .0013 g/g 51824-0096-14 New 144 packets — — FDA listed —
Be Smart Get Prepared Burn Cream .13 g/100g; .5 g/100g 55550-0521-01 Total 9 g — — FDA listed —
Burn Cream 1.3 mg/g; 5 mg/g 55550-0902-21 Total 9 g — — FDA listed —
First Aid Burn Cream .5 g/100g; .13 g/100g 58228-2044-02 ProStat 25 packets — — FDA listed —
First Aid Burn Cream 50 mg/10000mg; 13 mg/10000mg 58228-2309-01 ProStat 2000 packets — — FDA listed —
2677 First Aid Burn Cream 13 mg/10000mg; 50 mg/10000mgthis 58228-2677-01 ProStat 10 packets — — FDA listed —
Burn Cream .0013 g/g; .005 g/g 58228-7000-01 Prostat 25 packets — — FDA listed —
Burn Cream .0013 g/g; .005 g/g 58228-7010-01 Prostat 10 packets — — FDA listed —
First Aid Burn .5 g/100g; .13 g/100g 59898-0902-01 Water-Jel 1728 packets — — FDA listed —
First Aid and Burn 1.3 mg/g; 5 mg/g 61010-5701-04 Safetec 144 packets — — FDA listed —
Burn First Aid 50 mg/10000mg; 13 mg/10000mg 67777-0007-50 Dynarex 144 packets — — FDA listed —
Burn Cream .005 g/g; .0013 g/g 69396-0105-09 Trifecta 144 packets — — FDA listed —
Burn Cream .005 g/g; .0013 g/g 69396-0124-09 Trifecta 25 packets — — FDA listed —
Burn Cream .005 g/g; .0013 g/g 69396-0136-10 Trifecta 10 packets — — FDA listed —
Burn Cream .005 g/g; .0013 g/g 69396-0146-10 Trifecta 10 packets — — FDA listed —
ECOLAB Burn Cream 5 mg/g; 1.3 mg/g 71338-0123-73 ECOLAB 25 packets — — FDA listed —
Medi-First 5 mg/g; 1.3 mg/g 71927-0019-02 Orazen 25 pouches — — FDA listed —
Ever Ready First Aid 5 mg/g; 1.3 mg/g 72976-0005-01 Ever 9 g — — FDA listed —
First Shield 5 mg/g; 1.3 mg/g 72976-0008-01 Ever 9 g — — FDA listed —
Burn .5 g/100g; .13 g/100g 73288-0007-01 NINGBO 9 g — — FDA listed —
Thompson Burn Cream with Lidocain 1.3 mg/g; 5 mg/g 73408-0060-12 Thompson 10 packets — — FDA listed —
Thompson Burn Cream with Lidocaine 5 mg/g; 1.3 mg/g 73408-0160-12 Thompson 10 packets — — FDA listed —
Crane Safety Burn 5 mg/g; 1.3 mg/g 73408-0260-12 Crane 10 packets — — FDA listed —
Thompson Burn Cream with Lidocaine 1.3 mg/g; 5 mg/g 73408-0940-73 Thompson 25 packets — — FDA listed —
Thompson Burn Cream with Lidocaine 5 mg/g; 1.3 mg/g 73408-0985-73 Thompson 25 packets — — FDA listed —
First Aid Burn 5 mg/g; 1.3 mg/g 82749-0009-01 Epic 144 packets — — FDA listed —
First Aid Antiseptic Pain Relieving 1.3 mg/g; 5 mg/g 82996-0002-01 Hubei 9 g — — FDA listed —
First Aid Antiseptic Pain Relieving Cream 1.3 mg/g; 5 mg/g 83165-0004-00 Hubei 1 patch — — FDA listed —
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride 1.3 mg/g; 5 mg/g 84219-0002-00 M-star 9 g — — FDA listed —
First Aid Burn 5 mg/g; 1.3 mg/g 87251-0009-01 4 144 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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

What it looks like

ShapeFreeform
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII I835H2IHHX
    A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 2Y53S6ATLU
    Dimethicone 350 is a silicone-based oil. It works as a lubricant and anti-foaming agent to help the medicine flow smoothly during manufacturing and reduce unwanted bubbles in the final product.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII MRJ667KA5E
    Methylcellulose is a plant-derived thickening agent made by chemically modifying cellulose. In medicines, it acts as a binder to hold ingredients together, a thickener to create the right consistency, and sometimes a disintegrant to help the tablet break apart when swallowed.
  • UNII CR6K9C2NHK
    A synthetic preservative derived from methylparaben. It prevents bacterial and fungal growth in medicines, extending shelf life and maintaining product safety during storage.
  • UNII 625NNB0G9N
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps keep the product safe and stable throughout its shelf life.
  • 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 statesButylated Hydroxytoluene, Cetomacrogol 1000, Cetostearyl Alcohol, Dimethicone, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

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

LabelerProStat First Aid LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code58228
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio27 products on file

More NDCs from ProStat First Aid LLC labeler code 58228

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 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

Use(s) For temporary relief of pain and itching associated with: • Sunburn • Minor burns • Insect bites • Cuts • Scrapes

⏱️ Dosage and Administration 45 words ▾

Directions Adults and children 2 years and older: • Clean the affected area • Apply a small amount of this product on the area 3 to 4 times daily • May be covered with a sterile bandage Children under 2 years: • Consult a doctor

⚠️ Warnings 101 words ▾

Warnings For External Use Only Do not use • In the eyes • Over large areas of the body or on deep puncture wounds, animal bites, or serious burns • In large quantities, particularly over raw surfaces or blistered areas Stop use and ask a doctor if • The condition gets worse • Condition clears up and recurs within a few days • Condition persists for more than 7 days If pregnant or breast feeding Ask a healthcare professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 10 words ▾

Active Ingredient Lidocaine Hydrochloride 0.5%

Active Ingredient Benzalkonium Chloride 0.13%

🧪 Inactive Ingredients 23 words ▾

Inactive Ingredients Butylated Hydroxytoluene, Cetomacrogol 1000, Cetostearyl Alcohol, Dimethicone, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

🎯 Purpose 6 words ▾

Purpose Topical Analgesic

Purpose Topical Antiseptic

📄 Do Not Use 35 words ▾

Do not use • In the eyes • Over large areas of the body or on deep puncture wounds, animal bites, or serious burns • In large quantities, particularly over raw surfaces or blistered areas

📄 Stop Use and Ask a Doctor If 30 words ▾

Stop use and ask a doctor if • The condition gets worse • Condition clears up and recurs within a few days • Condition persists for more than 7 days

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast feeding Ask a healthcare professional before use.

📄 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 (1-800-222-1222) right away.

📄 Other Information 27 words ▾

Other Information • Store in a cool, dry area 15º-25º C (59º-77º F) • Tamper evident sealed packets • Do not use any opened or torn packets

📄 Questions or Comments 9 words ▾

Questions? 1-888-900-2920 Monday - Friday 8AM - 4PM PST

📄 Package Label / Principal Display Panel 9 words ▾

Label PROSTAT First Aid Burn Cream PS-2677 BX MASTER

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 ProStat First Aid LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ProStat First Aid 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.
← 58228-2610-01 · Front 58228-2893-05 · ProStat →
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.