First Aid and Burn benzalkonium chloride, lidocaine .13 g/100g; .5 g/100g Cream, 2000 packets — NDC 50332-0091-09 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

First Aid and Burn benzalkonium chloride, lidocaine .13 g/100g; .5 g/100g Cream, 2000 packets — NDC 50332-0091-9 (Billing 50332-0091-09)

by HART Health · 2000 PACKET in 1 BOX, UNIT-DOSE / .9 g in 1 PACKET

This is a package of 2,000 packets of First Aid and Burn benzalkonium chloride, lidocaine .13 g/100g; .5 g/100g Cream from HART Health, marketed since Sep 2025 and currently FDA-listed.

NDC 50332-0091-09
🏷️ FDA NDC (as labeled) 50332-0091-9 billing pads the package segment with a zero
This package
Contains2000 packets Pack sizes5 compare ↓
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 →

NDC database record

One package, one record: these facts belong to NDC 50332-0091-9 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
50332 labeler · 0091 product · 9 package
Package marketed since
Sep 18, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5033200919 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50332-0091-9
Product NDC 50332-0091
11-digit billing NDC 50332009109
RxCUI 1012100
UNII F5UM2KM3W7, 98PI200987
Application # M
SPL Set ID 07d447f1-469c-4e34-b807-ede9a449e6ab
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 2025-09-18
Route TOPICAL
Dosage form CREAM
Substance BENZALKONIUM CHLORIDE; LIDOCAINE
Quick answers
  • RxCUI (RxNorm): 1012100
Why two NDCs? The FDA registers this code as 50332-0091-9 — 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 → 50332-0091-09. 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?

First Aid and Burn is a topical cream sold over the counter as part of the OTC monograph class of drugs. It contains benzalkonium chloride, an antiseptic agent typically used to help reduce bacteria on skin, and lidocaine, a local anesthetic commonly used to numb pain and itching. Together these ingredients are found in products meant to provide temporary relief and cleansing support for minor wounds, scrapes, and burns applied directly to the affected skin area.

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: 6 packets 10 packets 25 packets 144 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
50332-0091-01 50332-0091-1 Main listing 6 PACKET in 1 BOX, UNIT-DOSE / .9 g in 1 PACKET 2025-09-18 — Active
50332-0091-02 50332-0091-2 25 PACKET in 1 BOX, UNIT-DOSE / .9 g in 1 PACKET 2025-09-18 — Active
50332-0091-04 50332-0091-4 144 PACKET in 1 BOX, UNIT-DOSE / .9 g in 1 PACKET 2025-09-18 — Active
50332-0091-06 50332-0091-6 10 PACKET in 1 BOX, UNIT-DOSE / .9 g in 1 PACKET 2025-09-18 — Active
50332-0091-09 You're viewing this 2000 PACKET in 1 BOX, UNIT-DOSE / .9 g in 1 PACKET 2025-09-18 — Active

Pack size FAQ

What quantity is in this package?
This package contains 2000 packets — 2000 packet in 1 box, unit-dose / .9 g in 1 packet.
How does this package differ from NDC 50332-0091-01?
Both are First Aid and Burn benzalkonium chloride, lidocaine .13 g/100g; .5 g/100g Cream — the drug itself is identical. This page's package is the 2000 packets one, while NDC 50332-0091-01 is the 6 packets package.
What NDC number is used to bill for this package of First Aid and Burn benzalkonium chloride, lidocaine .13 g/100g; .5 g/100g Cream?
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
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/100gthis 50332-0091-09 HART 2000 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/10000mg 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

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year 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.

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 RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • 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 KME849MC7A
    Disodium HEDTA is a chelating agent, a chemical that binds to metal ions. It's used in medicines to prevent metal impurities from causing discoloration or degradation of the product.
  • 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 RD25J5V947
    A waxy mixture derived from vegetable oils and polyethylene glycol that helps emulsify and blend oil-based and water-based ingredients. It's used in creams and lotions to create a smooth, uniform texture and improve product stability.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • 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 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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 statesInactive Ingredients: aloe barbadensis leaf juice, cetearyl alcohol, disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate/PEG-100 stearate, maltodextrin, mineral oil, phenoxyethanol, propylene glycol, purified water, stearic acid, sodium hydroxide.

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

LabelerHART Health
FDA applicationM (OTC MONOGRAPH DRUG)
Labeler code50332
First marketedSep 2025
Product typeHuman Otc Drug
Portfolio36 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 15 words ▾

Uses: Temporary relief of pain and to help prevent infection in minor cuts scrapes burns

⏱️ Dosage and Administration 63 words ▾

Directions: do not use more than directed Adults and children 2 years of age and over: clean the affected area apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage Children under 2 years of age: ask a doctor

⚠️ Warnings 12 words ▾

Warnings: For external use only. See a doctor immediately for serious burns

🧪 Active Ingredient 11 words ▾

Active Ingredients (in each gram): Benzalkonium Chloride 0.13% Lidocaine HCl 0.5%

🧪 Inactive Ingredients 27 words ▾

Inactive Ingredients: aloe barbadensis leaf juice, cetearyl alcohol, disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate/PEG-100 stearate, maltodextrin, mineral oil, phenoxyethanol, propylene glycol, purified water, stearic acid, sodium hydroxide.

🎯 Purpose 5 words ▾

Purpose: Topical Antiseptic Topical Anesthetic

📄 Do Not Use 40 words ▾

Do not use: in or near the eyes over large portions of the body in large quantities particularly over raw surfaces or blistered areas longer than 7 days unless directed by a doctor more than 1 to 3 times daily

📄 Ask a Doctor Before Use If 16 words ▾

Ask a doctor before use if you have serious burns animal bites deep or puncture wounds

📄 Stop Use and Ask a Doctor If 26 words ▾

Stop use and ask a doctor if condition lasts for more than 7 days condition worsens 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

📄 Package Label / Principal Display Panel 26 words ▾

5391 First aid-Burn cream H&B v24f-Small.jpg HB 0351 First Aid & Burn Cream Unit v25Small_Jpeg.jpg HB 0350 First Aid & Burn Cream Unit 10 per v25_Small_Jpeg.jpg

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 HART Health. 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 4 other package presentations of this same product, including 6 packets (50332-0091-01), 10 packets (50332-0091-06), 25 packets (50332-0091-02). 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?
HART Health 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.
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.