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First honey Burn Salve ALLANTOIN 5 mg/mL Cream — NDC 81995-0056-02 package photo

First honey Burn Salve ALLANTOIN 5 mg/mL Cream

by First Honey, LLC · 1 POUCH in 1 CARTON (81995-056-02) / 5 mL in 1 POUCH
NDC 81995-0056-02
🏷️ FDA NDC (as labeled) 81995-056-02 billing pads the product segment with a zero
This package
Contains5 mL in 1 pouch Pack sizes2 compare ↓
Also comes in: 100 mL 81995-0056-01
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 →

🆔 Identity & classification

FDA NDC (as labeled) 81995-056-02
Product NDC 81995-056
11-digit billing NDC 81995005602
RxCUI 241509
UNII 344S277G0Z
Application # M016
SPL Set ID f40a9a34-1827-7171-e053-2a95a90acf31
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-05-10
Route TOPICAL
Dosage form CREAM
Substance ALLANTOIN
Why two NDCs? The FDA registers this code as 81995-056-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 81995-0056-02. 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.

🏭 Manufacturer & labeler

LabelerFirst Honey, LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code81995
First marketedMay 2022
Product typeHuman Otc Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

First Honey Burn Salve is a topical cream containing allantoin, an over-the-counter monograph product. Allantoin is commonly used in skin-care products to help soften and soothe the outer skin layer. This cream is typically applied directly to the skin and is often used for minor skin irritation and wound care.

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.

🧪 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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII UB27587839
    A plant-derived oil from Roman chamomile flowers. It's used in medicines as a flavoring agent and fragrance to improve taste and smell.
  • 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 Y9H1V576FH
    Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
  • UNII A2M91M918C
    A plant-based oil derived from soybeans that has been chemically hardened to make it solid or semi-solid at room temperature. It acts as a binder, filler, and lubricant to help hold the tablet together and allow it to move smoothly during manufacturing and packaging.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII MHT97MG5P8
    Rosa canina seed oil is a plant-based oil extracted from wild rose seeds. It's used in medicines as an emollient and carrier, helping to soften formulations and distribute active ingredients evenly throughout the product.
  • UNII IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • UNII 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • 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.

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

The official label also statesAloe Barbadensis Leaf Juice, Anthemis Nobilis Flower Oil, Argania Spinosa Kernel Oil, Benzyl Alcohol, Caprylic/Capric Triglyceride, Cucumis Sativus Fruit Extract, Ethylhexylglycerin, Helianthus Annuus Extract, Lavandula Angustifolia Oil, Lecithin, Manuka Honey, Mixed Tocopherols, Oryza Sativa Bran Extract, Propanediol, Rosa Canina Seed Oil, Rosmarinus Officinalis Leaf Extract, Sodium Acrylates Copolymer, Soya Bean Oil, Tetrahexyldecyl Ascorbate, Tocopherol, Water (Aqua).

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 DailyMedingredient 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 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: 100 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetaphil Baby Soothe and Protect Cream 5 mg/g 00299-4103-05 Galderma 170 g FDA listed
Cetaphil Soothing Gel Cream 5 mg/g 00299-4105-00 Galderma 10 g FDA listed
Teevodar .5 g/100g 69435-1301-01 PEER 1 tube FDA listed
DeFlame 5 mg/mL 78863-1270-01 Noon 1 tube FDA listed
Drs. pharmacy Scar Cream .5 g/100g 80489-0333-01 OL 1 tube FDA listed
First honey Burn Salve 5 mg/mLthis 81995-0056-02 First 1 pouch FDA listed
Bed Sore and Wound Healing Cream 5 mg/g 85384-0011-01 TAGRID 30 g FDA listed
Advanced Formula Scar Defense Cream .5 g/100g 87512-0002-01 Yantai 20 g FDA listed
Advanced Silicone Scar .5 g/100g 87512-0006-01 Yantai 20 g FDA listed
SkinCeuticals Advanced Scar Control Skin Protectant 5 mg/mL 49967-0783-01 L'Oreal 1 tube FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
81995-0056-01 1 TUBE in 1 CARTON (81995-056-01) / 100 mL in 1 TUBE 2022-05-10 Active
81995-0056-02 You're viewing this 1 POUCH in 1 CARTON (81995-056-02) / 5 mL in 1 POUCH 2023-06-01 Active

Pack size FAQ

What quantity is in NDC 81995-0056-02?
NDC 81995-0056-02 is listed by the FDA — 1 pouch in 1 carton / 5 ml in 1 pouch.
What NDC number is used to bill for this package of First honey Burn Salve ALLANTOIN 5 mg/mL Cream?
Bill NDC 81995-0056-02 — the 11-digit billing format is 81995005602. 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 81995-056-02, 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: 81995-0056-02, written without dashes as 81995005602. 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 81995-0056-02, the first segment (81995) is the labeler code FDA assigned to First Honey, LLC; the middle segment (0056) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 First Honey, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (81995-0056-01). 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?
First Honey, 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.

📄 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 20 words

Uses Temporarily protects minor cuts scrapes burns helps prevent and temporarily protects and helps relieve chafed, chapped, or cracked skin

⏱️ Dosage and Administration 4 words

Directions Apply as needed

⚠️ Warnings 69 words

Warnings For external use only When using product do not get into eyes Stop use and ask a doctor if Conditions worsen Symptoms last more than 7 days or clear up and occur again within a few days Do not use on Deep or puncture wounds Animal bites Serious burns Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

🧪 Active Ingredient 7 words

Active ingredient Allantoin 0.5% Purpose Skin Protectant

🧪 Inactive Ingredients 58 words

Inactive ingredients Aloe Barbadensis Leaf Juice, Anthemis Nobilis Flower Oil, Argania Spinosa Kernel Oil, Benzyl Alcohol, Caprylic/Capric Triglyceride, Cucumis Sativus Fruit Extract, Ethylhexylglycerin, Helianthus Annuus Extract, Lavandula Angustifolia Oil, Lecithin, Manuka Honey, Mixed Tocopherols, Oryza Sativa Bran Extract, Propanediol, Rosa Canina Seed Oil, Rosmarinus Officinalis Leaf Extract, Sodium Acrylates Copolymer, Soya Bean Oil, Tetrahexyldecyl Ascorbate, Tocopherol, Water (Aqua).

🎯 Purpose 3 words

Purpose Skin Protectant

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.