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DeFlame ALLANTOIN 5 mg/mL Cream — NDC 78863-1270-03 package photo

DeFlame ALLANTOIN 5 mg/mL Cream

by Noon Aesthetics M.R. Ltd · 1 BOTTLE, PUMP in 1 CARTON (78863-1270-3) / 150 mL in 1 BOTTLE, PUMP
NDC 78863-1270-03
🏷️ FDA NDC (as labeled) 78863-1270-3 billing pads the package segment with a zero
This package
Contains150 mL in 1 bottle, pump Pack sizes3 compare ↓
Also comes in: 50 mL 78863-1270-01 15 mL 78863-1270-02
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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

🆔 Identity & classification

FDA NDC (as labeled) 78863-1270-3
Product NDC 78863-1270
11-digit billing NDC 78863127003
RxCUI 241509
UNII 344S277G0Z
Application # M020
SPL Set ID 2628bd73-0ca9-497b-bcd9-088444cd62be
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-01
Route TOPICAL
Dosage form CREAM
Substance ALLANTOIN
Why two NDCs? The FDA registers this code as 78863-1270-3 — 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 → 78863-1270-03. 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.

🏭 Manufacturer & labeler

LabelerNoon Aesthetics M.R. Ltd
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code78863
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio21 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

🧪 What is this product?

DeFlame Allantoin 5 mg/mL Cream is a topical OTC monograph product that contains allantoin as its active ingredient. Allantoin is commonly included in creams and ointments applied to skin to help promote moisturizing and soothing of minor skin irritation. This product is marketed as an over-the-counter medication following FDA's established monograph rules for its drug category rather than as an individually approved application.

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.

🧪 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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 01J18G9G97
    Acetyl glutamine is an amino acid derivative made by attaching an acetyl group to the amino acid glutamine. It may be used as a buffering agent, pH regulator, or stability enhancer in pharmaceutical formulations.
  • UNII OZ0E5Y15PZ
    A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
  • UNII S3529G9M9V
    A protein naturally produced by human cells that promotes tissue growth and healing. In medicines, it serves as an active biological component to stimulate cell repair and regeneration at wound or tissue sites.
  • 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 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 9H4PO4Z4FT
    A sulfur-containing organic compound used as a solvent and penetration enhancer in medicines. It helps dissolve active ingredients and improve their absorption through skin or mucous membranes.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII G53298VN9Y
    A protein naturally found in the body that promotes cell growth and tissue repair. In medicines, it serves as the active therapeutic ingredient rather than an inactive filler or binder.
  • 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 CA2Y0FE3FX
    A salt derived from licorice root extract, used as a flavoring agent and sweetener. It may also help soothe and protect mucous membranes in throat lozenges and cough products.
  • UNII NZN256ZSV8
    A protein naturally produced by human cells that promotes blood vessel growth. It is included in some medicines to help improve blood flow and tissue healing in treated areas.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 6HQ855798J
    Laureth-4 is a synthetic detergent made from lauryl alcohol and ethylene oxide. It acts as an emulsifier and solubilizer, helping blend oil and water-based ingredients and improve how the body absorbs the active drug.
  • UNII 7GR9I2683O
    Mecasermin is a human insulin-like growth factor used as an active pharmaceutical ingredient in certain medicines for growth disorders. Note: This is a therapeutic agent, not a traditional inactive excipient, so it serves a primary medicinal role rather than a supporting formulation function.
  • UNII TZK30RF92W
    A lab-made protein fragment containing a few linked amino acids. It's used in formulations as a skin-conditioning agent or penetration enhancer to help other ingredients work effectively.
  • UNII 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII 8Z6VNR46QM
    A synthetic surfactant derived from plant-based materials. It helps dissolve or suspend active ingredients and improves how the medicine spreads on skin or is absorbed in the body.
  • UNII 9713Q0S7FO
    A synthetic emulsifier derived from polyethylene glycol and fatty acids. It helps blend water and oil-based ingredients together in the formulation, improving texture and stability.
  • UNII ECU18C66Q7
    PEG-40 stearate is a synthetic compound made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and solubilizer to help mix oil and water-based ingredients together and improve how the medicine dissolves and is absorbed.
  • 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 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII K2P8K2558N
    A red marine microalga used as a natural colorant in medications and supplements. It provides red to purple coloring to tablets, capsules, and other formulations.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • 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 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 6LUM696811
    A waxy substance derived from sorbitol and stearic acid. It acts as an emulsifier and stabilizer to help mix oil and water components evenly throughout the medicine and prevent separation.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII O09USB7Z44
    Strontium chloride hexahydrate is a mineral salt containing strontium. It's used in some medicines as a source of strontium or as a buffering agent to help maintain the product's pH and stability.
  • 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.

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

The official label also statesAqua, Propylene Glycol, Glycerin, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Polydimethylsiloxane, Cetyl Alcohol, Glyceryl Stearate, Propanediol, Dipotassium Glycyrrhizate, Polysorbate 20, PEG-40 Stearate, Laureth-4, Porphyridium Polysaccharide, Arnica Montana Flower Extract, sh-Oligopeptide-1 (EGF), sh-Oligopeptide-2 (IGF-1), sh-Polypeptide-1 (bFGF), sh-Polypeptide-9 (VEGF), sh-Polypeptide-11 (FGF-1), Bacillus/Folic Acid Ferment Filtrate Extract, Octyldodecyl Xyloside, Butylene Glycol, Sodium Hyaluronate, 1,2-Hexanediol, Acetyl Glutamine, Octyldodecanol, PEG-30 Dipolyhydroxystearate, Sorbitan Tristearate, Lecithin, Phenoxyethanol, Benzyl Alcohol, Caprylyl Glycol, Potassium Sorbate, Disodium EDTA, Sodium Benzoate.

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 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: 50 mL 15 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/mLthis 78863-1270-03 Noon 1 bottle — — FDA listed —
Drs. pharmacy Scar Cream .5 g/100g 80489-0333-01 OL 1 tube — — FDA listed —
First honey Burn Salve 5 mg/mL 81995-0056-01 First 1 tube — — 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

🏛️
2023
On the market since
Oct 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.

🔬 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 ALLANTOIN — the ingredient across all brands.

Top reported reactions

Nausea410
Vomiting289
Condition Aggravated238
Dyspnoea217
Abdominal Pain207
Somnolence196
Fatigue179

Age at onset

Adult14
Elderly52

Reporter sex

3,285 reports
Male · 46%
Female · 53%
Unknown · 0%

Serious outcomes

Hospitalization1,422
Life-threatening345
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 42 0
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 NDCDescription Marketing startStatus
78863-1270-01 1 TUBE in 1 CARTON (78863-1270-1) / 50 mL in 1 TUBE 2023-10-01 Active
78863-1270-02 1 BOTTLE, PUMP in 1 CARTON (78863-1270-2) / 15 mL in 1 BOTTLE, PUMP 2026-07-28 Active
78863-1270-03 You're viewing this 1 BOTTLE, PUMP in 1 CARTON (78863-1270-3) / 150 mL in 1 BOTTLE, PUMP 2026-07-28 Active

Pack size FAQ

What quantity is in NDC 78863-1270-03?
NDC 78863-1270-03 is listed by the FDA — 1 bottle, pump in 1 carton / 150 ml in 1 bottle, pump.
What NDC number is used to bill for this package of DeFlame ALLANTOIN 5 mg/mL Cream?
Bill NDC 78863-1270-03 — the 11-digit billing format is 78863127003. 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 78863-1270-3, 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: 78863-1270-03, written without dashes as 78863127003. 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 78863-1270-03, the first segment (78863) is the labeler code FDA assigned to Noon Aesthetics M.R. Ltd; the middle segment (1270) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Noon Aesthetics M.R. Ltd. 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 1 tube (78863-1270-01), 1 bottle (78863-1270-02). 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?
Noon Aesthetics M.R. Ltd 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 19 words ▾

Uses Temporarily protects minor: skin irritation, cuts, scrapes, burns and helps protect and relieve chafed, chapped or cracked skin.

⏱️ Dosage and Administration 4 words ▾

Directions Apply as needed.

⚠️ Warnings 64 words ▾

Warnings For external use only. Do not use on deep or puncture wounds, animal bites, serious burns. When using this product avoid contact with eyes. In case of eye contact, flush with water. Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children.

🧪 Active Ingredient 4 words ▾

Active Ingredient Allantoin 0.5%

🧪 Inactive Ingredients 71 words ▾

Inactive Ingredients Aqua, Propylene Glycol, Glycerin, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Polydimethylsiloxane, Cetyl Alcohol, Glyceryl Stearate, Propanediol, Dipotassium Glycyrrhizate, Polysorbate 20, PEG-40 Stearate, Laureth-4, Porphyridium Polysaccharide, Arnica Montana Flower Extract, sh-Oligopeptide-1 (EGF), sh-Oligopeptide-2 (IGF-1), sh-Polypeptide-1 (bFGF), sh-Polypeptide-9 (VEGF), sh-Polypeptide-11 (FGF-1), Bacillus/Folic Acid Ferment Filtrate Extract, Octyldodecyl Xyloside, Butylene Glycol, Sodium Hyaluronate, 1,2-Hexanediol, Acetyl Glutamine, Octyldodecanol, PEG-30 Dipolyhydroxystearate, Sorbitan Tristearate, Lecithin, Phenoxyethanol, Benzyl Alcohol, Caprylyl Glycol, Potassium Sorbate, Disodium EDTA, Sodium Benzoate.

🎯 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 ↗
← 78863-1220-02 · Noon 78863-1300-01 · Noon →
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.