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Aluroderm Scar allantoin .0075 g/g Patch, 5 patches — NDC 84991-0316-01 package photo

Aluroderm Scar allantoin .0075 g/g Patch, 5 patches

by Olakino Therapeutics LLC · 1 POUCH in 1 BOX (84991-0316-1) / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH
NDC 84991-0316-01
🏷️ FDA NDC (as labeled) 84991-0316-1 billing pads the package segment with a zero
This package
Contains5 patches Pack sizes2 compare ↓
Also comes in: 5 patches 84991-0316-05
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 →

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) 84991-0316-1
Product NDC 84991-0316
11-digit billing NDC 84991031601
NCPDP billing unit EA — each (per item)
RxCUI 2711688
UNII 344S277G0Z
UPC 0384991031619, 0384997031651
Application # M016
SPL Set ID 2a848dde-8fc4-ab10-e063-6294a90a2583
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-24
Route CUTANEOUS
Dosage form PATCH
Substance ALLANTOIN
GCN Seq No 087320
GCN 57205
HICL code 002694
Ingredient (HICL) Allantoin
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L9
Therapeutic class — intermediate (HIC2) Dermatologic Preparations,Miscellaneous
HIC3 code L9A
Therapeutic class — specific (HIC3) Topical Agents,Miscellaneous
AHFS code 84:92.00.00
AHFS class Skin And Mucous Membrane Agents, Misc.
FDB label name ALURODERM 0.75% PATCH
FDB brand name Aluroderm
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 84991-0316-1 — 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 → 84991-0316-01. 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.

🏭 Manufacturer & labeler

LabelerOlakino Therapeutics LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code84991
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio2 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

Label name ALURODERM 0.75% PATCH Ingredient Allantoin
🧪 What is this product?

Aluroderm Scar is a skin patch containing allantoin, an over-the-counter monograph product. Allantoin is commonly used in topical scar and wound-care products because it is thought to support skin healing and smoothing. This patch delivers allantoin directly to the skin where it is applied. The product is marketed as a non-prescription option for people interested in scar appearance management.

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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII J9PXX566KC
    A synthetic plastic polymer used in medicines as a binder or film-forming agent. It helps hold tablet ingredients together or creates a protective coating on the outside of the pill.
  • UNII 9SOB9E3987
    A natural flavonoid compound derived from plants, used as an antioxidant in medicines. It helps protect the drug's active ingredients from degradation during storage and shelf life.

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

The official label also statesHyaluronic Acid, Taxifolin, Polyurethane, Sodium Carboxymethyl Cellulose

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 eachPer 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: 5 patches
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
Aluroderm Scar .0075 g/g 76420-0955-01 Asclemed 5 patches — — FDA listed —
Aluroderm Scar .0075 g/gthis 84991-0316-01 Olakino 5 patches — — 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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
84991-0316-01 You're viewing this 1 POUCH in 1 BOX (84991-0316-1) / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH 2024-12-24 Active
84991-0316-05 5 PATCH in 1 POUCH (84991-0316-5) / 8.5 g in 1 PATCH 2024-12-24 Active

Pack size FAQ

What quantity is in NDC 84991-0316-01?
NDC 84991-0316-01 contains 5 patches — 1 pouch in 1 box / 5 patch in 1 pouch / 8.5 g in 1 patch.
What is the difference between NDC 84991-0316-01 and NDC 84991-0316-05?
Both are Aluroderm Scar allantoin .0075 g/g Patch — the drug itself is identical. NDC 84991-0316-01 is the 5 patches package, while NDC 84991-0316-05 is the 5 patches package.
What NDC number is used to bill for this package of Aluroderm Scar allantoin .0075 g/g Patch?
Bill NDC 84991-0316-01 — the 11-digit billing format is 84991031601. 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 84991-0316-1, 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: 84991-0316-01, written without dashes as 84991031601. 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 84991-0316-01, the first segment (84991) is the labeler code FDA assigned to Olakino Therapeutics LLC; the middle segment (0316) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Olakino Therapeutics 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 5 patches (84991-0316-05). 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?
Olakino Therapeutics 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 12 words ▾

USES -Scar Management -Temporarily protects and helps relieve chapped or cracked skin

⏱️ Dosage and Administration 19 words ▾

DIRECTIONS Adults and Children 12 Years of Age and Older -Clean and dry the affected area -Apply as needed

⚠️ Warnings 5 words ▾

WARNINGS FOR EXTERNAL USE ONLY

🧪 Active Ingredient 4 words ▾

ACTIVE INGREDIENTS Allantoin 0.75%

🧪 Inactive Ingredients 9 words ▾

INACTIVE INGREDIENTS Hyaluronic Acid, Taxifolin, Polyurethane, Sodium Carboxymethyl Cellulose

🎯 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 ↗
← 84991-0208-01 · Olakino 84992-0001-01 · ADP →
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.