Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Aluroderm Scar allantoin .0075 g/g Patch, 5 patches — NDC 84991-0316-1 (Billing 84991-0316-01)
by Olakino Therapeutics LLC · 1 POUCH in 1 BOX / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH
This is a package of 5 patches of Aluroderm Scar allantoin .0075 g/g Patch from Olakino Therapeutics LLC, marketed since Dec 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
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 ↓
Main listing for product 84991-0316 · Also comes in:
5 patches 84991-0316-5
🗂️ FDA directory synced Oct 8, 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 84991-0316-1 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 84991 labeler · 0316 product · 1 package
- Package marketed since
- Dec 24, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 5 EA per package
- Barcode (UPC)
- 0384991031619, 0384997031651
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
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
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
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
Quick answers
- GSN (GCN sequence number): 087320
- GCN: 57205
- HICL (First Databank): 002694
- AHFS class code: 84:92.00.00
- RxCUI (RxNorm): 2711688
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
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.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about allantoin?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 84991-0316-01 You're viewing this Main listing | 1 POUCH in 1 BOX / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH | 2024-12-24 | — | Active |
| 84991-0316-05 84991-0316-5 | 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH | 2024-12-24 | — | Active |
Pack size FAQ
What quantity is in this package?
This package contains 5 patches — 1 pouch in 1 box / 5 patch in 1 pouch / 8.5 g in 1 patch.
How does this package differ from NDC 84991-0316-05?
Both are Aluroderm Scar allantoin .0075 g/g Patch — the drug itself is identical. This page's package is the 5 patches one, 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?
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Oct 3, 2026
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
LabelerOlakino Therapeutics LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code84991
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio2 products on file
More NDCs from Olakino Therapeutics LLC labeler code 84991
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 openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
USES -Scar Management -Temporarily protects and helps relieve chapped or cracked skin
⏱️ Dosage and Administration ▾
DIRECTIONS Adults and Children 12 Years of Age and Older -Clean and dry the affected area -Apply as needed
⚠️ Warnings ▾
WARNINGS FOR EXTERNAL USE ONLY
🧪 Active Ingredient ▾
ACTIVE INGREDIENTS Allantoin 0.75%
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENTS Hyaluronic Acid, Taxifolin, Polyurethane, Sodium Carboxymethyl Cellulose
🎯 Purpose ▾
PURPOSE Skin Protectant
📄 Do Not Use ▾
DO NOT USE -On deep punctures, serious burns, or infected skin
📄 When Using This Product ▾
WHEN USING THIS PRODUCT Avoid contact with the eyes
📄 Stop Use and Ask a Doctor If ▾
STOP USE AND ASK DOCTOR IF -Condition worsens -Excessive skin irritation develops -Condition persists for more than 7 days, or condition clears up and occurs again within 3 days
🤰 If Pregnant or Breast-Feeding ▾
IF PREGNANT OR BREASTFEEDING Consult a physician before use
📄 Keep Out of Reach of Children ▾
KEEP OUT OF REACH OF CHILDREN If ingested, seek medical help or contact Poison Control immediately
📄 Package Label / Principal Display Panel ▾
pouch box
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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 Aluroderm Scar (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 92%
Female · 8%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
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 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.
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.