FDA.reportPublic FDA data

Aluroderm Scar

Product NDC
84991-0316
11-digit product format
849910316
Labeler code
84991
Product ID
84991-0316_2d94d970-563c-466c-e063-6294a90a93db
Type
HUMAN OTC DRUG
Nonproprietary name
allantoin
Dosage form
PATCH
Route
CUTANEOUS
Labeler
Olakino Therapeutics LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-24
Substance
ALLANTOIN
Active strength
.0075 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Aluroderm Scar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN.0075 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
344S277G0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2711688Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2a848dde-8fc4-ab10-e063-6294a90a2583Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84991-0316-1Aluroderm Scar5 in 1 POUCHPATCH52
84991-0316-1Aluroderm Scar1 in 1 BOXPATCH12
84991-0316-5Aluroderm Scar5 in 1 POUCHPATCH52
84991-0316-5Aluroderm Scar8.5 g in 1 PATCHPATCH8.52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84991-0316-1EA - Each84991-0316b16dde49-d6b5-4fb3-b54d-a484f7ce4e6212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84991-0316ALURODERM SCAR (ALLANTOIN) PATCH [OLAKINO THERAPEUTICS LLC]2Current NDC, 4 package rows20250210_2a848dde-8fc4-ab10-e063-6294a90a2583.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum Jelly, Lil Drug StorePETROLATUM JELLYLil' Drug Store Products, Inc.5862af40-97e2-d792-e063-6394a90a0f1a2026-08-06WarningsExact identifier
application number: M016
AOAO RAPID ACNE RELIEFSALICYLIC ACID,BENZOYL PEROXIDEGuangzhou Senmai Biotechnology Co.,Ltd.586df874-0f71-ed46-e063-6294a90a0a8e2026-08-06WarningsExact identifier
application number: M016
Dealmed Vitamins A and DWHITE PETROLATUMDealmed Medical Supplies, LLC.d6584809-b438-4b2c-ab37-522e0dbef4702026-08-05WarningsExact identifier
application number: M016
Dealmed Vitamins A and DPETROLATUMDealmed Medical Supplies, LLC.84afe4ae-f9e8-406f-9fbe-f413975f86eb2026-08-05WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMWalgreens1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f52026-08-04WarningsExact identifier
application number: M016
Nail Treatment Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-08-03WarningsExact identifier
application number: M016
PROCUREZINC OXIDETWIN MED, LLCe68ae97e-668e-31c2-e053-2995a90ab4d32026-08-03WarningsExact identifier
application number: M016
PROCURE VITAMIN A AND D Skin ProtectantPETROLATUMTWIN MED, LLCbbbca68e-1b65-49b1-a5fa-ed4da55d05e32026-08-03WarningsExact identifier
application number: M016
procurePETROLATUMTWIN MED, LLC32520d8f-91ee-47a1-9129-bf0746791f4b2026-08-03WarningsExact identifier
application number: M016
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
application number: M016
456 Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.5830fd36-0613-1980-e063-6294a90adfb72026-08-03WarningsExact identifier
application number: M016
Crogooe Skin Relief CreamCOLLOIDAL OATMEALGuangdong Outeli Biotechnology Co., Ltd.57f9b3e8-25d3-2b20-e063-6394a90aaea52026-08-01WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.57c3556a-aad3-3e65-e063-6394a90ab6892026-07-29WarningsExact identifier
application number: M016
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
application number: M016
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
application number: M016
ATTITUDE Baby Leaves Diaper cream - UnscentedZINC OXIDE9055-7588 Quebec Inc. (Attitude)579aa481-f8ec-b263-e063-6394a90a77542026-07-27WarningsExact identifier
application number: M016
Boo Boo Magic Diaper Rash CreamyZINC OXIDEAlboo Brands LLC5114aff8-adde-e610-e063-6294a90a77ea2026-07-27WarningsExact identifier
application number: M016
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
application number: M016
Hello Bello Diaper Rash CreamZINC OXIDETopiderm, Inc.e158ba31-e159-4624-a490-fe70baaf4a392026-07-24WarningsExact identifier
application number: M016
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2711688allantoin 0.75 % Medicated PatchPSN2a848dde-8fc4-ab10-e063-6294a90a25832
2711688allantoin 0.0075 MG/MG Medicated PatchSCD2a848dde-8fc4-ab10-e063-6294a90a25832
2711688allantoin 0.75 % Medicated PatchSY2a848dde-8fc4-ab10-e063-6294a90a25832
2711688allantoin 0.75 % Medicated PatchPSN60656ca1-5218-4595-854e-19f1061def1e1
2711688allantoin 0.0075 MG/MG Medicated PatchSCD60656ca1-5218-4595-854e-19f1061def1e1
2711688allantoin 0.75 % Medicated PatchSY60656ca1-5218-4595-854e-19f1061def1e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84991-0316-1849910316011 POUCH in 1 BOX (84991-0316-1) / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH1 pouch2024-12-24NoNoCurrent
84991-0316-5849910316055 PATCH in 1 POUCH (84991-0316-5) / 8.5 g in 1 PATCH5 patch2024-12-24NoNoCurrent