FDA.reportPublic FDA data

Aluroderm Scar

Product NDC
76420-955
11-digit product format
764200955
Labeler code
76420
Product ID
76420-955_31b18752-52bd-1354-e063-6394a90a31f1
Type
HUMAN OTC DRUG
Nonproprietary name
allantoin
Dosage form
PATCH
Route
CUTANEOUS
Labeler
Asclemed USA, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-01
Substance
ALLANTOIN
Active strength
.0075 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

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
60656ca1-5218-4595-854e-19f1061def1eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-955-01Aluroderm Scar1 in 1 BOXPATCH11
76420-955-01Aluroderm Scar5 in 1 POUCHPATCH51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-955ALURODERM SCAR (ALLANTOIN) PATCH [ASCLEMED USA, INC.]1Current NDC, 2 package rows20250403_60656ca1-5218-4595-854e-19f1061def1e.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 10 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EELHOE Cuticle Pusher PenGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.52c7f956-a2a1-ae1d-e063-6294a90ab3c22026-05-27WarningsExact identifier
application number: M016
Dermoia Eczema Relief Colloidal OatmealOATMEALTreasurewise LLC1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a2026-05-27WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWal-Mart Stores, Inc.61e76e2a-fc46-7a64-e053-2991aa0a56a82026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEWal-Mart Stores, Inc.61929c97-bd6b-0d7c-e053-2991aa0aa5712026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
application number: M016
Humco CalamineCALAMINE 8% AND ZINC OXIDE 8%Humco holding Group, Inc.f7dcd959-fb98-43bb-8dd3-a662bf8a053c2026-05-26WarningsExact identifier
application number: M016
Advanced HealingPETROLATUMCVS Pharamacy, Inc0bd3380e-2284-44a7-b2ef-68c9909627fd2026-05-26Warnings, Adverse reactionsExact identifier
application number: M016
CeraVe Developed with Dermatologists Healing Lip BalmPETROLATUML'Oreal USA Products Inc21dc8842-0672-4d46-bcea-b8e3d54c48bf2026-05-20WarningsExact identifier
application number: M016
AFTER CAREDIMETHICONEMerz North Americac19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae2026-05-20WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA63b551fc-7d16-c099-e053-2a91aa0a5f2c2026-05-18WarningsExact identifier
application number: M016
ADVANCED SILICONE SCARALLANTOINYantai Aien Biotechnology Co., Ltd.51ffdc45-5acf-ae20-e063-6294a90a55e82026-05-17WarningsExact identifier
application number: M016
LCFateLC Nail LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.51ea23f4-0a23-4ae1-e063-6394a90aa0512026-05-16WarningsExact identifier
application number: M016
Radlive Active Defense Nano-Silver CreamCOLLOIDAL OATMEALSilverCeuticals51e23135-008d-9db5-e063-6294a90a7d612026-05-15WarningsExact identifier
application number: M016
Cerave Developed with Dermatologists HealingPETROLATUMLOreal USA Products Incde44ac01-ba17-4f97-ac12-9ea348013bde2026-05-14WarningsExact identifier
application number: M016
Triple 3x Max Diaper RashZINC OXIDEAdvantice Health, LLCe554046b-cd0a-4a6e-8f24-2e610c6974322026-05-14WarningsExact identifier
application number: M016
Eczema TherapyCOLLOIDAL OATMEALSilverCeuticals3a26a35e-a098-0e22-e063-6294a90a96b92026-05-13WarningsExact identifier
application number: M016
Nail- PflasterGLYCERINShantou Ximonth Biotechnology Co., Ltd.519681bc-6312-f627-e063-6394a90a28452026-05-11WarningsExact identifier
application number: M016
HydratingPETROLATUMAldermed Inc.4aa6a354-e487-4b65-e063-6394a90abbf02026-05-09WarningsExact identifier
application number: M016
Diaper RashZINC OXIDEAldermed Inc.4aa79292-dc91-b538-e063-6294a90ac3f02026-05-09WarningsExact identifier
application number: M016
XIMONTH Nail Fungus Care LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.514a998d-aa2a-46b6-e063-6294a90a6c222026-05-08WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
76420-955-01764200955011 POUCH in 1 BOX (76420-955-01) / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH1 pouch2025-04-01NoNoCurrent