FDA.reportPublic FDA data

Mederma Advanced Scar

Product NDC
73302-201
11-digit product format
733020201
Labeler code
73302
Product ID
73302-201_5916ff73-1d7c-416d-97ad-11038b1b5d2c
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin
Dosage form
GEL
Route
TOPICAL
Labeler
PMI Branded Pharmaceuticals, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-01
Marketing end
2027-08-01
Substance
ALLANTOIN
Active strength
5 mg/g
NDC exclude flag
No
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
Mederma Advanced Scar

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN5 mg/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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1442087Internal RxNorm lookup
1442092Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
25bc1eae-3502-4c63-bd8a-43be2dfb0d6dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73302-201-20Mederma Advanced Scar1 in 1 BOXGEL15
73302-201-20Mederma Advanced Scar20 g in 1 TUBEGEL205
73302-201-50Mederma Advanced Scar50 g in 1 TUBEGEL505
73302-201-50Mederma Advanced Scar1 in 1 BOXGEL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73302-201-20GM - Gram73302-20119fcb90c-62f2-42e7-bf84-6e859b8b1ee112024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73302-201MEDERMA ADVANCED SCAR (ALLANTOIN) GEL [HRA PHARMA AMERICA, INC.]5Current NDC, Legacy NDC, 4 package rows20250129_25bc1eae-3502-4c63-bd8a-43be2dfb0d6d.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
1442087allantoin 0.5 % Topical GelPSN25bc1eae-3502-4c63-bd8a-43be2dfb0d6d5
1442092Mederma Advanced Scar 0.5 % Topical GelPSN25bc1eae-3502-4c63-bd8a-43be2dfb0d6d5
1442092allantoin 0.005 MG/MG Topical Gel [Mederma Advanced Scar]SBD25bc1eae-3502-4c63-bd8a-43be2dfb0d6d5
1442087allantoin 0.005 MG/MG Topical GelSCD25bc1eae-3502-4c63-bd8a-43be2dfb0d6d5
1442087allantoin 0.5 % Topical GelSY25bc1eae-3502-4c63-bd8a-43be2dfb0d6d5
1442092Mederma Advanced Scar 0.005 MG/MG Topical GelSY25bc1eae-3502-4c63-bd8a-43be2dfb0d6d5
1442092Mederma Advanced Scar 0.5 % Topical GelSY25bc1eae-3502-4c63-bd8a-43be2dfb0d6d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73302-201-20733020201201 TUBE in 1 BOX (73302-201-20) / 20 g in 1 TUBE1 tube2013-11-012026-11-01NoNoCurrent
73302-201-50733020201501 TUBE in 1 BOX (73302-201-50) / 50 g in 1 TUBE1 tube2013-11-012027-08-01NoNoCurrent