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 20 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diaper RashZINC OXIDETarget Corporation8059f489-f144-4de5-9454-ac6c1af35dd22026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Coconut Milk and Shea Petroleum JellyWHITE PETROLATUMTarget Corporationc78d9864-92e0-4ad8-8a9b-9752ac6784e82026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC043375b2-e636-4822-9e05-df2327d299862026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae2026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMValu Merchandisers Company4113bb6e-070a-4116-a8d6-12c6b4475beb2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEValu Merchandisers Companye5465ddd-e38c-44a4-bb9b-3edbc636576d2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMValu Merchandisers Company8b8decec-e921-4ff9-bb49-7e38e34724f62026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEValu Merchandisers Company0cccadd7-11f3-5d1f-e063-6294a90a55c42026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELValu Merchandisers Company7c6fa37f-79b8-4409-b7a9-3f02332f887a2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEUnited Natural Foods, Inc. dba UNFI014d0028-486e-4f1c-a14f-8162e393ebca2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMUnited Natural Foods, Inc. dba UNFI29a3a719-5e8b-407d-b9d9-bdba267582922026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDETopco Associates LLC8acb1b47-70ed-4aa2-a7c0-e807042affc72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMTopco Associates LLC3babe2cf-9e6c-4f22-940f-c1fdf489f1c72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATETopco Associates LLC8d3d1ff5-4868-495d-807c-e45aa2176f632026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
HealingPETROLATUMTopco Associates LLCb929b159-4af5-4a03-8e7c-676a6ba2bf552026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMTopco Associates LLCcd7f1727-0b6e-4993-9820-43783994efa12026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONETopco Associates LLCf37f17f7-f084-4b74-8361-178d2315a4762026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALTopco Associates LLC4f6af42c-f41e-455f-b94b-3793bf0b9a3f2026-02-13Warnings, Adverse reactionsExact 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