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 12 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herpecin Pain ReliefALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCLFocus Consumer Healthcare, LLCbeeb6043-6547-4fe9-e053-2995a90a5d742026-04-30WarningsExact identifier
application number: M016
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
application number: M016
Dr. NumbLIDOCAINEShinpharma Inc0578fbcb-875a-4606-acde-dcecb29756e62026-04-30WarningsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALAmazon.com Services LLC423c821d-92af-47f0-b9ee-8b68ecbcc44e2026-04-29Warnings, Adverse reactionsExact identifier
application number: M016
MICRO INFUSIONSYSTEMSEEK GLONingbo Kenwei International Trade Co., Ltd.50746cab-bfcc-fe0b-e063-6394a90adc012026-04-27WarningsExact identifier
application number: M016
Pharmacy ChoiceMENTHOL, ZINC OXIDEPHARMACY CHOICE INC5031fc05-e1c7-40b1-e063-6394a90aa12c2026-04-24WarningsExact identifier
application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTIONSEL PH BABY PH-BALANCED ECZEMA DRYNESS BABYGuangzhou Ariel Biotech Co., Ltd.5040b707-87af-3859-e063-6294a90afb3d2026-04-24WarningsExact identifier
application number: M016
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
application number: M016
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
application number: M016
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
application number: M016
Anti-Itch Regular StrengthHYDROCORTISONECVS Pharmacy9fe7768b-9023-c9ee-e053-2a95a90a55b32026-04-17WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONPharma Nobis, LLC4f853183-5925-2c73-e063-6394a90adf6c2026-04-15WarningsExact identifier
application number: M016
Freskaro Calamine PlusZINC OXIDE LOTIONPharma Nobis, LLC4f85bdc7-8fed-f1f5-e063-6394a90a63582026-04-15WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDynarex Corporation11d79dd6-35f7-4399-e063-6294a90ac7dd2026-04-13WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f261746-37e9-7b30-e063-6294a90a92242026-04-10WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f268501-6cd7-7edd-e063-6294a90ac6492026-04-10WarningsExact identifier
application number: M016
BEVERLY HILLS MD HYDRARESCUE TREATMENTDIMETHICONEBeverly Hills MD, LLC4ed33a43-d059-2589-e063-6294a90a30b32026-04-09WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWAL-MART STORES INC00faa772-53f3-9276-e063-6394a90a2dab2026-04-07WarningsExact identifier
application number: M016
ProCure Zinc OxideZINC OXIDETwin Med LLC37a30ee5-fd33-b410-e063-6294a90aef722026-04-07WarningsExact 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