FDA.reportPublic FDA data

TriDerma Stubborn Diaper Rash Relief

Product NDC
10738-068
11-digit product format
107380068
Labeler code
10738
Product ID
10738-068_49791622-ff4b-b994-e063-6394a90afab9
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin, Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
Genuine Virgin Aloe Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-31
Substance
ALLANTOIN; DIMETHICONE
Active strength
1.5; 2 g/100g; g/100g
Pharmacologic classes
Skin Barrier Activity [PE]
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
TriDerma Stubborn Diaper Rash Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN1.5 g/100g
DIMETHICONE2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
344S277G0ZInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1927024Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8f3ae0b-aa55-4c2f-8823-54268524917bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
10738-068-202023-02-02TRIDERMA Stubborn Diaper Rash™ Relief Cream
10738-068-402023-02-02TRIDERMA Stubborn Diaper Rash™ Relief Cream
10738-068-502023-02-02TRIDERMA Stubborn Diaper Rash™ Relief Cream
10738-068-202023-01-30TRIDERMA Stubborn Diaper Rash™ Relief Cream
10738-068-402023-01-30TRIDERMA Stubborn Diaper Rash™ Relief Cream
10738-068-502023-01-30TRIDERMA Stubborn Diaper Rash™ Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10738-068-20TriDerma Stubborn Diaper Rash Relief1 in 1 CARTONCREAM15
10738-068-25TriDerma Stubborn Diaper Rash Relief62 g in 1 TUBECREAM625
10738-068-40TriDerma Stubborn Diaper Rash Relief1 in 1 CARTONCREAM15
10738-068-45TriDerma Stubborn Diaper Rash Relief113 g in 1 TUBECREAM1135
10738-068-50TriDerma Stubborn Diaper Rash Relief1 in 1 CARTONCREAM15
10738-068-55TriDerma Stubborn Diaper Rash Relief14 g in 1 TUBECREAM145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10738-068TRIDERMA STUBBORN DIAPER RASH RELIEF (ALLANTOIN, DIMETHICONE) CREAM [GENUINE VIRGIN ALOE CORPORATION]4Current NDC, Legacy NDC, 6 package rows20250101_f8f3ae0b-aa55-4c2f-8823-54268524917b.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 16 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Beauty FAB Ultra Repair Body Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company1a9d86fc-ef32-baed-e063-6394a90a7d742026-03-12WarningsExact identifier
application number: M016
Meijer Scar GelALLANTOIN 0.5%Meijer4c108c34-72f3-1382-e063-6394a90a7f2c2026-03-11WarningsExact identifier
application number: M016
E2 hand washE2 SANITIZING HAND SOAPHorizon Tool Inc.a40afa46-a07d-f864-e053-2a95a90aef8a2026-03-11WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sugar CookieCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4576cd28-9530-4db4-e063-6394a90a9fd32026-03-10WarningsExact identifier
application number: M016
Diaper RashZINC OXIDELidl US, LLCe399b33f-5f7c-47eb-8e9b-1721ae4680b52026-03-10Warnings, Adverse reactionsExact identifier
application number: M016
Vitamin A DWHITE PETROLATUMSion Biotext Medical Ltd.503c4ab9-1f60-48e2-af47-7ef996466a5b2026-03-09WarningsExact identifier
application number: M016
TrstayRETINOL SERUMShenzhen yuehaotong Technology Co.,Ltd4c6e20dd-0a71-a96b-e063-6294a90ab8332026-03-07WarningsExact identifier
application number: M016
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
application number: M016
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c89fc6-016b-d359-e063-6394a90a56022026-03-06WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a2026-03-06WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin ProtectantDIMETHICONEThe Procter & Gamble Manufacturing Company276c68d4-e273-4e48-e063-6294a90ab16f2026-03-04WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4c1d00b3-313b-933f-e063-6294a90ac46f2026-03-03WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEAmazon.com Services LLC495fffd7-7b64-954a-e063-6394a90a81fd2026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLAmazon.com Services LLCaceb0b10-8c90-4a06-8c47-cd1a2b4676a32026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELAmazon.com Services LLC134e07a1-5236-4088-baf9-1ff33126f7932026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEOld East Main Co.7f56ab98-dbd8-412a-8c31-bb6302b7f3292026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMOld East Main Co.ae8583c0-1b52-461d-8506-ec7524f1b4c42026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Healing for BabiesPETROLATUMOld East Main Co.aa1acc24-56af-4708-bf76-23d4de3d089e2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMOld East Main Co.de8d8071-ecb2-4719-8c7b-7944f27810d62026-03-02Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1927024allantoin 1.5 % / dimethicone 2 % Topical CreamPSNf8f3ae0b-aa55-4c2f-8823-54268524917b5
1927024allantoin 15 MG/ML / dimethicone 20 MG/ML Topical CreamSCDf8f3ae0b-aa55-4c2f-8823-54268524917b5
1927024allantoin 1.5 % / dimethicone 2 % Topical CreamSYf8f3ae0b-aa55-4c2f-8823-54268524917b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10738-068-20107380068201 TUBE in 1 CARTON (10738-068-20) / 62 g in 1 TUBE (10738-068-25) 1 tube2019-10-310000-00-00NoNoCurrent
10738-068-251073800682562 g in 1 TUBE62 gHistorical
10738-068-40107380068401 TUBE in 1 CARTON (10738-068-40) / 113 g in 1 TUBE (10738-068-45) 1 tube2019-10-310000-00-00NoNoCurrent
10738-068-4510738006845113 g in 1 TUBE113 gHistorical
10738-068-50107380068501 TUBE in 1 CARTON (10738-068-50) / 14 g in 1 TUBE (10738-068-55) 1 tube2019-10-310000-00-00NoNoCurrent
10738-068-551073800685514 g in 1 TUBE14 gHistorical