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 11 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily MoisturizingDIMETHICONEAldi, Inc118a1a07-7283-4353-97b5-6ac3b1cc14302026-05-08Warnings, Adverse reactionsExact identifier
application number: M016
DoveANTIBACTERIAL CARE MOISTURIZING CREAMConopco Inc. d/b/a/ Unilever5150f48c-ff0c-ce39-e063-6394a90ad4242026-05-08WarningsExact identifier
application number: M016
Seedlings Diaper Rash CreamZINC OXIDEYoung Living Essential Oils, LC.4d8aeaba-ddb1-6f74-e054-00144ff88e882026-05-08WarningsExact identifier
application number: M016
Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.5120b708-047a-1182-e063-6394a90a74c32026-05-06WarningsExact identifier
application number: M016
AOAO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.512185a5-5c1d-ef9f-e063-6394a90a81af2026-05-06WarningsExact identifier
application number: M016
AKOLKOL TOENAIL FUNGUS TREATMENTGLYCERINShantou Ximonth Biotechnology Co., Ltd.5121c341-e5e9-2b36-e063-6394a90a93b82026-05-06WarningsExact identifier
application number: M016
Beyond Good Diaper RashZINC OXIDEBabylist, Inc512b62df-4f08-d839-e063-6294a90ab52f2026-05-06WarningsExact identifier
application number: M016
Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.4c531280-bc5b-1cf2-e063-6394a90a034a2026-05-05WarningsExact identifier
application number: M016
PEGO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.511eaced-c4d8-ae94-e063-6394a90a320e2026-05-05WarningsExact identifier
application number: M016
Rugby Gas reliefSIMETHICONERugby Laboratories9b84f74f-8609-489d-b411-3103afa1b5c22026-05-04WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMAldermed Inc.3f13a15c-8b64-48f0-a459-853b9097bc312026-05-04WarningsExact identifier
application number: M016
Zinc Oxide Skin ProtectantZINC OXIDE 20%Aldermed Inc.a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e522026-05-04WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMAldermed Inc.4e02af41-db86-46d8-a97d-332d84eced6f2026-05-04WarningsExact identifier
application number: M016
Daily MoisturizerLOTIONWalgreensfc65f673-b23d-1ffa-e053-6394a90a09662026-05-03WarningsExact identifier
application number: M016
Dry Skin HealingPETROLATUMWalgreen0397507d-4b6e-c679-e063-6294a90a0b332026-05-03WarningsExact identifier
application number: M016
Daily MoisturizerLOTIONWalgreenfc67037a-ed31-f678-e053-6394a90a71752026-05-03WarningsExact identifier
application number: M016
Skin ReliefLOTIONWalgreenfc678e80-e63d-e3fe-e053-6394a90aa7d62026-05-03WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWalmart INCf76ceecc-ef11-3839-e053-6394a90a8d4a2026-05-03WarningsExact identifier
application number: M016
Herpecin LDIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONEFocus Consumer Healthcare, LLC5b6ed4e9-3e69-c773-e053-2991aa0a7dfe2026-05-01WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, 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