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 67 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
calahistCALAMINE AND PRAMOXINE HYDROCHLORIDEWALGREEN COMPANYfed45e06-cc53-fbc5-e053-6294a90a1b192023-10-27WarningsExact identifier
application number: M016
calahist clearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWALGREEN COMPANYfed469c2-fe13-6726-e053-6394a90a5f512023-10-27WarningsExact identifier
application number: M016
Dr. Sayman SalveSALVESheffield Pharmaceuticals LLC18bdcd0c-9c81-47e1-ae24-2239ff8fd0662023-10-24WarningsExact identifier
application number: M016
Theriac Advanced HealingLANOLINSheffield Pharmaceuticals LLCc780cd27-dc9e-45f3-97f0-e59b1b6b955a2023-10-24WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.d66e369e-9b19-b084-e053-2995a90aa2592023-10-23WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby HealingCOLLOIDAL OATMEALBabo Botanicals, Inc.08659a5c-2d10-2f98-e063-6394a90a77602023-10-23WarningsExact identifier
application number: M016
White Rose Petroleum JellyPETROLATUMJ. Strickland & Co.1aeb090d-c103-4c2e-accc-d9d248315db92023-10-21WarningsExact identifier
application number: M016
Tricalm HydrogelALUMINUM ACETATEMODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES082c6441-be47-4466-e063-6394a90ad5002023-10-20WarningsExact identifier
application number: M016
EmpowerWHITE PETROLATUM, ZINC OXIDEBemis Manufacturing Company Inc08006b60-966b-155b-e063-6294a90a206a2023-10-18WarningsExact identifier
application number: M016
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
application number: M016
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
application number: M016
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact 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