Diaper Rash

Product NDC
37808-020
11-digit product format
378080020
Labeler code
37808
Product ID
37808-020_4b939c72-4f16-dbfa-e063-6294a90a2a8c
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
PASTE
Route
TOPICAL
Labeler
H E B
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-09-10
Substance
ZINC OXIDE
Active strength
400 mg/g
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
Diaper Rash
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE400 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094560Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f0b31d52-2903-487a-aa70-0dbdf4c4d7e7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-020-26Diaper Rash1 in 1 CARTONPASTE118
37808-020-26Diaper Rash113 g in 1 TUBEPASTE11318

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDIAPER RASH (ZINC OXIDE) PASTE [H E B]1
ZINC CATIONACTIVE MOIETY13S1S8SF37DIAPER RASH (ZINC OXIDE) PASTE [H E B]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDIAPER RASH (ZINC OXIDE) PASTE [H E B]1
COD LIVER OILINACTIVE INGREDIENTBBL281NWFGDIAPER RASH (ZINC OXIDE) PASTE [H E B]1
LANOLININACTIVE INGREDIENT7EV65EAW6HDIAPER RASH (ZINC OXIDE) PASTE [H E B]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UDIAPER RASH (ZINC OXIDE) PASTE [H E B]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDIAPER RASH (ZINC OXIDE) PASTE [H E B]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIAPER RASH (ZINC OXIDE) PASTE [H E B]1
WATERINACTIVE INGREDIENT059QF0KO0RDIAPER RASH (ZINC OXIDE) PASTE [H E B]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-020DIAPER RASH (ZINC OXIDE) PASTE [H E B]16Current NDC, Legacy NDC, 2 package rows20250402_f0b31d52-2903-487a-aa70-0dbdf4c4d7e7.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 53 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vitamin A DPETROLATUMDynarex Corporation62ad33f6-46e6-435f-9a5f-e116c3e218bf2024-11-20WarningsExact identifier
application number: M016
Desitin Maximum Strength Diaper RashZINC OXIDEKenvue Brands LLCaf64fc2f-c027-4a68-b368-ee06744a24522024-11-15WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1d5f0207-26f9-2b19-e063-6294a90a64682024-11-14WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC59728810-4ea9-45a1-b945-5a54199e01f32024-11-14WarningsExact identifier
application number: M016
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLCafa1ba48-b504-4af0-a9c7-cd2c9a2e6e592024-11-13WarningsExact identifier
application number: M016
70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORTS USA LLC26cbc1af-a38f-146b-e063-6394a90a716c2024-11-13WarningsExact identifier
application number: M016
VITAMIN A and DVITAMIN A AND DALLIED TRADE LINK LLC26d426c3-4dfb-c984-e063-6394a90a37932024-11-13WarningsExact identifier
application number: M016
ZO Skin Health Post Procedure ProgramALUMINUM ACETATEZO Skin Health, Inc.9786acc8-06ae-4f2b-9602-b7e8c3baeca52024-11-12WarningsExact identifier
application number: M016
DUKAL WHITE PETROLATUMPETROLATUMDukal LLC0c6474ed-2343-d5f2-e063-6394a90a30b32024-11-12WarningsExact identifier
application number: M016
CVS Health Advanced Scar GelADVANCED SCAR GELCVS Health2fead2d8-b645-4d45-8e5b-b4f1da4e5a252024-11-12WarningsExact identifier
application number: M016
CVS Health Advanced Scar GelADVANCED SCAR GELCVS Healthc6926594-ad4e-4937-bda2-9311219a88812024-11-12WarningsExact identifier
application number: M016
CVS Zinc OxideZINC OXIDECVS Healthd67533b1-ae3f-4c9a-a6c9-a742290c90e92024-11-11WarningsExact identifier
application number: M016
CVS Eczema Relief Skin ProtectantOATMEALCVS Health3cf25c43-592f-41cb-aa0b-a82f4e7faf3d2024-11-11WarningsExact identifier
application number: M016
DGH Advanced Formula Scar Skin ProtectantALLANTOINDolgencorp Inc950dcffd-d2c3-4ca7-8a15-7cb1016ca3642024-11-08WarningsExact identifier
application number: M016
ABC Arbonne Baby Care Diaper RashDIMETHICONE AND ZINC OXIDEArbonne International, LLCdd1d8198-bb9d-4508-a971-ae3bc624cdd12024-11-08WarningsExact identifier
application number: M016
SUPER SENSITIVE DIAPER RASHZINC OXIDEORGANIC & SUSTAINABLE BEAUTYb0de2a9b-7854-4caf-b7ff-632c1d4a382e2024-11-08WarningsExact identifier
application number: M016
DoveDERMASERIES ECZEMA RELIEF SOOTHING BODY LOTIONConopco, Inc. d/b/a/ Unileverbcfb12ea-304e-7d8c-e053-2a95a90af6062024-11-07WarningsExact identifier
application number: M016
VaselineCLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAMConopco, Inc. d/b/a/ Unileverbd206830-e334-3764-e053-2995a90a74ca2024-11-07WarningsExact identifier
application number: M016
DoveMEN SKIN DEFENSE ANTIBACTERIAL 3N1 HAND BODY SHAVE BARConopco Inc. d/b/a/ Unileverb9e61a03-e000-50ab-e053-2a95a90a32102024-11-07WarningsExact identifier
application number: M016
DoveDOVE CARE AND PROTECT ANTIBACTERIAL NOURISHING FOAMING HAND WASHConopco Inc. d/b/a/ Unileverb9f8cb31-560c-79e0-e053-2a95a90a39ae2024-11-07WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094560zinc oxide 40 % Topical PastePSNf0b31d52-2903-487a-aa70-0dbdf4c4d7e718
1094560zinc oxide 0.4 MG/MG PasteSCDf0b31d52-2903-487a-aa70-0dbdf4c4d7e718
1094560zinc oxide 40 % PasteSYf0b31d52-2903-487a-aa70-0dbdf4c4d7e718
1094560ZNO 0.4 MG/MG PasteSYf0b31d52-2903-487a-aa70-0dbdf4c4d7e718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-020-26378080020261 TUBE in 1 CARTON (37808-020-26) / 113 g in 1 TUBE1 tube2010-09-100000-00-00NoNoCurrent