Home NDC 41163-020 Diaper Rash
Product NDC 41163-020
11-digit product format 411630020
Labeler code 41163
Product ID 41163-020_4af6abd5-a79e-6e51-e063-6294a90afdfd
Type HUMAN OTC DRUG
Nonproprietary name Zinc oxide
Dosage form OINTMENT
Route TOPICAL
Labeler United Natural Foods, Inc. dba UNFI
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-11-18
Substance ZINC OXIDE
Active strength 400 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product E Excluded after deficient or non-compliant submission was not corrected fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 41163-020-26 E Excluded after deficient or non-compliant submission was not corrected fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product E Excluded after deficient or non-compliant submission was not corrected 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 41163-020-26 E Excluded after deficient or non-compliant submission was not corrected 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product E Excluded after deficient or non-compliant submission was not corrected bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 41163-020-26 E Excluded after deficient or non-compliant submission was not corrected bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product E Excluded after deficient or non-compliant submission was not corrected 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 41163-020-26 E Excluded after deficient or non-compliant submission was not corrected 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product Y Unknown FDA exclusion code: Y e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 41163-020-26 Y Unknown FDA exclusion code: Y e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product Y Unknown FDA exclusion code: Y 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 41163-020-26 Y Unknown FDA exclusion code: Y 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product Y Unknown FDA exclusion code: Y 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 41163-020-26 Y Unknown FDA exclusion code: Y 110d247fa046…a55b01930146…
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 Ingredient Strength ZINC OXIDE 400 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 244638 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41163-020-26 Diaper Rash 1 in 1 CARTON OINTMENT 1 18 41163-020-26 Diaper Rash 113 g in 1 TUBE OINTMENT 113 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z DIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC] 2 ZINC CATION ACTIVE MOIETY 13S1S8SF37 DIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U DIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC] 2 COD LIVER OIL INACTIVE INGREDIENT BBL281NWFG DIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC] 2 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H DIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC] 2 petrolatum INACTIVE INGREDIENT 4T6H12BN9U DIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC] 2 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T DIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U DIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-020 DIAPER RASH (ZINC OXIDE) OINTMENT [UNITED NATURAL FOODS, INC. DBA UNFI] 17 Current NDC, 2 package rows 20250326_014d0028-486e-4f1c-a14f-8162e393ebca.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 39 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 41163-020-26 41163002026 1 TUBE in 1 CARTON (41163-020-26) / 113 g in 1 TUBE 1 tube 2009-11-18 No No Current