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 27 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eucerin Eczema Relief Body OATMEAL Beiersdorf Inc 9895f3c3-b00b-462c-ace0-696d688e2e04 2025-12-31 Warnings Exact identifier application number: M016 Eucerin Eczema Relief Flare Up Treatment OATMEAL Beiersdorf Inc a9ea4832-3211-40b2-accf-90ace7b9e279 2025-12-31 Warnings Exact identifier application number: M016 Eczema Relief Cream Body Wash OATMEAL Beiersdorf Inc f12644e5-0ff0-de0e-e053-2995a90a0995 2025-12-31 Warnings Exact identifier application number: M016 XIMONTH Honey Eye Drops GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 4727f304-0bc7-2fee-e063-6394a90a0178 2025-12-30 Warnings Exact identifier application number: M016 Kinfield Relief Balm Anti-Itch Remedy KINFIELD RELIEF BALM ANTI-ITCH REMEDY Kinfield, Inc. bf394192-c789-faff-e053-2995a90a52bc 2025-12-30 Warnings Exact identifier application number: M016 911 ALLANTOIN Skinfix, Inc. f28c251e-a91b-4ed4-8224-b47c345f982f 2025-12-29 Warnings Exact identifier application number: M016 EXTRA STRENGTH BODY COLLOIDAL OATMEAL Skinfix, Inc. 32ba5f29-c037-44dd-b5b1-59001ac50753 2025-12-29 Warnings Exact identifier application number: M016 VITACILINA Bebe Diaper Rash ALLANTOIN, ZINC OXIDE Compania Internacional de Comercio, S.A.P.I de C.V. 39726b59-bd85-4541-80e5-4f2919842dca 2025-12-29 Warnings Exact identifier application number: M016 Creamy Diaper Rash ZINC OXIDE Davion, Inc 0fdfe7d3-e4cd-6bea-e063-6394a90a37f6 2025-12-29 Warnings Exact identifier application number: M016 Medicated Cornstarch Baby Powder ACTIVE CORN STARCH Davion, Inc. e39032d1-c8cd-4a41-af10-126970b8ad38 2025-12-29 Warnings Exact identifier application number: M016 WinCo FoodsPetroleum Jelly WHITE PETROLATUM WinCo Foods, LLC f5dcf0b2-4f9f-023a-e053-2995a90a183a 2025-12-28 Warnings Exact identifier application number: M016 WinCo FoodsPetroleum Jelly WHITE PETROLATUM WinCo Foods, LLC f5dca60a-e9bc-4161-e053-2995a90a2bcb 2025-12-28 Warnings Exact identifier application number: M016 Hydrating Healing HYDRATING HEALING OINTMENT Neilmed Pharmaceuticals Inc., 47106abb-4c39-07d9-e063-6394a90a4fae 2025-12-28 Warnings Exact identifier application number: M016 TCX Skincare COLLOIDAL OATMEAL Theraceutix, LLC c3be950b-28cf-47c2-9570-ebd46e43b1ba 2025-12-24 Warnings Exact identifier application number: M016 Nizoral Eczema Relief Cream COLLOIDAL OATMEAL Kramer Laboratories da3a39d7-197f-4451-9d24-f92adbe0fc19 2025-12-23 Warnings Exact identifier application number: M016 Healing Head to Toe ALLANTOIN The Honest Company, Inc dc02033f-8116-1710-e053-2995a90aff69 2025-12-23 Warnings Exact identifier application number: M016 Honest Eczema Cream COLLOIDAL OATMEAL The Honest Company, Inc. 6f111094-425b-4a8c-b71a-5ff65f4a8000 2025-12-23 Warnings Exact identifier application number: M016 BABY ANTI MONKEY BUTT DIAPER RASH ZINC OXIDE, CALAMINE Clarion Brands, LLC e4424d74-f89c-5943-42e8-bf3a38e68619 2025-12-23 Warnings Exact identifier application number: M016 Dissolvable Microneedle Eye Patches ALLANTOIN Advaccine Biopharmaceuticals Suzhou Co., Ltd 4684fa4e-5c5e-045d-e063-6394a90af069 2025-12-22 Warnings Exact identifier application number: M016 Good Neighbor Petroleum Jelly WHITE PETROLATUM AmerisourceBergen e5fb80a0-cc8c-e9e7-e053-2a95a90a455d 2025-12-22 Warnings Exact identifier application number: M016
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