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 6 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mederma PM DIMETHICONE PMI Branded Pharmaceuticals, Inc. 26737285-f6ae-47eb-9019-33f1cfce3029 2026-07-15 Warnings Exact identifier application number: M016 MEDERMA STRETCH MARKS THERAPY DIMETHICONE L. Perrigo Company e9366775-e85b-4403-a2c5-12d9fb3cc3fa 2026-07-15 Warnings Exact identifier application number: M016 Remedy Barrier Cream Cloths Fragrance Free DIMETHICONE Medline Industries, LP 00e0cd4a-6049-408a-ab3f-9edf97e6438a 2026-07-14 Warnings Exact identifier application number: M016 Cruex Petroleum Jelly WHITE PETROLATUM MKJ BRANDS LLC 3e61191a-e0fa-3477-e063-6294a90a7d19 2026-07-14 Warnings Exact identifier application number: M016 Cruex Petroleum Jelly WHITE PETROLATUM MKJ BRANDS LLC 459a90b8-7d52-ef70-e063-6394a90ac1d0 2026-07-14 Warnings Exact identifier application number: M016 Mederma for Kids ALLANTOIN L. Perrigo Company ed4ff435-9819-46d3-9375-914712943f77 2026-07-14 Warnings Exact identifier application number: M016 Baby 3-in-1 Diaper Rash BABY 3-IN-1 DIAPER RASH Walgreens 5632dde2-f59d-3a45-e063-6394a90a1a24 2026-07-09 Warnings Exact identifier application number: M016 Drs. DIAPER RASH MAXIMUM STRENGTH ZINC OXIDE OL PHARMA TECH, LLC Drs PHARMACY 161ba174-1b13-83cd-e063-6394a90af19c 2026-07-09 Warnings Exact identifier application number: M016 Drs. Hydrocortisone Aloe Vera HYDROCORTISONE OL PHARMA TECH,LLC 0df06415-5d32-7ef8-e063-6294a90a6e5a 2026-07-09 Warnings Exact identifier application number: M016 SOHEJU Nail Repairs Patches GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 560089ff-3361-90b7-e063-6294a90ada42 2026-07-09 Warnings Exact identifier application number: M016 Bee Venom Psoriasis Wart Caring Cream GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 563a423c-e9dd-1cab-e063-6294a90a8c6a 2026-07-09 Warnings Exact identifier application number: M016 Skin Protectant with Lanolin LANOLIN McKesson Medical-Surgical Inc. 46df52c8-0cbf-213e-e054-00144ff88e88 2026-07-08 Warnings Exact identifier application number: M016 Skin Protectant with Lanolin LANOLIN McKesson 5abe1b34-f71b-2a90-e053-2991aa0aded6 2026-07-08 Warnings Exact identifier application number: M016 Walgreens Baby Healing Balm PETROLATUM Walgreens 561c1e1e-e896-d6e9-e063-6394a90ac0e7 2026-07-08 Warnings Exact identifier application number: M016 AD Overnight Healing AD OVERNIGHT HEALING WellSpring Pharmaceutical Corporation 57c29db6-da0c-4b28-86c0-6ac1b7122428 2026-07-07 Warnings Exact identifier application number: M016 EczeNourish Eczema and Psoriasis Soothing Oat COLLOIDAL OATMEAL Vanguard Soap, LLC 55f7137f-c5a5-f2ce-e063-6394a90a5280 2026-07-07 Warnings Exact identifier application number: M016 FDS intimate Whole Body Medicated Chafing FDS INTIMATE WHOLE BODY MEDICATED CHAFING WellSpring Pharmaceutical Corporation ef01fcd8-2fe4-4076-a4d4-e730a5c2b31c 2026-07-07 Warnings Exact identifier application number: M016 AD First Aid Multipurpose AD FIRST AID MULTIPURPOSE WellSpring Pharmaceutical Corporation 999989d8-21c2-4380-b4c1-e5421189f6ed 2026-07-07 Warnings Exact identifier application number: M016 AD Anti-Chafing AD ANTI-CHAFING WellSpring Pharmaceutical Corporation d272ab4a-eb18-4f64-b925-fccf637dbb02 2026-07-06 Warnings Exact identifier application number: M016 ECZEMA NOURISH MEDICATED CLEANSING BAR COLLOIDAL OATMEAL SKIN PROTECTANT Vanguard Soap, LLC 55f865dc-d88e-fe2f-e063-6294a90aa7d3 2026-07-06 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