FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductEExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage41163-020-26EExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductEExcluded after deficient or non-compliant submission was not corrected86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage41163-020-26EExcluded after deficient or non-compliant submission was not corrected86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductEExcluded after deficient or non-compliant submission was not correctedbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage41163-020-26EExcluded after deficient or non-compliant submission was not correctedbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductEExcluded after deficient or non-compliant submission was not corrected8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage41163-020-26EExcluded after deficient or non-compliant submission was not corrected8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductYUnknown FDA exclusion code: Ye2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage41163-020-26YUnknown FDA exclusion code: Ye2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductYUnknown FDA exclusion code: Y9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage41163-020-26YUnknown FDA exclusion code: Y9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductYUnknown FDA exclusion code: Y110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage41163-020-26YUnknown FDA exclusion code: Y110d247fa046…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
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
244638Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
014d0028-486e-4f1c-a14f-8162e393ebcaAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41163-020-262023-05-17C16284748780-19d75b9cf-f0b3-f424-e053-dadaa90a57ceBaby Basics_Equaline 020.002/020AC-AD Diaper Rash Ointment 40% Zinc Oxide
41163-020-262020-01-31C16284748780-19d75b9cf-f0b3-f424-e053-dadaa90a57ceBaby Basics_Equaline 020.002/020AC-AD Diaper Rash Ointment 40% Zinc Oxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-020-26Diaper Rash1 in 1 CARTONOINTMENT118
41163-020-26Diaper Rash113 g in 1 TUBEOINTMENT11318

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-020-26GM - Gram41163-0204d8548f2-b453-483c-813a-0b63d96bd31212013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC]2
ZINC CATIONACTIVE MOIETY13S1S8SF37DIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC]2
COD LIVER OILINACTIVE INGREDIENTBBL281NWFGDIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC]2
LANOLININACTIVE INGREDIENT7EV65EAW6HDIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UDIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC]2
WATERINACTIVE INGREDIENT059QF0KO0RDIAPER RASH (ZINC OXIDE) PASTE [SUPERVLAU, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-020DIAPER RASH (ZINC OXIDE) OINTMENT [UNITED NATURAL FOODS, INC. DBA UNFI]17Current NDC, 2 package rows20250326_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 58 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
insect bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.006e457d-bfcd-791a-e063-6294a90a8d662024-09-23WarningsExact identifier
application number: M016
daburZINC OXIDEDabur India Limited22cd1e7a-5448-b3f6-e063-6394a90a880d2024-09-23WarningsExact identifier
application number: M016
DABUR Vitamin A and DWHITE PETROLATUMDabur India Limited22cd44ef-4b02-604d-e063-6394a90a7a0a2024-09-23WarningsExact identifier
application number: M016
DABUR ZINC OXIDE 3.8%ZINC OXIDEDabur India Limited2290bbe2-8a88-b94e-e063-6294a90a7e382024-09-20WarningsExact identifier
application number: M016
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLCb34c8e71-7fad-484c-b387-3c424f50b7432024-09-19WarningsExact identifier
application number: M016
Evereden Intensive Eczema BalmCOLLOIDAL OATMEALEden Brands Inc.2243d4ca-5ca4-54d0-e063-6394a90a39402024-09-16WarningsExact identifier
application number: M016
Whipped GelCOLLOIDAL OATMEALOCEAN OLIVE LLC222b381c-665e-177d-e063-6394a90a33062024-09-15WarningsExact identifier
application number: M016
BioBarrier Renewal CreamALLANTOINbluemercury1ee15f84-0561-3cd2-e063-6394a90ab68e2024-09-15WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
application number: M016
Diaper Rash Cream 5.6ozZINC OXIDEChina Ningbo Shangge Cosmetics Technology Corp.21a7c4ce-1360-931c-e063-6294a90aa66d2024-09-11WarningsExact identifier
application number: M016
Healing Cream 3ozPETROLATUMChina Ningbo Shangge Cosmetics Technology Corp.21bdbb13-cc64-b5d7-e063-6294a90ae3fd2024-09-11WarningsExact identifier
application number: M016
Healing Cream15ozPETROLATUMRejoice International Corp.21e4026c-d3da-e4f7-e063-6394a90aabed2024-09-11WarningsExact identifier
application number: M016
Baby Balm Stick 0.65ozPETROLATUM OINTMENTChina Ningbo Shangge Cosmetics Technology Corp.21c0b614-ea19-e98d-e063-6294a90ac44e2024-09-10WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLC65476a2a-8cd4-4477-ac27-9a06f41e47112024-09-09WarningsExact identifier
application number: M016
Diaper Rash Cream 15ozZINC OXIDERejoice International Corp.213213ab-f935-a62e-e063-6394a90af96b2024-09-03WarningsExact identifier
application number: M016
Diaper Rash Cream 5.6ozZINC OXIDERejoice International Corp.2133876b-eaf0-f988-e063-6394a90aae4d2024-09-03WarningsExact identifier
application number: M016
Baby Balm Stick 0.65ozPETROLATUMRejoice International Corp.20cf3bb8-4ab8-2980-e063-6294a90ad6312024-08-29WarningsExact identifier
application number: M016
SUDOCREM SKIN PROTECTANTZINC OXIDELEDA INNOVATIONS USA, INC.20d2cf0b-d237-fd78-e063-6394a90a8d032024-08-29WarningsExact identifier
application number: M016
Healing Cream 3ozPETROLATUMRejoice International Corp.20c9b964-c9af-d63a-e063-6294a90ab9792024-08-28WarningsExact identifier
application number: M016
Babyganics Soothing ItchOATMEALKAS Direct, LLC5c2806fb-5af4-4532-b31a-be77bb23b2772024-08-28WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244638zinc oxide 40 % Topical OintmentPSN014d0028-486e-4f1c-a14f-8162e393ebca18
244638zinc oxide 0.4 MG/MG Topical OintmentSCD014d0028-486e-4f1c-a14f-8162e393ebca18
244638zinc oxide 40 % Topical OintmentSY014d0028-486e-4f1c-a14f-8162e393ebca18
244638ZNO 0.4 MG/MG Topical OintmentSY014d0028-486e-4f1c-a14f-8162e393ebca18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41163-020-26411630020261 TUBE in 1 CARTON (41163-020-26) / 113 g in 1 TUBE1 tube2009-11-18NoNoCurrent