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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
014d0028-486e-4f1c-a14f-8162e393ebca	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
41163-020-26	2023-05-17	C162847	48780-1	9d75b9cf-f0b3-f424-e053-dadaa90a57ce	Baby Basics_Equaline 020.002/020AC-AD Diaper Rash Ointment 40% Zinc Oxide
41163-020-26	2020-01-31	C162847	48780-1	9d75b9cf-f0b3-f424-e053-dadaa90a57ce	Baby Basics_Equaline 020.002/020AC-AD Diaper Rash Ointment 40% Zinc Oxide

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41163-020-26	GM - Gram	41163-020	4d8548f2-b453-483c-813a-0b63d96bd312	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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 18 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Skin Mercy Recovery Cream	COLLOIDAL OATMEAL	Cultskin Apothecary, Inc.	4bac19f3-13bb-8d18-e063-6394a90aa393	2026-02-25	Warnings	Exact identifier application number: M016
Skin Mercy Intense Recovery Cream	COLLOIDAL OATMEAL	Cultskin Apothecary, Inc.	468f21c6-2d6f-1654-e063-6394a90ab2f5	2026-02-25	Warnings	Exact identifier application number: M016
Magnet Eye Sheet Mask	EYE MASK	Guangdong Bisutang Biotechnology Co., LTD	4a0a84d4-4024-5ea7-e063-6394a90a2b6c	2026-02-24	Warnings	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Family Dollar Stores, Inc	ac7da793-8a39-4b47-b075-a4c4820cadad	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Family Dollar Stores, Inc	1a03331e-3676-451c-be22-9a547e8ae6e2	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Family Dollar Stores, Inc	7e64a424-afdb-4eb9-b6af-7b8123f1e207	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	H E B	e6154e44-d7b2-429c-9bc7-5c064220d3fb	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	H E B	f0b31d52-2903-487a-aa70-0dbdf4c4d7e7	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	H E B	ff79e42c-da3f-4aec-acf4-cc26e10a1d08	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Dimethicone	DIMETHICONE	H E B	a8ad595a-c811-4534-82e0-9a01085b4b1e	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	H E B	ce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	H E B	460802cc-c1b9-41cb-afe3-ca4078175efb	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	H E B	2dd85211-0840-4d0d-8ba7-ea6184a50942	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Meijer, Inc.	12867b23-b203-4bd7-af6d-efddeead26be	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	Meijer, Inc.	c7a4b7f2-4de9-470c-9f5b-0142bd935137	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Better Living Brands, LLC	75cb8f17-6ef2-403e-ab6e-d8e1e8168ec8	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M016
WHITE PETROLATUM	PETROLATUM	Sion Biotext Medical Ltd	53ca3aeb-1d5d-4964-adb5-1cfa901642da	2026-02-23	Warnings	Exact identifier application number: M016
Clear Anti Itch	PRAMOXINE HCL, ZINC ACETATE	Better Living Brands, LLC	1d491635-9605-44fa-9860-ea23e4e8b21c	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Better Living Brands, LLC	ba50f2b2-aff8-42cd-8af0-369060a901fb	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M016
Oatmeal	DIMETHICONE	Better Living Brands, LLC	d28c5a60-0597-424f-bf7f-08dca39b22f5	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
244638	zinc oxide 40 % Topical Ointment	PSN	014d0028-486e-4f1c-a14f-8162e393ebca	18
244638	zinc oxide 0.4 MG/MG Topical Ointment	SCD	014d0028-486e-4f1c-a14f-8162e393ebca	18
244638	zinc oxide 40 % Topical Ointment	SY	014d0028-486e-4f1c-a14f-8162e393ebca	18
244638	ZNO 0.4 MG/MG Topical Ointment	SY	014d0028-486e-4f1c-a14f-8162e393ebca	18

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baby Basics_Equaline 020.002/020AC-AD Diaper Rash Ointment 40% Zinc Oxide	United Natural Foods, Inc. dba UNFI \| Nice-Pak Products, LLC	2026-02-16	HUMAN OTC DRUG LABEL	18