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 43 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petroleum Jelly	WHITE PETROLATUM JELLY	WALGREENS	1fc9eecd-fd25-827c-e063-6394a90a26a5	2025-03-26	Warnings	Exact identifier application number: M016
Cocoa Butter Petroleum Jelly	WHITE PETROLATUM JELLY	WALGREENS	1fcc9626-6058-e9b3-e063-6394a90ab525	2025-03-26	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	313b08e2-d764-96da-e063-6294a90ab705	2025-03-25	Warnings	Exact identifier application number: M016
Eczema Cream	ECZEMA CREAM	Kyte Baby LLC	30c943aa-d9dc-5c16-e063-6294a90a3c58	2025-03-20	Warnings	Exact identifier application number: M016
Koala Kubs Diaper Rash Cream	DIAPER RASH CREAM	Melaleuca, Inc.	c6b3b0dd-22a8-16f7-e053-2a95a90a51ea	2025-03-20	Warnings	Exact identifier application number: M016
Gold Bond Eczema Relief Medicated Skin Protectant Cream	COLLOIDAL OATMEAL	Chattem, Inc.	2b6b8342-878d-4588-8b24-6746d35d319d	2025-03-19	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	30b20bd5-3b4f-8cc7-e063-6394a90a9106	2025-03-19	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	30b2744d-fb59-f383-e063-6294a90abd2a	2025-03-19	Warnings	Exact identifier application number: M016
Dr. Butler Hemorrhoid and Perineal	MINERAL OIL 59.8%,PETROLATUM 36%	Beyond Health P.A.	d17b6f16-6893-ce0a-e053-2a95a90aa23a	2025-03-19	Warnings	Exact identifier application number: M016
Gold Bond Diabetics Medicated Dry Skin Relief Foot Cream	DIMETHICONE, WHITE PETROLATUM	Chattem, Inc.	b951d1cb-b81e-4d7f-9a67-8405daa89667	2025-03-19	Warnings	Exact identifier application number: M016
Gold Bond Eczema Relief Medicated Hand Cream	COLLOIDAL OATMEAL	Chattem, Inc.	27457bc5-3edc-4c8b-b8a2-eaf09b511cf8	2025-03-19	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	30a977c3-6862-670e-e063-6294a90aeb2f	2025-03-18	Warnings	Exact identifier application number: M016
YVTYVT Copper Peptides Face Serum	COPPER TRIPEPTIDE-1	Beijing JUNGE Technology Co., Ltd.	306f2d48-43b8-359a-e063-6394a90a06dc	2025-03-16	Boxed warning, Warnings	Exact identifier application number: M016
Dr Talbots Cooling Perineal Pad	WATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATE	Talbot's Pharmaceuticals family Products, LLC.	242277e2-ff26-ad4e-e063-6394a90ab317	2025-03-14	Warnings	Exact identifier application number: M016
RID Poison Ivy Rash Relief	CALAMINE AND ZINC OXIDE	Oystershell Consumer Health Inc.	36c3af9a-2646-4427-e063-6394a90a2c5e	2025-03-13	Warnings	Exact identifier application number: M016
Aavini Double Layer Brightening Spot Correcting Essence Oil	AAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OIL	Qingyuan Moksha Biotechnology Co., Ltd.	2ff89a13-3969-2df1-e063-6394a90ac0d3	2025-03-10	Warnings	Exact identifier application number: M016
5% Signature Numb cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	3008bbeb-abba-5cdb-e063-6294a90ae483	2025-03-10	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	2fc4745c-fac9-7861-e063-6294a90a3f14	2025-03-07	Warnings	Exact identifier application number: M016
AD Skin Protectant	AD SKIN PROTECTANT	WellSpring Pharmaceutical Corporation	d26f1312-2e1b-4106-bc48-a336d4e034ad	2025-03-07	Warnings	Exact identifier application number: M016
Aveeno Baby Eczema Therapy Nighttime Balm	OATMEAL	Kenvue Brands LLC	04d90e45-c2ee-4122-b919-a0eb6d11b59a	2025-03-04	Warnings	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