Dr. Sheffield Diaper Rash

Product NDC: 11527-058
11-digit product format: 115270058
Labeler code: 11527
Product ID: 11527-058_569610c1-6c56-4437-a651-2004d621d8ac
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Sheffield Pharmaceuticals LLC
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2002-01-09
Substance: ZINC OXIDE
Active strength: 400 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Dr. Sheffield Diaper Rash
Listing expiration: 2026-12-31

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
cac77320-b5cf-4edf-9693-ebabfb61390c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11527-058-40	Dr. Sheffield Diaper Rash	28 g in 1 TUBE	OINTMENT	28	4
11527-058-40	Dr. Sheffield Diaper Rash	1 in 1 CARTON	OINTMENT	1	4
11527-058-41	Dr. Sheffield Diaper Rash	56 g in 1 TUBE	OINTMENT	56	4
11527-058-41	Dr. Sheffield Diaper Rash	1 in 1 CARTON	OINTMENT	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11527-058-41	GM - Gram	11527-058	01e5a460-122f-4378-81d1-b67ba2d5ddb4	1	2021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]	1
COD LIVER OIL	INACTIVE INGREDIENT	BBL281NWFG	DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11527-058	DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS LLC]	4	Current NDC, Legacy NDC, 4 package rows	20231129_cac77320-b5cf-4edf-9693-ebabfb61390c.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	cac77320-b5cf-4edf-9693-ebabfb61390c	4
244638	zinc oxide 0.4 MG/MG Topical Ointment	SCD	cac77320-b5cf-4edf-9693-ebabfb61390c	4
244638	zinc oxide 40 % Topical Ointment	SY	cac77320-b5cf-4edf-9693-ebabfb61390c	4
244638	ZNO 0.4 MG/MG Topical Ointment	SY	cac77320-b5cf-4edf-9693-ebabfb61390c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11527-058-40	11527005840	1 TUBE in 1 CARTON (11527-058-40) / 28 g in 1 TUBE	1 tube	2014-01-17	0000-00-00	No	No	Current
11527-058-41	11527005841	1 TUBE in 1 CARTON (11527-058-41) / 56 g in 1 TUBE	1 tube	2002-01-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dr. Sheffield Diaper Rash - Sheffield Pharmaceuticals LLC	Sheffield Pharmaceuticals LLC	2023-11-28	HUMAN OTC DRUG LABEL	4