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 64 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Itch Relief	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	CVS Pharmacy	c60cfbf2-6788-43dc-b23a-e3433b7f3265	2023-12-20	Warnings	Exact identifier application number: M016
Sunmark Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Strategic Sourcing Services LLC	c7467f21-56cc-43ca-abfa-e62d35c8baa6	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	08c00c1a-7ec8-4624-9db0-a0e8430cd126	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Caldyphen Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services LLC	329cd4ef-b699-46ff-a5d6-907f7c327c03	2023-12-19	Warnings	Exact identifier application number: M016
DDM Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Discount Drug Mart	5d536077-b5c6-29b8-e053-2a91aa0a9ae1	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Phenolated Calamine	CALAMINE AND ZINC OXIDE AND PHENOL	Strategic Sourcing Services LLC	8e68efc4-4c95-41c0-9fed-32297b1b2edc	2023-12-19	Warnings	Exact identifier application number: M016
Calm and Heal Melting Balm	ALLANTOIN	The Honest Company, Inc.	b08a1bd6-986d-9520-e053-2995a90a865e	2023-12-19	Warnings	Exact identifier application number: M016
TopCare Calagesic	CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION	TOPCO ASSOCIATES LLC	8dced3ea-147b-3d46-e053-2a95a90aa1c0	2023-12-18	Warnings	Exact identifier application number: M016
TopCare Calamine	CALAMINE 8% AND ZINC OXIDE 8% LOTION	TOPCO ASSOCIATES LLC	8dcf134e-0427-0c43-e053-2995a90a7c26	2023-12-18	Warnings	Exact identifier application number: M016
HEB Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	H E B	5d576794-88d1-484a-e053-2991aa0aa479	2023-12-18	Warnings	Exact identifier application number: M016
Publix Calamine Medicated	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Publix	5d6ba4cf-f2cb-0ecb-e053-2991aa0a5673	2023-12-18	Warnings	Exact identifier application number: M016
TopCare Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	TOPCO ASSOCIATES LLC	8dce8817-b905-4064-e053-2995a90a071e	2023-12-18	Warnings	Exact identifier application number: M016
Assured Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Greenbriar International	9d378cc5-9af0-1389-e053-2995a90a0b96	2023-12-18	Warnings	Exact identifier application number: M016
HEB Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	H E B	5d579680-6bcb-1161-e053-2991aa0aead1	2023-12-18	Warnings	Exact identifier application number: M016
Publix Clear Anti-Itch	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Publix	5d6b905f-ed30-1ab7-e053-2a91aa0a816b	2023-12-18	Warnings	Exact identifier application number: M016
Humco Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Humco Holding Group, Inc.	5fca3a73-6d66-496b-bd33-6e044f9039bc	2023-12-15	Warnings	Exact identifier application number: M016
Calamine Phenolated Topical Suspension	CALAMINE AND ZINC OXIDE AND PHENOL	Humco Holding Group, Inc	a3816729-be2b-4b4f-a609-953576cd2e3b	2023-12-15	Warnings	Exact identifier application number: M016
Humco Mineral Oil Light	MINERAL OIL	Humco Holding Group, Inc.	753f35c3-1420-4817-ba63-b737a9c99a1d	2023-12-15	Warnings	Exact identifier application number: M016
Humco Witch Hazel	WITCH HAZEL	Humco Holding Group, Inc.	3cf07016-a129-49ca-8fad-b67dda5aa009	2023-12-15	Warnings	Exact identifier application number: M016
Rite Aid Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Rite Aid Corporation	5df71189-9b36-9dee-e053-2a91aa0a9e49	2023-12-15	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	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