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 61 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ChapStick Supreme Classic Cherry	WHITE PETROLATUM	Haleon US Holdings LLC	84d8cc38-83e3-49be-b180-d01820525b60	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Original	AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM	Haleon US Holdings LLC	9cd13fbb-887f-46a8-9f0b-4450ad3e07b7	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Total Hydration Moisture Tint Peachy Keen	ZINC OXIDE	Haleon US Holdings LLC	ef206fe7-2659-41dc-b117-380af704999b	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Total Hydration Moisture Tint Pretty in Pink	ZINC OXIDE	Haleon US Holdings LLC	e686ce23-57bc-4026-be62-d46d90ded442	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Total Hydration Moisture Tint Very Berry	ZINC OXIDE	Haleon US Holdings LLC	59023150-65ef-4427-9045-0e64b100cbab	2024-03-22	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Cool Mint	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Haleon US Holdings LLC	33497c07-ad6e-4c50-bc23-a55725b2eae1	2024-03-21	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Original	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Haleon US Holdings LLC	de250ae9-6e4a-46ca-bcc9-5bb07dbb70c5	2024-03-21	Warnings	Exact identifier application number: M016
ChapStick Classic Strawberry	WHITE PETROLATUM	Haleon US Holdings LLC	3a279496-74c5-4ab1-ba69-06ad4a4f67cf	2024-03-21	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Cool Mint	AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM	Haleon US Holdings LLC	c1120c7a-1fa8-45a4-8bcf-35d9cc9f2c74	2024-03-21	Warnings	Exact identifier application number: M016
terrasil Diabetics Ulcer and Sore Relief Kit	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	523b6598-8039-4116-b0f8-ba31d7d6ea9d	2024-03-20	Warnings	Exact identifier application number: M016
ChapStick Classic Cherry	WHITE PETROLATUM	Haleon US Holdings LLC	db041b1b-084a-4283-b6ba-4d4bcdc220b3	2024-03-19	Warnings	Exact identifier application number: M016
ChapStick Classic Original	WHITE PETROLATUM	Haleon US Holdings LLC	42fe0f4a-efb7-4e70-a359-db7dc2ac9905	2024-03-19	Warnings	Exact identifier application number: M016
ChapStick Classic Spearmint	WHITE PETROLATUM	Haleon US Holdings LLC	74354d8e-c265-4a27-9715-1a4c157ad890	2024-03-19	Warnings	Exact identifier application number: M016
Cetaphil Healing	PETROLATUM	Galderma Laboratories, L.P.	e996db17-bd4d-4b06-bb9a-983dbdec8022	2024-03-13	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2oz	ZINC OXIDE	Rejoice International Corp.	130a06a7-3360-afed-e063-6294a90ac19f	2024-03-06	Warnings	Exact identifier application number: M016
mama bear DIAPER RASH Skin Protectant	LANOLIN AND PETROLATUM	AMAZON.COM SERVICES LLC	cda9ca47-b668-4a65-908d-80b9a6515bd7	2024-03-06	Warnings	Exact identifier application number: M016
Dermachange Scar	ALLANTOIN	Private Label Beauty and Wellness	12eed473-10d6-49c8-e063-6394a90afb63	2024-03-05	Warnings	Exact identifier application number: M016
XtraCare Creamy Petroleum Jelly Cocoa Butter Enriched	PETROLEUM	Rejoice International	580d76ee-ea89-426e-bd25-7a58481e9795	2024-02-28	Warnings	Exact identifier application number: M016
XtraCare Creamy Petroleum Jelly Vitamin E enriched	PETROLATUM	Rejoice International	2c382a50-93d2-4d28-b7a4-1702b20b7139	2024-02-28	Warnings	Exact identifier application number: M016
XtraCare Foaming Facial Cleanser	TRICLOSAN	Rejoice International	313fcd4a-8641-417e-bf0b-02359ad815fe	2024-02-28	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