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 26 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DERMATITIS FACE BALM	COLLOIDAL OATMEAL	Skinfix, Inc.	86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6	2026-01-08	Warnings	Exact identifier application number: M016
First Aid Beauty Dry Skin Rescue Kit 5x Hydration Power	COLLOIDAL OATMEAL	JCS Global Distribution, Inc.	47d06283-21cd-4a69-e063-6294a90adb05	2026-01-07	Warnings	Exact identifier application number: M016
DE LA CRUZ DIAPER RASH	ALLANTOIN, PETROLATUM, AND ZINC OXIDE	DLC Laboratories, Inc.	5949aa0f-a7cb-453c-81fd-9fa24653a452	2026-01-07	Warnings	Exact identifier application number: M016
Thera Wise Natural Hemorrhoidal	WITCH HAZEL	Derma Wise Skin Care Ltd.	a29fb680-cfc8-4a7b-9970-563fa0e2bed6	2026-01-06	Warnings	Exact identifier application number: M016
Sky and Sol SPF25 Lip Balm	SKY AND SOL SPF25 LIP BALM	Guangzhou Fantesy Biotechnology Co.,Ltd	1f37c0c3-6443-60a3-e063-6394a90a596f	2026-01-05	Warnings	Exact identifier application number: M016
Remedy Essentials	WHITE PETROLATUM,ZINC OXIDE	Medline Industries, LP	42a033d6-782b-2d7f-e054-00144ff8d46c	2026-01-05	Warnings	Exact identifier application number: M016
BUNUSS Estriol Face	ESTRIOL	Jiashen International Trade Limited	478b5690-038a-ba1c-e063-6394a90a3ad6	2026-01-04	Warnings	Exact identifier application number: M016
Skin Protectant for Babies and kids	SKIN PROTECTANT OINTMENT	Neilmed Pharmaceuticals Inc.	448b70db-ca81-db7b-e063-6294a90a5f0d	2026-01-02	Warnings	Exact identifier application number: M016
Puriya Eczema Cream	COLLOIDAL OATMEAL	IPC Republic, Inc.	24ac044e-13fa-5ff6-e063-6294a90a9985	2026-01-01	Warnings	Exact identifier application number: M016
Scarzen	DIMETHICONE	Village Pharma LLC	1550f4e5-22e2-491f-8184-de65da7234e6	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU 100 PURE PETROLEUM	WHITE PETROLATUM	JC SALES	48f74b99-7ead-b0d0-e063-6394a90a4929	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	JC SALES	48f79c2a-b314-169f-e063-6294a90a576e	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	JC SALES	490ac0a6-eac0-a74f-e063-6394a90a84ed	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM COCOA BUTTER	WHITE PETROLATUM	JC SALES	490af001-c78c-e2d2-e063-6394a90abdb0	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU 100 PURE PETROLEUM	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	4946ac1a-f475-fbb1-e063-6394a90a30bc	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	4946d1b7-ae1b-1e73-e063-6394a90a1ed2	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	49471d77-303a-8536-e063-6394a90aea51	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM COCOA BUTTER	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	49472319-09d1-7c4f-e063-6294a90a26a7	2026-01-01	Warnings	Exact identifier application number: M016
Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance Free	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	1fa6282a-172e-f5c8-e063-6294a90a4fb1	2025-12-31	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Latte	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	27713ae6-b428-e0d7-e063-6394a90a7a89	2025-12-31	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