Diaper Rash

Product NDC: 55910-020
11-digit product format: 559100020
Labeler code: 55910
Product ID: 55910-020_4c0e9851-5eb4-8e58-e063-6294a90aa4cc
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc oxide
Dosage form: PASTE
Route: TOPICAL
Labeler: Old East Main Co.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-05-10
Substance: ZINC OXIDE
Active strength: 400 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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: 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
1094560	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
7f56ab98-dbd8-412a-8c31-bb6302b7f329	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55910-020-26	Diaper Rash	1 in 1 CARTON	PASTE	1		19
55910-020-26	Diaper Rash	113 g in 1 TUBE	PASTE	113		19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	DIAPER RASH (ZINC OXIDE) PASTE [DOLGENCORP, LLC]	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	DIAPER RASH (ZINC OXIDE) PASTE [DOLGENCORP, LLC]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	DIAPER RASH (ZINC OXIDE) PASTE [DOLGENCORP, LLC]	1
COD LIVER OIL	INACTIVE INGREDIENT	BBL281NWFG	DIAPER RASH (ZINC OXIDE) PASTE [DOLGENCORP, LLC]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	DIAPER RASH (ZINC OXIDE) PASTE [DOLGENCORP, LLC]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	DIAPER RASH (ZINC OXIDE) PASTE [DOLGENCORP, LLC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	DIAPER RASH (ZINC OXIDE) PASTE [DOLGENCORP, LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIAPER RASH (ZINC OXIDE) PASTE [DOLGENCORP, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIAPER RASH (ZINC OXIDE) PASTE [DOLGENCORP, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-020	DIAPER RASH (ZINC OXIDE) PASTE [OLD EAST MAIN CO.]	18	Current NDC, Legacy NDC, 2 package rows	20250331_7f56ab98-dbd8-412a-8c31-bb6302b7f329.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 66 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petrolatum Jelly	PETROLATUM	NEW PRIDE CORP	f6634410-fa1f-7987-e053-2995a90abb06	2023-12-01	Warnings	Exact identifier application number: M016
Cetaphil Cracked Skin Repair Balm	DIMETHICONE	Galderma Laboratories, L.P.	5efb3ef0-6ee9-4ef8-b81e-90bd1825c956	2023-11-30	Warnings	Exact identifier application number: M016
Cetaphil Cracked Skin Repair	DIMETHICONE	Galderma Laboratories, L.P.	27d74e0f-8359-4c59-bf7f-acade7f4545c	2023-11-30	Warnings	Exact identifier application number: M016
Sheffield Advanced Scar Gel	ADVANCED SCAR GEL	Sheffield Pharmaceuticals LLC	ab78b946-81ed-442c-a167-26c26c7fe8a1	2023-11-30	Warnings	Exact identifier application number: M016
Akin Diaper Rash	ZINC OXIDE	Southern Sales & Service, Inc.	f5515517-7977-48f9-aab6-cf0d2f2a04a0	2023-11-29	Warnings	Exact identifier application number: M016
Dr. Sheffield Diaper Rash	ZINC OXIDE	Sheffield Pharmaceuticals LLC	cac77320-b5cf-4edf-9693-ebabfb61390c	2023-11-28	Warnings	Exact identifier application number: M016
Sheffield Zinc Oxide	ZINC OXIDE	Sheffield Pharmaceuticals LLC	60b54c04-4387-4954-951d-165809947310	2023-11-28	Warnings	Exact identifier application number: M016
Cetaphil Baby Soothe and Protect Cream	ALLANTOIN	Galderma Laboratories, L.P.	38254e03-3716-4e45-86b7-06430ebadc86	2023-11-22	Warnings	Exact identifier application number: M016
Cetaphil Baby Eczema Soothing	COLLOIDAL OATMEAL	Galderma Laboratories, L.P.	d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b	2023-11-22	Warnings	Exact identifier application number: M016
EczemaHoneyBodyLotion	COLLOIDAL OATMEAL	Allure Labs	0a710be0-562e-8368-e063-6294a90a3b1b	2023-11-18	Warnings	Exact identifier application number: M016
Zinc Oxide	SKIN PROTECTANT	BluePoint Laboratories	d9b752e6-655a-19a6-e053-2995a90a9a37	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL ORIGINAL PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	47b8c720-ad1e-4ac7-ba73-872e409b38bf	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	1ac9ee69-339d-4426-b3bf-13e5386f1a9b	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	cf888bf3-6950-43aa-b4be-5a32961b4d96	2023-11-15	Warnings	Exact identifier application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	b6e0ddb8-3761-482a-83d0-15d612d142eb	2023-11-15	Warnings	Exact identifier application number: M016
DERMA SANTE Anti Eczema Cream	OATMEAL	Hope Science Inc.	1492a6ad-016c-4307-8286-5c564de9e160	2023-11-11	Warnings	Exact identifier application number: M016
M3 NATURALS Eczema Cream	OATMEAL	M3 Naturals LLC	45e2cdde-58fb-4eea-a54d-f53f9ad0d854	2023-11-11	Warnings	Exact identifier application number: M016
THERAPLEX Eczema Therapy	OATMEAL	THERAPLEX, LLC	53900588-5c9e-4164-816d-017bdbb0f31b	2023-11-11	Warnings	Exact identifier application number: M016
Boudreauxs Butt Diaper Rash Max Strength	ZINC OXIDE	Geodis Logistics LLC	1b4fd6cb-f2dc-40a2-b958-e99caec91793	2023-11-10	Warnings	Exact identifier application number: M016
Boudreauxs Butt Diaper Rash Original	ZINC OXIDE	Geodis Logistics LLC	97587458-4ca0-4de3-9bb9-148346d859c0	2023-11-10	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
1094560	zinc oxide 40 % Topical Paste	PSN	7f56ab98-dbd8-412a-8c31-bb6302b7f329	19
1094560	zinc oxide 0.4 MG/MG Paste	SCD	7f56ab98-dbd8-412a-8c31-bb6302b7f329	19
1094560	zinc oxide 40 % Paste	SY	7f56ab98-dbd8-412a-8c31-bb6302b7f329	19
1094560	ZNO 0.4 MG/MG Paste	SY	7f56ab98-dbd8-412a-8c31-bb6302b7f329	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-020-26	55910002026	1 TUBE in 1 CARTON (55910-020-26) / 113 g in 1 TUBE	1 tube	2012-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gentle Steps 020.002/020AC-AD Diaper Rash Ointment 40% Zinc Oxide	Old East Main Co. \| Nice-Pak Products, LLC	2026-03-02	HUMAN OTC DRUG LABEL	19