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 65 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
GNP Witch Hazel	WITCH HAZEL	Amerisource Bergen	45ac839d-215d-4c5f-8ae5-5e111d170061	2023-12-14	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant	GLYCERIN	L'Oreal USA Products Inc	32eaaaab-41bd-4efe-a71d-92e3a702c1e5	2023-12-11	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief	OATMEAL	COSMETIQUE ACTIVE PRODUCTION	e555de17-9b42-4125-a17b-467bc1d179d7	2023-12-11	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief	OATMEAL	L'Oreal USA Products Inc	f7b71606-0044-4729-82e8-4514331806a0	2023-12-11	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5	GLYCERIN	Cosmetique Active Production	01c8a0d5-bcd1-4639-be45-530a226401f0	2023-12-11	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	0bc6812a-5c2a-7bb9-e063-6294a90a36e3	2023-12-05	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	34fae56e-367d-4659-af2d-1c9ddaf1639c	2023-12-05	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2.5oz	ZINC OXIDE	Rejoice International Corp.	0ba98cdf-489e-dc2a-e063-6294a90adb38	2023-12-04	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2.5oz	ZINC OXIDE	China Ningbo Shangge Cosmetics Technology Corp.	0baa8a14-8655-d77c-e063-6294a90ab8aa	2023-12-04	Warnings	Exact identifier application number: M016
THERAPLEX Eczema Therapy	OATMEAL	THERAPLEX, LLC	86472a3d-7138-4141-8422-ab20c17a46e0	2023-12-04	Warnings	Exact identifier application number: M016
SOOTHE Moisturizing Rescue Cream	OATMEAL	Rodan & Fields	91163267-c2aa-47b3-b290-d1605536d806	2023-12-04	Warnings	Exact identifier application number: M016
Manzatin-E Diaper Rash Skin Protectant	ZINC OXIDE	Laboratorios Zepol S.A.	cafd084f-8493-4d6e-b256-2d4b4282f866	2023-12-01	Warnings	Exact identifier application number: M016
Manzatin Diaper Rash Skin Protectant	ZINC OXIDE	Laboratorios Zepol S.A.	5c1618a4-ca08-4814-a556-74e79db618b9	2023-12-01	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