Diaper Rash

Product NDC: 36800-020
11-digit product format: 368000020
Labeler code: 36800
Product ID: 36800-020_4ab76881-f9d4-be0e-e063-6394a90a9c5b
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc oxide
Dosage form: PASTE
Route: TOPICAL
Labeler: Topco Associates LLC
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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8acb1b47-70ed-4aa2-a7c0-e807042affc7	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-020-26	Diaper Rash	1 in 1 CARTON	PASTE	1		17
36800-020-26	Diaper Rash	113 g in 1 TUBE	PASTE	113		17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	DIAPER RASH (ZINC OXIDE) PASTE [TOPCARE ASSOCIATES, LLC]	2
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	DIAPER RASH (ZINC OXIDE) PASTE [TOPCARE ASSOCIATES, LLC]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	DIAPER RASH (ZINC OXIDE) PASTE [TOPCARE ASSOCIATES, LLC]	2
COD LIVER OIL	INACTIVE INGREDIENT	BBL281NWFG	DIAPER RASH (ZINC OXIDE) PASTE [TOPCARE ASSOCIATES, LLC]	2
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	DIAPER RASH (ZINC OXIDE) PASTE [TOPCARE ASSOCIATES, LLC]	2
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	DIAPER RASH (ZINC OXIDE) PASTE [TOPCARE ASSOCIATES, LLC]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	DIAPER RASH (ZINC OXIDE) PASTE [TOPCARE ASSOCIATES, LLC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIAPER RASH (ZINC OXIDE) PASTE [TOPCARE ASSOCIATES, LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIAPER RASH (ZINC OXIDE) PASTE [TOPCARE ASSOCIATES, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-020	DIAPER RASH (ZINC OXIDE) PASTE [TOPCO ASSOCIATES LLC]	16	Current NDC, Legacy NDC, 2 package rows	20250406_8acb1b47-70ed-4aa2-a7c0-e807042affc7.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 19 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calamine	FERRIC OXIDE RED	Perrigo Direct, Inc	256bd1d4-fd50-408f-9aee-84f218bb4971	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Perrigo Direct, Inc	e11470b2-80d6-4008-b87e-eb6aeadfce74	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Perrigo Direct, Inc	cc0378f2-6d5f-47ec-b16a-64668b4c29cc	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXIND HCL	Perrigo Direct, Inc	54a20ec9-ab86-4410-af94-e04393e9d4b3	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Meijer, Inc.	adc3bb9b-ed8a-4b65-b44c-1d1e978c89ec	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Meijer, Inc.	1b72f927-c2ae-4190-a035-5d7bb9f53c15	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Meijer, Inc.	af293cc0-ccd5-42a6-861b-c19fa6ffd06a	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Healing for Babies	PETROLATUM	Meijer, Inc.	09878fe0-0890-4af3-a3f6-d2890041e9f8	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Meijer, Inc.	fa8ae34c-7b68-454f-8a3b-0eaa93a34092	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Diaper Rash	ZINC OXIDE	Meijer, Inc.	04bec667-a11e-42d2-a4b3-1416eebf1e8d	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Healing	PETROLATUM	Meijer, Inc.	8cb56ee4-b9d1-4a29-88c7-e6f3ac2112c1	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Meijer, Inc.	6b369ef2-fd54-4931-a9eb-0fb42834c2ef	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Dimethicone	DIMETHICONE	Meijer, Inc.	75b91b97-ea84-4c4d-9e58-5a9ff27a778c	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	Meijer, Inc.	d36a7479-7b3b-49fe-8144-b5cce0e173fb	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DAILY MOISTURIZING	Meijer, Inc.	44949b46-70f2-4e52-adba-a8455da614eb	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Meijer, Inc.	13e4aece-5b91-4f89-a912-540bf170a8d1	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Target Corporation	7fb5f9ca-cd90-4933-9fe8-907ece00458b	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Target Corporation	d4ee05c8-ae62-45df-8783-1ed57fa030ec	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Target Corporation	5237c7f2-7135-4558-a758-4fc2a232172f	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Target Corporation	3e620e4f-9e29-9e39-e063-6394a90adeda	2026-02-18	Warnings, Adverse reactions	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-020-26	36800002026	1 TUBE in 1 CARTON (36800-020-26) / 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
Tippy Toes 020.002/020AC-AD Diaper Rash Ointment 40% Zinc Oxide	Topco Associates LLC \| Nice-Pak Products, LLC	2026-02-13	HUMAN OTC DRUG LABEL	17