MUSTELA Diaper Rash 1 2 3

Product NDC: 64768-2922
11-digit product format: 647682922
Labeler code: 64768
Product ID: 64768-2922_5995d8e5-7e8b-eec5-e063-6394a90ab31b
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Expanscience Laboratories d/b/a Mustela
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-01-09
Marketing end: 2029-08-31
Substance: ZINC OXIDE
Active strength: 9.9 g/100g
NDC exclude flag: No
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: MUSTELA Diaper Rash 1 2 3

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	9.9 g/100g

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
2106103	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
163f388e-849d-4b7e-93c1-9045d77a9ec2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64768-2922-1	MUSTELA Diaper Rash 1 2 3	107.8 g in 1 TUBE	CREAM	107.8		7
64768-2922-1	MUSTELA Diaper Rash 1 2 3	1 in 1 CARTON	CREAM	1		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
4,4-DIMETHYLOXAZOLIDINE	INACTIVE INGREDIENT	96J42P99ZA	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
AVOCADO	INACTIVE INGREDIENT	SDS87L369F	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
AVOCADO OIL	INACTIVE INGREDIENT	6VNO72PFC1	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
CAPRYLOYL GLYCINE	INACTIVE INGREDIENT	8TY5YO42NJ	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
COCO-CAPRYLATE/CAPRATE	INACTIVE INGREDIENT	8D9H4QU99H	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
ETHYL LINOLENATE	INACTIVE INGREDIENT	T54Y8H042V	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
LEVULINIC ACID	INACTIVE INGREDIENT	RYX5QG61EI	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
MAGNESIUM SULFATE	INACTIVE INGREDIENT	DE08037SAB	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE	INACTIVE INGREDIENT	9229XJ4V12	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
POLYGLYCERYL-3 DIISOSTEARATE	INACTIVE INGREDIENT	46P231IQV8	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
PROPYLENE CARBONATE	INACTIVE INGREDIENT	8D08K3S51E	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
SODIUM LEVULINATE	INACTIVE INGREDIENT	VK44E1MQU8	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
STEARALKONIUM HECTORITE	INACTIVE INGREDIENT	OLX698AH5P	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64768-2922	MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]	7	Current NDC, Legacy NDC, 2 package rows	20241204_163f388e-849d-4b7e-93c1-9045d77a9ec2.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 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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

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
2106103	zinc oxide 9.9 % Topical Cream	PSN	163f388e-849d-4b7e-93c1-9045d77a9ec2	7
2106103	zinc oxide 99 MG/ML Topical Cream	SCD	163f388e-849d-4b7e-93c1-9045d77a9ec2	7
2106103	zinc oxide 9.9 % Topical Cream	SY	163f388e-849d-4b7e-93c1-9045d77a9ec2	7
2106103	ZNO 99 MG/ML Topical Cream	SY	163f388e-849d-4b7e-93c1-9045d77a9ec2	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64768-2922-1	64768292201	1 TUBE in 1 CARTON (64768-2922-1) / 107.8 g in 1 TUBE	1 tube	2017-01-09	2029-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MUSTELA® Diaper Rash Cream 1 2 3	Expanscience Laboratories d/b/a Mustela	2026-08-21	HUMAN OTC DRUG LABEL	9