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 63 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quality Choice Anti-Itch Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Chain Drug Market Association	e3c0c46d-3d85-411d-a543-009064cdd19e	2023-12-28	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Therapeutic Hand	DIMETHICONE	L'Oreal USA Products Inc	7fe49112-4180-415c-a380-768a8d6b2185	2023-12-28	Warnings	Exact identifier application number: M016
Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Pharma Nobis, LLC	e42fccc2-1b4e-e7f3-e053-2a95a90aef39	2023-12-26	Warnings	Exact identifier application number: M016
Calamine Phenolated Topical Suspension	CALAMINE AND ZINC OXIDE AND PHENOL	Pharma Nobis, LLC	e42fbdcc-3291-7761-e053-2995a90a7172	2023-12-26	Warnings	Exact identifier application number: M016
Humco Calagesic	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Pharma Nobis, LLC	e42fb807-8cb4-ed25-e053-2995a90a6780	2023-12-26	Warnings	Exact identifier application number: M016
Leader Calamine Plus	ZINC OXIDE LOTION	Cardinal Health, 110 dba Leader	81f29789-f794-1e64-e053-2a91aa0ac85e	2023-12-22	Warnings	Exact identifier application number: M016
CVS Calamine Plus	ZINC OXIDE	CVS Pharmacy	b90cd214-d44a-4458-876d-59cc0795226d	2023-12-22	Warnings	Exact identifier application number: M016
Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Pharma Nobis, LLC	e42f0bd6-3ad3-7e07-e053-2995a90a564a	2023-12-22	Warnings	Exact identifier application number: M016
DDM Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Discount Drug Mart	5d53685b-ca4c-35c1-e053-2a91aa0aff6e	2023-12-20	Warnings	Exact identifier application number: M016
DDM Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Discount Drug Mart	5d537a11-049e-0a8d-e053-2a91aa0aa0c3	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Strategic Sourcing Services LLC	349ea07d-79bc-46f3-9d60-85b40db51bbb	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	2a1d9b27-0bd4-4475-8218-ba0f5560a969	2023-12-20	Warnings	Exact identifier application number: M016
Quality Choice Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Chain Drug Market Association	62fe653f-e861-472b-b193-4fdd9d25de8d	2023-12-20	Warnings	Exact identifier application number: M016
Premier Value Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Chain Drug Consortium	5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b	2023-12-20	Warnings	Exact identifier application number: M016
Best Choice Medicated Calamine	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Valu Merchandisers, CO.	5d6c668a-80b4-de18-e053-2991aa0a38fb	2023-12-20	Warnings	Exact identifier application number: M016
Premiere Value Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Chain Drug Consortium	5c8bde5a-591d-085f-e053-2991aa0a56af	2023-12-20	Warnings	Exact identifier application number: M016
Best Choice Anti-Itch Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Valu Merchandisers, CO	5d6c51b8-47f8-c38b-e053-2991aa0a0f23	2023-12-20	Warnings	Exact identifier application number: M016
Health Care Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Great Lakes Wholesale, Marketing and Sales Inc	5d8f02fb-0794-8ec2-e053-2991aa0aac63	2023-12-20	Warnings	Exact identifier application number: M016
Harris Teetter Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Harris Tetter, LLC.	5c7a7418-c973-2869-e053-2991aa0ab4f5	2023-12-20	Warnings	Exact identifier application number: M016
Harris Teeter Calamine	ZINC OXIDE	Harris Teeter, LLC.	86021cc5-fea7-4363-8fb2-2b0484437fe8	2023-12-20	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