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 60 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Honest Eczema Balm	COLLOIDAL OATMEAL	The Honest Company, Inc.	35b8bc5c-420e-4d31-9659-f36cabbd897a	2024-05-14	Warnings	Exact identifier application number: M016
Extra Strength Itch Stopping	ITCH STOPPING CREAM	Universal Distribution Centre LLC	b9a42aa3-1903-76f0-e053-2a95a90a51d1	2024-05-13	Warnings	Exact identifier application number: M016
Calamine Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	Cardinal Health, 110 dba Leader	7f733c0a-82b2-d3b0-e053-2991aa0a6b0f	2024-05-13	Warnings	Exact identifier application number: M016
Walgreens Maximum Diaper Rash	ZINC OXIDE	Walgreens Company	5eb2152f-6fa2-4191-878a-207416e69818	2024-05-07	Warnings	Exact identifier application number: M016
Cetaphil Eczema Rapid Relief Cream	COLLOIDAL OATMEAL	Galderma Laboratories, L.P.	02a405fa-8ae9-41e9-b86f-ef5fb6e3844a	2024-05-02	Warnings	Exact identifier application number: M016
Chapstick	AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM	Haleon US Holdings LLC	0e34fc74-772e-48fd-a353-58807ef412c1	2024-05-01	Warnings	Exact identifier application number: M016
Diaper Rash Cream 40% ZINC	ZINC OXIDE	ASTONEA LABS PRIVATE LIMITED	16da985a-6210-ec82-e063-6294a90a132d	2024-04-24	Warnings	Exact identifier application number: M016
Petrolatum Jelly	PETROLATUM	ASTONEA LABS PRIVATE LIMITED	16dac8e5-aeb8-592d-e063-6394a90ae2b6	2024-04-24	Warnings	Exact identifier application number: M016
Monistat Complete Care Chafing Relief	DIMETHICONE	Insight Pharmaceuticals LLC	07d7c883-1fa3-4786-905c-a1fab649765e	2024-04-19	Warnings	Exact identifier application number: M016
zinc oxide 20%	ZINC OXIDE 20%	Bionpharma Inc	1549500a-0941-0fba-e063-6394a90a564e	2024-04-18	Warnings	Exact identifier application number: M016
ARC Skin Protectant	ALLANTOIN	Anjon Biologics, Inc	f4ff79dd-cb38-4cca-9631-a2758a171873	2024-04-18	Warnings	Exact identifier application number: M016
Zinctral	ZINC OXIDE	PureTek Corporation	de990834-00da-0c7a-e053-2995a90a7c37	2024-04-15	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Variety Pack	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Haleon US Holdings LLC	bfb9a2d5-1ad2-45b8-a215-9d1370af5337	2024-04-12	Warnings	Exact identifier application number: M016
ChapStick Classic Spearmint	PETROLATUM	Haleon US Holdings LLC	d39786e8-bcd8-479d-8990-142a21788a47	2024-04-12	Warnings	Exact identifier application number: M016
Chapstick 12 Days of Christmas	WHITE PETROLATUM	Haleon US Holdings LLC	d6eb2ea6-27c7-40a6-a1f0-789ea2131de3	2024-04-11	Warnings	Exact identifier application number: M016
Chapstick Active 2in1 Variety Pack	ZINC OXIDE	Haleon US Holdings LLC	d1998a9e-d61f-4b4c-91b0-5e66754bcc4a	2024-04-11	Warnings	Exact identifier application number: M016
Chapstick 12 Days of Christmas	WHITE PETROLATUM	Haleon US Holdings LLC	040694f0-b5ba-4203-bde9-699fa9b1afef	2024-04-11	Warnings	Exact identifier application number: M016
Chapstick Holiday Classics Kit	WHITE PETROLATUM	Haleon US Holdings LLC	6df216dc-c03d-463a-8029-5e54c1dc3d27	2024-04-11	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated SPF15 Triple Force Formula	OCTINOXATE, OXYBENZONE, WHITE PETROLATUM	Carma Laboratories, Inc.	3eb0f8ff-89e7-4410-8573-3349e4946548	2024-04-02	Warnings	Exact identifier application number: M016
Pure Cornstarch Baby	CORN STARCH	Walgreen Company	d0e9bd13-b568-4f7e-b036-8d23e71ad8bf	2024-03-25	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