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 58 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BioBarrier Renewal Cream	ALLANTOIN	bluemercury	1ee15f84-0561-3cd2-e063-6394a90ab68e	2024-09-15	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Strategic Sourcing Services, LLC	22173332-9d09-768c-e063-6394a90a94e1	2024-09-14	Warnings	Exact identifier application number: M016
Diaper Rash Cream 5.6oz	ZINC OXIDE	China Ningbo Shangge Cosmetics Technology Corp.	21a7c4ce-1360-931c-e063-6294a90aa66d	2024-09-11	Warnings	Exact identifier application number: M016
Healing Cream 3oz	PETROLATUM	China Ningbo Shangge Cosmetics Technology Corp.	21bdbb13-cc64-b5d7-e063-6294a90ae3fd	2024-09-11	Warnings	Exact identifier application number: M016
Healing Cream15oz	PETROLATUM	Rejoice International Corp.	21e4026c-d3da-e4f7-e063-6394a90aabed	2024-09-11	Warnings	Exact identifier application number: M016
Baby Balm Stick 0.65oz	PETROLATUM OINTMENT	China Ningbo Shangge Cosmetics Technology Corp.	21c0b614-ea19-e98d-e063-6294a90ac44e	2024-09-10	Warnings	Exact identifier application number: M016
Aveeno Skin Relief Moisturizing Fragrance Free	DIMETHICONE	Kenvue Brands LLC	65476a2a-8cd4-4477-ac27-9a06f41e4711	2024-09-09	Warnings	Exact identifier application number: M016
Diaper Rash Cream 15oz	ZINC OXIDE	Rejoice International Corp.	213213ab-f935-a62e-e063-6394a90af96b	2024-09-03	Warnings	Exact identifier application number: M016
Diaper Rash Cream 5.6oz	ZINC OXIDE	Rejoice International Corp.	2133876b-eaf0-f988-e063-6394a90aae4d	2024-09-03	Warnings	Exact identifier application number: M016
Baby Balm Stick 0.65oz	PETROLATUM	Rejoice International Corp.	20cf3bb8-4ab8-2980-e063-6294a90ad631	2024-08-29	Warnings	Exact identifier application number: M016
SUDOCREM SKIN PROTECTANT	ZINC OXIDE	LEDA INNOVATIONS USA, INC.	20d2cf0b-d237-fd78-e063-6394a90a8d03	2024-08-29	Warnings	Exact identifier application number: M016
Healing Cream 3oz	PETROLATUM	Rejoice International Corp.	20c9b964-c9af-d63a-e063-6294a90ab979	2024-08-28	Warnings	Exact identifier application number: M016
Babyganics Soothing Itch	OATMEAL	KAS Direct, LLC	5c2806fb-5af4-4532-b31a-be77bb23b277	2024-08-28	Warnings	Exact identifier application number: M016
Meijer Baby Petroleum Jelly Skin Protectant Frag Free	PETROLATUM	Meijer Distribution	0a0e6de8-b7c1-af7e-e063-6394a90a3ee2	2024-08-26	Warnings	Exact identifier application number: M016
Meijer Baby Petroleum Jelly Skin Protectant Fresh Scent	PETROLATUM	Meijer Distribution	0a0e9b39-9ce1-e788-e063-6294a90abf0b	2024-08-26	Warnings	Exact identifier application number: M016
Insect sting relief latex 01	SODIUM BICARBONATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	1b9e2d4c-bc0c-6ed0-e063-6294a90a9103	2024-08-19	Warnings	Exact identifier application number: M016
Dove	CARE AND PROTECT ANTIBACTERIAL HAND WASH	Conopco Inc. d/b/a/ Unilever	b9f65122-4037-de0b-e053-2995a90ae510	2024-08-16	Warnings	Exact identifier application number: M016
BioBarrier Repair Eye Cream	ALLANTOIN	Bluemercury Inc.	1ee70a3c-76cc-335f-e063-6294a90a4f49	2024-08-04	Warnings	Exact identifier application number: M016
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHED	ZINC OXIDE	Dabur India Ltd	1e6143c1-cd08-c171-e063-6394a90a2cee	2024-07-29	Warnings	Exact identifier application number: M016
HealthWise Petroleum Jelly	WHITE PETROLATUM	Veridian Healthcare	1e189d97-2677-e8d7-e063-6394a90ac3d6	2024-07-25	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