FDA.reportPublic FDA data

MUSTELA Diaper Rash 1 2 3

Product NDC
64768-2922
11-digit product format
647682922
Labeler code
64768
Product ID
64768-2922_284b3019-91c5-b146-e063-6394a90acac0
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
Substance
ZINC OXIDE
Active strength
9.9 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MUSTELA Diaper Rash 1 2 3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE9.9 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z
Rxcui2106103

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64768-2922-1MUSTELA Diaper Rash 1 2 3107.8 g in 1 TUBECREAM107.87
64768-2922-1MUSTELA Diaper Rash 1 2 31 in 1 CARTONCREAM17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
4,4-DIMETHYLOXAZOLIDINEINACTIVE INGREDIENT96J42P99ZAMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
AVOCADOINACTIVE INGREDIENTSDS87L369FMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC1MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
CAPRYLOYL GLYCINEINACTIVE INGREDIENT8TY5YO42NJMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
COCO-CAPRYLATE/CAPRATEINACTIVE INGREDIENT8D9H4QU99HMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
ETHYL LINOLENATEINACTIVE INGREDIENTT54Y8H042VMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
LEVULINIC ACIDINACTIVE INGREDIENTRYX5QG61EIMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATEINACTIVE INGREDIENT9229XJ4V12MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
POLYGLYCERYL-3 DIISOSTEARATEINACTIVE INGREDIENT46P231IQV8MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51EMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
SODIUM LEVULINATEINACTIVE INGREDIENTVK44E1MQU8MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
STEARALKONIUM HECTORITEINACTIVE INGREDIENTOLX698AH5PMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
WATERINACTIVE INGREDIENT059QF0KO0RMUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VMUSTELA 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
NDCDashboard titleSPL versionValidationDashboard ZIP
64768-2922MUSTELA DIAPER RASH 1 2 3 (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]7Current NDC, Legacy NDC, 2 package rows20241204_163f388e-849d-4b7e-93c1-9045d77a9ec2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2106103zinc oxide 9.9 % Topical CreamPSN163f388e-849d-4b7e-93c1-9045d77a9ec27
2106103zinc oxide 99 MG/ML Topical CreamSCD163f388e-849d-4b7e-93c1-9045d77a9ec27
2106103zinc oxide 9.9 % Topical CreamSY163f388e-849d-4b7e-93c1-9045d77a9ec27
2106103ZNO 99 MG/ML Topical CreamSY163f388e-849d-4b7e-93c1-9045d77a9ec27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64768-2922-1647682922011 TUBE in 1 CARTON (64768-2922-1) / 107.8 g in 1 TUBE1 tube2017-01-090000-00-00NoNoCurrent