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_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
IngredientStrength
ZINC OXIDE9.9 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2106103Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
163f388e-849d-4b7e-93c1-9045d77a9ec2Available on FDA.report

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

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 64 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact identifier
application number: M016
HEB CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d579680-6bcb-1161-e053-2991aa0aead12023-12-18WarningsExact identifier
application number: M016
Publix Clear Anti-ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6b905f-ed30-1ab7-e053-2a91aa0a816b2023-12-18WarningsExact identifier
application number: M016
Humco CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEHumco Holding Group, Inc.5fca3a73-6d66-496b-bd33-6e044f9039bc2023-12-15WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLHumco Holding Group, Inca3816729-be2b-4b4f-a609-953576cd2e3b2023-12-15WarningsExact identifier
application number: M016
Humco Mineral Oil LightMINERAL OILHumco Holding Group, Inc.753f35c3-1420-4817-ba63-b737a9c99a1d2023-12-15WarningsExact identifier
application number: M016
Humco Witch HazelWITCH HAZELHumco Holding Group, Inc.3cf07016-a129-49ca-8fad-b67dda5aa0092023-12-15WarningsExact identifier
application number: M016
Rite Aid CalamineCALAMINE 8% AND ZINC OXIDE 8%Rite Aid Corporation5df71189-9b36-9dee-e053-2a91aa0a9e492023-12-15WarningsExact identifier
application number: M016

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 tube2017-01-092029-08-31NoNoCurrent