Mustela Diaper Rash Sprayable

Product NDC
64768-2928
11-digit product format
647682928
Labeler code
64768
Product ID
64768-2928_284b31ef-6e4d-af01-e063-6394a90ae06e
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
2022-03-07
Substance
ZINC OXIDE
Active strength
149 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 Sprayable
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE149 mg/mL

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
2595464Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9a2aaf6-ab71-97a3-e053-2a95a90a3498Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64768-2928-1Mustela Diaper Rash Sprayable88 mL in 1 BOTTLE, SPRAYCREAM884

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64768-2928MUSTELA DIAPER RASH SPRAYABLE (ZINC OXIDE) CREAM [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]4Current NDC, Legacy NDC, 1 package rows20241204_d9a2aaf6-ab71-97a3-e053-2a95a90a3498.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 65 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
GNP Witch HazelWITCH HAZELAmerisource Bergen45ac839d-215d-4c5f-8ae5-5e111d1700612023-12-14WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin ProtectantGLYCERINL'Oreal USA Products Inc32eaaaab-41bd-4efe-a71d-92e3a702c1e52023-12-11WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema ReliefOATMEALCOSMETIQUE ACTIVE PRODUCTIONe555de17-9b42-4125-a17b-467bc1d179d72023-12-11WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing ReliefOATMEALL'Oreal USA Products Incf7b71606-0044-4729-82e8-4514331806a02023-12-11WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5GLYCERINCosmetique Active Production01c8a0d5-bcd1-4639-be45-530a226401f02023-12-11WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.0bc6812a-5c2a-7bb9-e063-6294a90a36e32023-12-05WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.34fae56e-367d-4659-af2d-1c9ddaf1639c2023-12-05WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDERejoice International Corp.0ba98cdf-489e-dc2a-e063-6294a90adb382023-12-04WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDEChina Ningbo Shangge Cosmetics Technology Corp.0baa8a14-8655-d77c-e063-6294a90ab8aa2023-12-04WarningsExact identifier
application number: M016
THERAPLEX Eczema TherapyOATMEALTHERAPLEX, LLC86472a3d-7138-4141-8422-ab20c17a46e02023-12-04WarningsExact identifier
application number: M016
SOOTHE Moisturizing Rescue CreamOATMEALRodan & Fields91163267-c2aa-47b3-b290-d1605536d8062023-12-04WarningsExact identifier
application number: M016
Manzatin-E Diaper Rash Skin ProtectantZINC OXIDELaboratorios Zepol S.A.cafd084f-8493-4d6e-b256-2d4b4282f8662023-12-01WarningsExact identifier
application number: M016
Manzatin Diaper Rash Skin ProtectantZINC OXIDELaboratorios Zepol S.A.5c1618a4-ca08-4814-a556-74e79db618b92023-12-01WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2595464zinc oxide 14.9 % Topical SprayPSNd9a2aaf6-ab71-97a3-e053-2a95a90a34984
2595464zinc oxide 149 MG/ML Topical SpraySCDd9a2aaf6-ab71-97a3-e053-2a95a90a34984
2595464zinc oxide 14.9 % Topical SpraySYd9a2aaf6-ab71-97a3-e053-2a95a90a34984
2595464ZNO 149 MG/ML Topical SpraySYd9a2aaf6-ab71-97a3-e053-2a95a90a34984

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64768-2928-16476829280188 mL in 1 BOTTLE, SPRAY (64768-2928-1) 88 ml2022-03-070000-00-00NoNoCurrent