FDA.reportPublic FDA data

BABYGANICS DIAPER RASH

Product NDC
59062-1219
Requested package NDC
59062-1219-1
11-digit product format
590621219
Labeler code
59062
Product ID
59062-1219_3dc9c9ae-0376-48b4-8002-e5298ab41a2f
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
KAS Direct LLC dba BabyGanics
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-06-21
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
150 mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59062-121959062-1219-1DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59062-1219-12020-02-04C16284748780-19d75b9d0-eca4-f424-e053-dadaa90a57cebabyganics ® diaper rash cream
59062-1219-12020-01-31C16284748780-19d75b9d0-eca4-f424-e053-dadaa90a57cebabyganics ® diaper rash cream

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
ALUMINUM STEARATEINACTIVE INGREDIENTU6XF9NP8HMBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RABABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
CETYL RICINOLEATEINACTIVE INGREDIENT1P677500YDBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
CRANBERRY SEED OILINACTIVE INGREDIENT73KDS3BW5EBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POTBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
GLYCERYL CAPRATEINACTIVE INGREDIENT197M6VFC1WBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0EBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
HYDROGENATED POLYDECENE (550 MW)INACTIVE INGREDIENTU333RI6EB7BABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EPBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
JOJOBA OILINACTIVE INGREDIENT724GKU717MBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
NIGELLA SATIVA SEED OILINACTIVE INGREDIENTCS4U38E731BABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
POLYGLYCERYL-3 RICINOLEATEINACTIVE INGREDIENTMZQ63P0N0WBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
RASPBERRY SEED OILINACTIVE INGREDIENT9S8867952ABABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
SHEANUT OILINACTIVE INGREDIENTO88E196QRFBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
SODIUM TAURATEINACTIVE INGREDIENTY7LJA74T0NBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ABABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
TOMATO SEED OILINACTIVE INGREDIENT7N87T9C06TBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
TRIDECETH-10INACTIVE INGREDIENTG624N6MSBABABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
WATERINACTIVE INGREDIENT059QF0KO0RBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VBABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-1219BABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]5Legacy NDC20241222_253c4065-bb58-413f-8ee4-dbd1576f33ae.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59062-1219-1590621219011 TUBE in 1 CARTON (59062-1219-1) > 113 g in 1 TUBE1 tube2013-06-210000-00-00NoNoCurrent