FDA.reportPublic FDA data

BABYGANICS ECZEMA

Product NDC
59062-1303
Requested package NDC
59062-1303-1
11-digit product format
590621303
Labeler code
59062
Product ID
59062-1303_5b42eded-33a3-47a6-9a33-550d6966552f
Type
HUMAN OTC DRUG
Nonproprietary name
OATMEAL
Dosage form
LOTION
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
OATMEAL
Active strength
10 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 packagepackage59062-130359062-1303-1DDiscontinued by firm2026-10-15

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
59062-1303-12020-02-04C16284748780-19d75b9d1-1875-f424-e053-dadaa90a57cebabyganics® Eczema Lotion
59062-1303-12020-01-31C16284748780-19d75b9d1-1875-f424-e053-dadaa90a57cebabyganics® Eczema Lotion

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663YBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
OATMEALACTIVE MOIETY8PI54V663YBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
CARROT SEED OILINACTIVE INGREDIENT595AO13F11BABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNABABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
CHIA SEED OILINACTIVE INGREDIENTMC2LH51BO7BABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
CRANBERRY SEED OILINACTIVE INGREDIENT73KDS3BW5EBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
GLYCERYL DILAURATEINACTIVE INGREDIENTMFL3ZIE8SKBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
NIGELLA SATIVA SEED OILINACTIVE INGREDIENTCS4U38E731BABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
OATINACTIVE INGREDIENTZ6J799EAJKBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
PHYTATE SODIUMINACTIVE INGREDIENT88496G1ERLBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
RASPBERRY SEED OILINACTIVE INGREDIENT9S8867952ABABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
SODIUM HYDROXYMETHYLGLYCINATEINACTIVE INGREDIENTDIG6BWZ9XTBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8BABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
WATERINACTIVE INGREDIENT059QF0KO0RBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-1303BABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]5Legacy NDC20241222_8dc620b9-6d75-46a3-9a8d-d796d5027b0f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59062-1303-15906213030185 g in 1 TUBE (59062-1303-1) 85 g2013-06-210000-00-00NoNoCurrent