Home NDC 59062-3301 Babyganics Soothing Itch
Product NDC 59062-3301
11-digit product format 590623301
Labeler code 59062
Product ID 59062-3301_276ffcf7-af12-4eec-87c7-e4a4aa7152b4
Type HUMAN OTC DRUG
Nonproprietary name OATMEAL
Dosage form STICK
Route TOPICAL
Labeler KAS Direct, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-01
Substance OATMEAL
Active strength 100 mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
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 Babyganics Soothing Itch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 100 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8PI54V663Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1745093 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59062-3301-1 Babyganics Soothing Itch 1 in 1 CARTON STICK 1 1 59062-3301-1 Babyganics Soothing Itch 18 g in 1 APPLICATOR STICK 18 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59062-3301 BABYGANICS SOOTHING ITCH (OATMEAL) STICK [KAS DIRECT, LLC] 1 Current NDC, 2 package rows 20240901_5c2806fb-5af4-4532-b31a-be77bb23b277.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 52 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59062-3301-1 59062330101 1 APPLICATOR in 1 CARTON (59062-3301-1) / 18 g in 1 APPLICATOR 1 applicator 2024-09-01 No No Current