Home NDC 79265-8655 Babo Botanicals Sensitive Baby Healing
Product NDC 79265-8655
11-digit product format 792658655
Labeler code 79265
Product ID 79265-8655_0865929f-e8c6-3f68-e063-6294a90ac71c
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal
Dosage form OINTMENT
Route TOPICAL
Labeler Babo Botanicals, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-23
Substance OATMEAL
Active strength 10 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 2027-12-31
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 Babo Botanicals Sensitive Baby Healing
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 10 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 1545142 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79265-8655-1 Babo Botanicals Sensitive Baby Healing 113 g in 1 JAR OINTMENT 113 1 79265-8655-1 Babo Botanicals Sensitive Baby Healing 1 in 1 BOX OINTMENT 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79265-8655 BABO BOTANICALS SENSITIVE BABY HEALING (COLLOIDAL OATMEAL) OINTMENT [BABO BOTANICALS, INC.] 1 Current NDC, 2 package rows 20231024_08659a5c-2d10-2f98-e063-6394a90a7760.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 39 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 79265-8655-1 79265865501 1 JAR in 1 BOX (79265-8655-1) / 113 g in 1 JAR 1 jar 2023-10-23 No No Current