Home NDC 79265-8580 Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash
Product NDC 79265-8580
11-digit product format 792658580
Labeler code 79265
Product ID 79265-8580_186a9642-cd74-adfb-e063-6394a90a75c7
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Babo Botanicals, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-01
Substance ZINC OXIDE
Active strength 250 mg/g
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 Fragrance Free Diaper Rash
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 250 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1125471 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 79265-8580-1 Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash 170 g in 1 JAR CREAM 170 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79265-8580 BABO BOTANICALS SENSITIVE BABY FRAGRANCE FREE DIAPER RASH (ZINC OXIDE) CREAM [BABO BOTANICALS, INC.] 1 Current NDC, 1 package rows 20240601_186a9642-cd73-adfb-e063-6394a90a75c7.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 57 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 79265-8580-1 79265858001 170 g in 1 JAR (79265-8580-1) 170 g 2024-06-01 No No Current