Home NDC 79265-8576 Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash
Product NDC 79265-8576
11-digit product format 792658576
Labeler code 79265
Product ID 79265-8576_08651e5c-9236-0d03-e063-6294a90a21fc
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form SPRAY
Route TOPICAL
Labeler Babo Botanicals, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-02-01
Substance ZINC OXIDE
Active strength 206 mg/mL
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 206 mg/mL
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 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 79265-8576-1 Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash 89 mL in 1 BOTTLE, SPRAY SPRAY 89 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79265-8576 BABO BOTANICALS SENSITIVE BABY FRAGRANCE FREE DIAPER RASH (ZINC OXIDE) SPRAY [BABO BOTANICALS, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20231024_d66e369e-9b19-b084-e053-2995a90aa259.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 30 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 79265-8576-1 79265857601 89 mL in 1 BOTTLE, SPRAY (79265-8576-1) 89 ml 2022-02-01 0000-00-00 No No Current