Home NDC 79747-009-13 Zinc Oxide 40%
Product NDC 79747-009
Requested package NDC 79747-009-13
11-digit product format 797470009
Labeler code 79747
Product ID 79747-009_3cb8e59e-357b-cb5a-e063-6294a90a9257
Type HUMAN OTC DRUG
Nonproprietary name Diaper Rash Skin Protectent
Dosage form OINTMENT
Route TOPICAL
Labeler ELEEO BRANDS LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-01-30
Substance ZINC OXIDE
Active strength 40 g/100g
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 Zinc Oxide 40%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 40 g/100g
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79747-009-13 Zinc Oxide 40% 113 g in 1 TUBE OINTMENT 113 2 79747-009-13 Zinc Oxide 40% 1 in 1 BOX OINTMENT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79747-009 ZINC OXIDE 40% (DIAPER RASH SKIN PROTECTENT) OINTMENT [ELEEO BRANDS LLC] 1 Current NDC, 2 package rows 20241220_2992285b-bcdb-c0da-e063-6294a90ac650.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 · 1,350 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 79747-009-13 79747000913 1 TUBE in 1 BOX (79747-009-13) / 113 g in 1 TUBE 1 tube 2024-12-18 No No Current