Home NDC 58809-375 Z-Bum
Product NDC 58809-375
11-digit product format 588090375
Labeler code 58809
Product ID 58809-375_47e330be-1731-f8ab-e063-6294a90aa44e
Type HUMAN OTC DRUG
Nonproprietary name Diaper Rash Cream
Dosage form CREAM
Route TOPICAL
Labeler GM Pharmaceuticals, Inc
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-12-01
Substance ZINC OXIDE
Active strength 22 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 Z-Bum
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 22 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1734937 Internal RxNorm lookup 1734942 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 58809-375-04 Z-Bum 113 g in 1 TUBE CREAM 113 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58809-375 Z-BUM (DIAPER RASH CREAM) CREAM [GM PHARMACEUTICALS, INC] 10 Current NDC, Legacy NDC, 1 package rows 20240328_2a36f396-3a30-3f3f-e054-00144ff8d46c.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 59 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 Marketing end Sample Exclude flag Status 58809-375-04 58809037504 113 g in 1 TUBE (58809-375-04) 113 g 2015-12-01 0000-00-00 No No Current