Home NDC 81929-002 Vitacilina Bebe Diaper Rash
Product NDC 81929-002
11-digit product format 819290002
Labeler code 81929
Product ID 81929-002_3bc68c66-c125-1bcc-e063-6394a90a0e63
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form OINTMENT
Route TOPICAL
Labeler Taisho Pharmaceutical California Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-07-01
Marketing end 2027-10-17
Substance ZINC OXIDE
Active strength 400 mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
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 Vitacilina Bebe Diaper Rash Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 400 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 244638 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 81929-002-01 Vitacilina Bebe Diaper Rash 50 g in 1 TUBE OINTMENT 50 3 81929-002-01 Vitacilina Bebe Diaper Rash 1 in 1 CARTON OINTMENT 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81929-002 VITACILINA BEBE DIAPER RASH (ZINC OXIDE) OINTMENT [TAISHO PHARMACEUTICAL CALIFORNIA INC.] 2 Current NDC, Legacy NDC, 2 package rows 20231111_6701e929-700e-40a4-9117-81e36577bfe1.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 Marketing end Sample Exclude flag Status 81929-002-01 81929000201 1 TUBE in 1 CARTON (81929-002-01) / 50 g in 1 TUBE 1 tube 2022-07-01 2027-10-17 No No Current