Home NDC 85403-208 Bio H Plus Daily Defense And Revitalize
Product NDC 85403-208
11-digit product format 854030208
Labeler code 85403
Product ID 85403-208_4603669d-75df-2783-e063-6394a90a9dac
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler BIOHEALTH PLUS LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-10-20
Substance ZINC OXIDE
Active strength 160 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
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 Bio H Plus Daily Defense And Revitalize
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 160 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 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 85403-208-15 Bio H Plus Daily Defense And Revitalize 1.5 g in 1 PACKET CREAM 1.5 2 85403-208-50 Bio H Plus Daily Defense And Revitalize 50 g in 1 BOTTLE, PUMP CREAM 50 2
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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85403-208-15 85403020815 1.5 g in 1 PACKET (85403-208-15) 1.5 g 2021-10-20 Yes No Current 85403-208-50 85403020850 50 g in 1 BOTTLE, PUMP (85403-208-50) 50 g 2021-10-20 No No Current