Home NDC 61649-110 BIO SPECTRA
Product NDC 61649-110
11-digit product format 616490110
Labeler code 61649
Product ID 61649-110_273701b7-3462-bd2d-e063-6294a90a1a94
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler 9055-7588 Quebec Inc. DBA Attitude
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-11
Substance ZINC OXIDE
Active strength 20 g/100g
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 SPECTRA
Brand name suffix ATTITUDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61649-110-15 BIO SPECTRAATTITUDE 150 g in 1 TUBE CREAM 150 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61649-110 BIO SPECTRA ATTITUDE (ZINC OXIDE) CREAM [9055-7588 QUEBEC INC. DBA ATTITUDE] 5 Current NDC, Legacy NDC, 1 package rows 20241120_954713fe-c84c-41b4-913d-3507ed91e55d.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 26 of 357 · 7,139 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 61649-110-15 61649011015 150 g in 1 TUBE (61649-110-15) 150 g 2023-12-11 0000-00-00 No No Current