Home NDC 80641-014 Mineral Shake
Product NDC 80641-014
11-digit product format 806410014
Labeler code 80641
Product ID 80641-014_138cbcd0-ac5c-4e14-e063-6394a90af42c
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Vacation Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-07
Substance ZINC OXIDE
Active strength 20.5 g/100mL
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 Mineral Shake
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20.5 g/100mL
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 80641-014-60 Mineral Shake 15 mL in 1 BOTTLE LOTION 15 3 80641-014-75 Mineral Shake 50 mL in 1 BOTTLE LOTION 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80641-014 MINERAL SHAKE (ZINC OXIDE) LOTION [VACATION INC.] 3 Current NDC, 2 package rows 20240315_131b7e65-7155-f925-e063-6394a90a1d7a.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 81 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 80641-014-60 80641001460 15 mL in 1 BOTTLE (80641-014-60) 15 ml 2024-03-07 No No Current 80641-014-75 80641001475 50 mL in 1 BOTTLE (80641-014-75) 50 ml 2024-03-07 No No Current