Home NDC 68016-159 Zinc Oxide 20%
Product NDC 68016-159
11-digit product format 680160159
Labeler code 68016
Product ID 68016-159_29b7387b-ad70-3a11-e063-6394a90a6a15
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form OINTMENT
Route TOPICAL
Labeler Pharmacy Value Alliance, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-07-19
Substance ZINC OXIDE
Active strength .2 g/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 Zinc Oxide 20%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE .2 g/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 198911 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68016-159-02 Zinc Oxide 20% 1 in 1 BOX OINTMENT 1 5 68016-159-02 Zinc Oxide 20% 57 g in 1 TUBE OINTMENT 57 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-159 ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [PHARMACY VALUE ALLIANCE, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241222_38018e3f-3778-01d1-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 28 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 68016-159-02 68016015902 1 TUBE in 1 BOX (68016-159-02) / 57 g in 1 TUBE 1 tube 2016-07-19 0000-00-00 No No Current