Home NDC 75834-170-01 NIVAGEN ZINC OXIDE
Product NDC 75834-170
Requested package NDC 75834-170-01
11-digit product format 758340170
Labeler code 75834
Product ID 75834-170_9b087880-cd9b-4a0e-be76-dcb0ad2fd11f
Type HUMAN OTC DRUG
Nonproprietary name zinc oxide
Dosage form OINTMENT
Route TOPICAL
Labeler Nivagen Pharmaceuticals, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-05-10
Substance ZINC OXIDE
Active strength 200 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 75834-170 75834-170-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 75834-170 75834-170-01 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 75834-170 75834-170-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 NIVAGEN ZINC OXIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 200 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 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 75834-170-01 NIVAGEN ZINC OXIDE 28.4 g in 1 TUBE OINTMENT 28.4 6 75834-170-02 NIVAGEN ZINC OXIDE 56.7 g in 1 TUBE OINTMENT 56.7 6 75834-170-15 NIVAGEN ZINC OXIDE 425 g in 1 JAR OINTMENT 425 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75834-170 NIVAGEN ZINC OXIDE (ZINC OXIDE) OINTMENT [NIVAGEN PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 3 package rows 20250212_7b42655b-2163-4637-9f5d-1d2efa1bdf1d.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 52 of 68 · 1,346 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 75834-170-01 75834017001 28.4 g in 1 TUBE (75834-170-01) 28.4 g 2018-05-10 0000-00-00 No No Current