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 49 of 68 · 1,346 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bamboobies Diaper Rash ZINC OXIDE 15% Derma Care Research Labs, LLC 0411f5e3-03d2-c512-e063-6394a90a37d3 2024-12-19 Warnings Exact identifier application number: M016 Maximum Strength Medicated Foot Powder MEDICATED FOOT POWDER Jell Pharmaceuticals Pvt. Ltd. cdaae985-5363-e9d2-e053-2995a90a2682 2024-12-18 Warnings Exact identifier application number: M016 BABY FRESH SCENT PETROLEUM WHITE PETROLEUM Jell Pharmaceuticals Pvt Ltd. d80d21cf-9463-7184-e053-2995a90a23f3 2024-12-18 Warnings Exact identifier application number: M016 Health Smart Baby Petroleum WHITE PETROLEUM Home Smart Products edd9d018-c2c9-4a9a-b727-0a92cd463c02 2024-12-18 Warnings Exact identifier application number: M016 Health Smart Cocoa Butter Petroleum WHITE PETROLEUM Home Smart Products a65c8267-d34f-4542-a7ca-5180e860a03d 2024-12-18 Warnings Exact identifier application number: M016 Princess Petroleum WHITE PETROLATUM Ultra Distributors Inc. 6d9c92bf-9263-40a4-acac-5c3f0b08c69d 2024-12-18 Warnings Exact identifier application number: M016 Meijer Petroleum Jelly WHITE PETROLATUM Meijer Distribution, Inc b299cf2a-2c6a-68f4-e053-2995a90a5bd7 2024-12-18 Warnings Exact identifier application number: M016 Foster and Thrive Caldyphen CALAMINE AND PRAMOXINE HYDROCHLORIDE Strategic Sourcing Services, LLC 29945734-4ea6-b702-e063-6294a90ae6f2 2024-12-18 Warnings Exact identifier application number: M016 Foster and Thrive Caldyphen Clear PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE Strategic Sourcing Services, LLC 29946912-9794-8a8e-e063-6394a90a279e 2024-12-18 Warnings Exact identifier application number: M016 Caring Mills Petroleum Jelly WHITE PETROLATUM Veridian Healthcare fbbfa780-0e2b-1874-e053-6394a90a5eeb 2024-12-18 Warnings Exact identifier application number: M016 Serawise Eczema Rescue OATMEAL DrAnaMaria.com LLC e805866a-2349-4b86-bc83-a7c859cb9403 2024-12-18 Warnings Exact identifier application number: M016 TheraCare Petroleum Jelly WHITE PETROLATUM Veridian Healthcare d6fad49b-8a49-7f7c-e053-2a95a90ae638 2024-12-18 Warnings Exact identifier application number: M016 Shea Butter Petroleum Jelly PETROLATUM JELLY Walgreens e35d913e-2195-4e3d-ae38-f010317140fd 2024-12-17 Warnings Exact identifier application number: M016 Jell Pharmaceuticals Vitamin A D PETROLATUM Jell Pharmaceuticals Pvt. Ltd. 6ab8ba54-3679-4fd0-a876-cb89aace96ca 2024-12-17 Warnings Exact identifier application number: M016 Shea Butter Petroleum Jelly PETROLATUM JELLY Jell Pharmaceuticals Pvt. Ltd. cd848f33-e863-d3af-e053-2a95a90a45b1 2024-12-17 Warnings Exact identifier application number: M016 Softlips Cherry, Raspberry, Vanilla DIMETHICONE The Mentholatum Company b7b2f64e-27b4-4c71-95cf-78b37540f975 2024-12-17 Warnings Exact identifier application number: M016 Softlips Tropical Coconut DIMETHICONE The Mentholatum Company 1203ea70-dc1a-4439-a230-bd3fc45f75f5 2024-12-17 Warnings Exact identifier application number: M016 Softlips Tropical Coconut Peach Passion DIMETHICONE The Mentholatum Company 11f619e7-4a58-45e4-8f4a-fe358832ab64 2024-12-17 Warnings Exact identifier application number: M016 Softlips Watermelon, Tropical Coconut, Peach Passion DIMETHICONE The Mentholatum Company e9212502-909a-4184-905e-f31a53602c3b 2024-12-17 Warnings Exact identifier application number: M016 Softlips Watermelon DIMETHICONE The Mentholatum Company e32d738e-e0af-4f17-a753-bdc7938b1684 2024-12-17 Warnings Exact identifier application number: M016
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