NIVAGEN ZINC OXIDE

Product NDC: 75834-170
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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75834-170-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75834-170-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75834-170-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75834-170-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75834-170-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75834-170-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75834-170-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75834-170-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75834-170-01	`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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7b42655b-2163-4637-9f5d-1d2efa1bdf1d	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
75834-170-01	2025-02-10	Zinc Oxide Ointment USP Drug Facts
75834-170-02	2025-02-10	Zinc Oxide Ointment USP Drug Facts
75834-170-15	2025-02-10	Zinc Oxide Ointment USP Drug Facts
75834-170-01	2025-01-30	Zinc Oxide Ointment USP Drug Facts
75834-170-02	2025-01-30	Zinc Oxide Ointment USP Drug Facts
75834-170-15	2025-01-30	Zinc Oxide Ointment USP Drug Facts
75834-170-01	2022-02-14	Zinc Oxide Ointment USP Drug Facts
75834-170-02	2022-02-14	Zinc Oxide Ointment USP Drug Facts
75834-170-15	2022-02-14	Zinc Oxide Ointment USP Drug Facts
75834-170-01	2022-01-28	Zinc Oxide Ointment USP Drug Facts
75834-170-02	2022-01-28	Zinc Oxide Ointment USP Drug Facts
75834-170-15	2022-01-28	Zinc Oxide Ointment USP Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75834-170-01	GM - Gram	75834-170	23ca029a-7091-40a4-a489-8313dd3bb724	1	2018-09-05
75834-170-02	GM - Gram	75834-170	f8f42b83-1876-4fba-8afb-3e5afc596041	1	2018-09-05
75834-170-15	GM - Gram	75834-170	f19b2880-a7bd-4f80-8848-45964e811755	1	2018-11-06

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 3 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DawnMist White Petrolatum	WHITE PETROLATUM	Dukal LLC	598e9d46-6450-af60-e063-6394a90a3a6b	2026-08-21	Warnings	Exact identifier application number: M016
MUSTELA Diaper Rash 1 2 3	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	163f388e-849d-4b7e-93c1-9045d77a9ec2	2026-08-21	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	0073de92-585d-e01a-e063-6394a90a2ec2	2026-08-21	Warnings	Exact identifier application number: M016
Mederma PM	DIMETHICONE	L Perrigo Company	8c728904-28f4-4333-a9ea-20996fd1b007	2026-08-21	Warnings	Exact identifier application number: M016
Earths Care Hemorrhoid Relief	WITCH HAZEL AND MENTHOL, UNSPECIFIED FORM	DLC Laboratories, Inc.	e860d65b-126d-4d77-8003-9d1381849ab5	2026-08-20	Warnings	Exact identifier application number: M016
ClaraVie	PETROLATUM	Gentell LLC	596987e4-4205-b911-e063-6294a90aa570	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	ZINC OXIDE	Gentell LLC	596abd98-17d7-2a22-e063-6294a90af57d	2026-08-19	Warnings	Exact identifier application number: M016
Claravie Skin Repair Cream	DIMETHICONE	Gentell LLC	596ae269-172e-aef5-e063-6394a90a4e2a	2026-08-19	Warnings	Exact identifier application number: M016
Claravie	LANOLIN	Gentell LLC	596c1b73-e34d-c97d-e063-6394a90ada1b	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	MENTHOL, ZINC OXIDE	Gentell LLC	596c467f-a056-ea78-e063-6394a90a79f2	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	LANOLIN	Gentell LLC	596fe32d-be34-0635-e063-6394a90a2fc0	2026-08-19	Warnings	Exact identifier application number: M016
Medpride	ZINC OXIDE	Shield Line LLC	e2689cae-e347-4c0b-825b-6281a0b7c2f1	2026-08-18	Warnings	Exact identifier application number: M016
Eczema Skin Relief Cream	COLLOIDAL OATMEAL	CVS Health	98fac854-f7b0-4c6e-888d-1bdc6b9323b9	2026-08-17	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	ADUSA Distribution, LLC	5940399c-31e3-6d51-e063-6294a90a8e7c	2026-08-17	Warnings, Adverse reactions	Exact identifier application number: M016
Intimate CareGel	HYALURONIC ACID	Guangzhou Yilong Cosmetics.,Ltd	5918d204-52db-e6d0-e063-6394a90ab78c	2026-08-14	Warnings	Exact identifier application number: M016
TENA Proskin protective cream	ZINC OXIDE	Essity HMS North America Inc.	b840377f-a297-4aff-900e-7ea8b7c98717	2026-08-13	Warnings, Adverse reactions	Exact identifier application number: M016
Medline	WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	087d66ff-1a8c-dcb2-e063-6294a90a2f8c	2026-08-11	Warnings	Exact identifier application number: M016
Nail Renewal Liquid	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	581f7192-fc17-a706-e063-6394a90a3ffa	2026-08-11	Warnings	Exact identifier application number: M016
Intertrigo Relief Cream	GLYCERIN	Shantou South Moon Biotechnology Co., Ltd.	587220c9-0ae9-3438-e063-6394a90a0a86	2026-08-07	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	The Kroger Co.	9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198911	zinc oxide 20 % Topical Ointment	PSN	7b42655b-2163-4637-9f5d-1d2efa1bdf1d	6
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	7b42655b-2163-4637-9f5d-1d2efa1bdf1d	6
198911	zinc oxide 20 % Topical Ointment	SY	7b42655b-2163-4637-9f5d-1d2efa1bdf1d	6
198911	zinc oxide 200 MG per GM Topical Ointment	SY	7b42655b-2163-4637-9f5d-1d2efa1bdf1d	6
198911	ZNO 0.2 MG/MG Topical Ointment	SY	7b42655b-2163-4637-9f5d-1d2efa1bdf1d	6

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
75834-170-02	75834017002	56.7 g in 1 TUBE (75834-170-02)	56.7 g	2018-05-10	0000-00-00	No	No	Current
75834-170-15	75834017015	425 g in 1 JAR (75834-170-15)	425 g	2018-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zinc Oxide Ointment USP Drug Facts	Nivagen Pharmaceuticals, Inc.	2025-02-03	Human OTC Drug Label	6