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 17 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Old East Main Co.	91df1434-bce6-4c6e-beee-cb5ec1cc8fff	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Old East Main Co.	cf916191-1de2-4305-b783-9e074c1ad94b	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Eczema Relief	COLLOIDAL OATMEAL	Old East Main Co.	b2dba027-c295-4a41-8d30-144904e1aa34	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Eczema Therapy	COLLOIDAL OATMEAL	Old East Main Co.	9720e2ad-1bcf-4023-8e92-22a962df3aad	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Chain Drug Marketing Association	86ff4875-9007-4b7b-8f46-16cbd475d4bb	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Chain Drug Marketing Association	1ff6bd85-3658-47ea-b6ca-0eb5d8dbb693	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Chain Drug Marketing Association	6c848b98-f01c-40f2-a9aa-2af76cb370c8	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	The Kroger Co.	fcffbe1f-79b8-451a-9384-19533b81d8c8	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	The Kroger Co.	d2095c7b-61ca-40d3-bbf1-04bed4dd789c	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	The Kroger Co.	ea8b186c-82d5-4552-bcce-03e56023ea99	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash Cream	ZINC OXIDE	Smalls Brand LLC DBA Roe Wellness	4bd29285-29b4-5d57-e063-6294a90af481	2026-02-27	Warnings	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Walmart Inc.	5893801a-25e1-4750-a55b-d9cddd3f1284	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Walmart Inc.	320bcbd3-9e91-437f-99c5-066f880a4b32	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Skin Protectant	PETROLATUM	Walmart Inc.	eb836922-f467-42ab-a6e7-b787d97e6c17	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Walmart Inc.	aa7dbf7f-50be-475b-8140-68be3fa93507	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
White Petrolatum	WHITE PETROLATUM	Walmart Inc.	176d7711-7c4f-4319-91af-0aba1260c412	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Soothing Moisturizing	COLLOIDAL OATMEAL	Walmart Inc.	2d813455-c268-4c6d-9952-eaf0e0007d90	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Rapid Repair Healing Cream	ALLANTOIN, DIMETHICONE	June Jacobs Labs LLC	186c13be-5e41-b9c9-e063-6294a90ad574	2026-02-26	Warnings	Exact identifier application number: M016
Lanashield	LANOLIN	Dynarex Corporation	94b277dc-6512-4d36-8485-8ea510097428	2026-02-26	Warnings	Exact identifier application number: M016
GLADSKIN ECZEMACT ECZEMA	COLLOIDAL OATMEAL	Micreos North America, Inc.	06f9af75-c5ff-d37b-e063-6394a90a4f6c	2026-02-25	Warnings	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