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 63 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydro Gel	GLYCERIN 20%	Trifecta Pharmaceuticals USA LLC	02e8e5d0-7844-39fe-e063-6394a90a57e1	2024-01-19	Warnings	Exact identifier application number: M016
White Petrolatum	WHITE PETROLATUM	Sled Distribution, LLC	e73a4b7a-7b27-abfc-e053-2995a90a35c2	2024-01-15	Warnings	Exact identifier application number: M016
Sunmark Caldiphen	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services	4f4d4c54-64b5-4e20-bed0-c7fb470b8434	2024-01-12	Warnings	Exact identifier application number: M016
EIGHT HOUR NIGHT	DIMETHICONE	REVLON	b3b277f9-565a-636c-e053-2995a90a94d2	2024-01-12	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Eczema Relief Creamy	OATMEAL	L'Oreal USA Products Inc	bcf7b985-6875-4033-a412-1bb6d3afa6d8	2024-01-01	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Healing	PETROLATUM	L'Oreal USA Products Inc.	1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95	2023-12-31	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Baby Healing	PETROLATUM	L'Oreal USA Products Inc.	fe665bbc-1172-4f59-acc6-8d5c179693b6	2023-12-31	Warnings	Exact identifier application number: M016
Quality Choice Anti-Itch Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Chain Drug Market Association	e3c0c46d-3d85-411d-a543-009064cdd19e	2023-12-28	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Therapeutic Hand	DIMETHICONE	L'Oreal USA Products Inc	7fe49112-4180-415c-a380-768a8d6b2185	2023-12-28	Warnings	Exact identifier application number: M016
Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Pharma Nobis, LLC	e42fccc2-1b4e-e7f3-e053-2a95a90aef39	2023-12-26	Warnings	Exact identifier application number: M016
Calamine Phenolated Topical Suspension	CALAMINE AND ZINC OXIDE AND PHENOL	Pharma Nobis, LLC	e42fbdcc-3291-7761-e053-2995a90a7172	2023-12-26	Warnings	Exact identifier application number: M016
Humco Calagesic	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Pharma Nobis, LLC	e42fb807-8cb4-ed25-e053-2995a90a6780	2023-12-26	Warnings	Exact identifier application number: M016
Leader Calamine Plus	ZINC OXIDE LOTION	Cardinal Health, 110 dba Leader	81f29789-f794-1e64-e053-2a91aa0ac85e	2023-12-22	Warnings	Exact identifier application number: M016
CVS Calamine Plus	ZINC OXIDE	CVS Pharmacy	b90cd214-d44a-4458-876d-59cc0795226d	2023-12-22	Warnings	Exact identifier application number: M016
Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Pharma Nobis, LLC	e42f0bd6-3ad3-7e07-e053-2995a90a564a	2023-12-22	Warnings	Exact identifier application number: M016
DDM Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Discount Drug Mart	5d53685b-ca4c-35c1-e053-2a91aa0aff6e	2023-12-20	Warnings	Exact identifier application number: M016
DDM Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Discount Drug Mart	5d537a11-049e-0a8d-e053-2a91aa0aa0c3	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Strategic Sourcing Services LLC	349ea07d-79bc-46f3-9d60-85b40db51bbb	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	2a1d9b27-0bd4-4475-8218-ba0f5560a969	2023-12-20	Warnings	Exact identifier application number: M016
Quality Choice Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Chain Drug Market Association	62fe653f-e861-472b-b193-4fdd9d25de8d	2023-12-20	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