Zinc Oxide 20%

Product NDC: 69396-021
11-digit product format: 693960021
Labeler code: 69396
Product ID: 69396-021_521c0f8d-c99e-0b87-e063-6294a90abdbc
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Trifecta Pharmaceuticals USA
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-01-26
Substance: ZINC OXIDE
Active strength: .2 g/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69396-021		I	Inactivated by FDA		2026-10-12
excluded package	package	69396-021	69396-021-01	I	Inactivated by FDA		2026-10-12

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 · 38 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69396-021-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69396-021-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69396-021-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69396-021-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69396-021-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69396-021-01	`cdf11ea48f46…`	`ba0047e9e063…`
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	69396-021-01	`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	69396-021-01	`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	69396-021-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69396-021-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69396-021-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69396-021-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69396-021-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69396-021-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69396-021-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69396-021-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69396-021-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69396-021-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69396-021-01	`8dfbde2a14a4…`	`c9ff85d89658…`

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: Zinc Oxide 20%
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	.2 g/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
63b551fc-7d16-c099-e053-2a91aa0a5f2c	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
69396-021-54	2023-04-24	f386c649-de87-0266-e053-dadaa90a7c1a	Zinc Oxide Ointment 20%
69396-021-54	2023-04-24	f386c649-de87-0266-e053-dadaa90a7c1a	Zinc Oxide Ointment 20%
69396-021-54	2023-01-30	f386c649-de87-0266-e053-dadaa90a7c1a	Zinc Oxide Ointment 20%
69396-021-54	2023-01-30	f386c649-de87-0266-e053-dadaa90a7c1a	Zinc Oxide Ointment 20%
69396-021-02	2021-08-11	ba0f9c33-55c4-a910-e053-dadaa90a0b85	Zinc Oxide Ointment 20%
69396-021-02	2021-08-11	ba0f9c33-55c4-a910-e053-dadaa90a0b85	Zinc Oxide Ointment 20%
69396-021-01	2021-01-29	ba0f9c33-4bbf-a910-e053-dadaa90a0b85	Zinc Oxide Ointment 20%
69396-021-02	2021-01-29	ba0f9c33-55c4-a910-e053-dadaa90a0b85	Zinc Oxide Ointment 20%
69396-021-02	2021-01-29	ba0f9c33-55c4-a910-e053-dadaa90a0b85	Zinc Oxide Ointment 20%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69396-021-54	Zinc Oxide 20%	1 in 1 JAR	OINTMENT	1	9
69396-021-54	Zinc Oxide 20%	454 g in 1 JAR	OINTMENT	454	9
69396-021-02	Zinc Oxide 20%	1 in 1 BOX	OINTMENT	1	7
69396-021-02	Zinc Oxide 20%	60 g in 1 TUBE	OINTMENT	60	7
69396-021-01	Zinc Oxide 20%	28 g in 1 TUBE	OINTMENT	28	2
69396-021-01	Zinc Oxide 20%	1 in 1 BOX	OINTMENT	1	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69396-021-02	GM - Gram	69396-021	198fd2a0-5e55-4d19-b613-89aaa71a1421	1	2022-05-04
69396-021-54	GM - Gram	69396-021	17e82a94-c616-4a21-9e5c-b4da32753d8b	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-021	ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]	8	Current NDC, Legacy NDC, 2 package rows	20241222_8cbe9b1f-fec0-9579-e053-2995a90ac461.zip
69396-021	ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]	4	Current NDC, Legacy NDC, 2 package rows	20250112_63b551fc-7d16-c099-e053-2a91aa0a5f2c.zip
69396-021	ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]	2	Current NDC, Legacy NDC, 2 package rows	20180126_61f5aefe-9b43-a616-e053-2a91aa0acdbc.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 33 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetaphil Soothing Gel Cream	ALLANTOIN	Galderma Laboratories, L.P.	bab404f0-2f7a-4bac-b053-cbdc81c029b5	2025-11-24	Warnings	Exact identifier application number: M016
health beyond VITAMINS AD	PETROLATUM	Nantong Health & Beyond Hygienic Products Inc.	de87da51-cf92-402c-b60f-5f28d1724124	2025-11-23	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM	Medline Industries, LP	00766a7b-797e-dd15-e063-6394a90af9ac	2025-11-20	Warnings	Exact identifier application number: M016
Itch Eraser Sensitive	SODIUM BICARBONATE	Tender Corporation d/b/a Adventure Ready Brands	2250525a-45c2-42ea-e063-6394a90ac001	2025-11-18	Warnings	Exact identifier application number: M016
Moisture Barrier Cream	PETROLATUM, ZINC OXIDE	Derma Sciences Canada Inc.	43e01e22-7872-8e24-e063-6394a90a17ef	2025-11-18	Warnings	Exact identifier application number: M016
terrasil Bed Sore and Pressure Sore Relief	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	d0e4a492-f833-4e92-bd4a-b0a07ce9a69e	2025-11-18	Warnings	Exact identifier application number: M016
terrasil Foot Ulcer and Sore Relief	ALLANTOIN	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	2776080b-3ddb-ad6c-e063-6394a90a93e0	2025-11-18	Warnings	Exact identifier application number: M016
After Bite Kids	SODIUM BICARBONATE	Tender Corporation d/b/a Adventure Ready Brands	226c1420-d771-204f-e063-6294a90af9f6	2025-11-18	Warnings	Exact identifier application number: M016
Petroleum with Cocoa	WHITE PETROLATUM	QUALITY CHOICE (Chain Drug Marketing Association)	280d4bdb-30d3-44f2-9159-3aa9a1de9a5f	2025-11-17	Warnings	Exact identifier application number: M016
After Bite X Tech	SODIUM BICARBONATE	Adventure Ready Brands	e9e49ab4-3e1f-9fd4-e053-2a95a90a775a	2025-11-17	Warnings	Exact identifier application number: M016
Diaper Rash skin protectant	LANOLIN AND PETROLATUM	Universal Distribution Centre LLC	29b5475d-6085-cfe6-e063-6294a90a7e74	2025-11-17	Warnings	Exact identifier application number: M016
DERMOGEN	ZINC OXIDE	KRAMER NOVIS	38e02d1c-c143-4da6-ad32-a3ce2861aac5	2025-11-14	Warnings	Exact identifier application number: M016
Welmedix HomeCare PRO Rapid Relief Rash Cream	PETROLATUM, ZINC OXIDE	Welmedix LLC	4382a6b4-0b1f-0822-e063-6394a90adffc	2025-11-14	Warnings	Exact identifier application number: M016
Petroleum with Cocoa	WHITE PETROLATUM	QUALITY CHOICE (Chain Drug Marketing Association)	086b6563-cb73-4874-aa42-028f5e81b60d	2025-11-13	Warnings	Exact identifier application number: M016
Welmedix HomeCare PRO Fragile Skin Protectant	PETROLATUM	Welmedix LLC	43840785-3640-9813-e063-6394a90a7770	2025-11-13	Warnings	Exact identifier application number: M016
Petroleum Jelly Baby Fresh Scent 3.53oz	PETROLATUM	Rejoice International Corp.	1309926f-ecd9-635e-e063-6294a90aaab3	2025-11-11	Warnings	Exact identifier application number: M016
Petroleum Jelly Fragrance Free 3.53oz	PETROLATUM	Rejoice International Corp.	12f8d9cc-aa77-e034-e063-6394a90a94dd	2025-11-11	Warnings	Exact identifier application number: M016
Petroleum Jelly Cocoa Butter Scent 3.53oz	PETROLATUM	Rejoice International Corp.	1309b15b-5236-6e9f-e063-6294a90afe11	2025-11-11	Warnings	Exact identifier application number: M016
ODLUMIVIE Tremella Revitalizing Cleanser	TREMELLA FUCIFORMIS WHOLE	ODLUMIVIE	435e4736-bcef-c227-e063-6394a90a53d5	2025-11-11	Warnings	Exact identifier application number: M016
ODLUMIVIE Peptide CalmMist	PALMITOYL TRIPEPTIDE-8	ODLUMIVIE	435e6717-5fbf-5cb2-e063-6294a90a40d7	2025-11-11	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	8cbe9b1f-fec0-9579-e053-2995a90ac461	9
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	8cbe9b1f-fec0-9579-e053-2995a90ac461	9
198911	zinc oxide 20 % Topical Ointment	SY	8cbe9b1f-fec0-9579-e053-2995a90ac461	9
198911	zinc oxide 200 MG per GM Topical Ointment	SY	8cbe9b1f-fec0-9579-e053-2995a90ac461	9
198911	ZNO 0.2 MG/MG Topical Ointment	SY	8cbe9b1f-fec0-9579-e053-2995a90ac461	9
198911	zinc oxide 20 % Topical Ointment	PSN	63b551fc-7d16-c099-e053-2a91aa0a5f2c	7
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	63b551fc-7d16-c099-e053-2a91aa0a5f2c	7
198911	zinc oxide 20 % Topical Ointment	SY	63b551fc-7d16-c099-e053-2a91aa0a5f2c	7
198911	zinc oxide 200 MG per GM Topical Ointment	SY	63b551fc-7d16-c099-e053-2a91aa0a5f2c	7
198911	ZNO 0.2 MG/MG Topical Ointment	SY	63b551fc-7d16-c099-e053-2a91aa0a5f2c	7
198911	zinc oxide 20 % Topical Ointment	PSN	61f5aefe-9b43-a616-e053-2a91aa0acdbc	2
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	61f5aefe-9b43-a616-e053-2a91aa0acdbc	2
198911	zinc oxide 20 % Topical Ointment	SY	61f5aefe-9b43-a616-e053-2a91aa0acdbc	2
198911	zinc oxide 200 MG per GM Topical Ointment	SY	61f5aefe-9b43-a616-e053-2a91aa0acdbc	2
198911	ZNO 0.2 MG/MG Topical Ointment	SY	61f5aefe-9b43-a616-e053-2a91aa0acdbc	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69396-021-01	69396002101	28 g in 1 TUBE	28 g					Historical
69396-021-02	69396002102	1 TUBE in 1 BOX (69396-021-02) / 60 g in 1 TUBE	1 tube	2018-01-26	0000-00-00	No	No	Current
69396-021-54	69396002154	1 JAR in 1 JAR (69396-021-54) / 454 g in 1 JAR	1 jar	2019-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zinc Oxide Ointment 20%	Trifecta Pharmaceuticals USA	2026-06-22	HUMAN OTC DRUG LABEL	10
Zinc Oxide Ointment 20%	Trifecta Pharmaceuticals USA	2026-05-18	HUMAN OTC DRUG LABEL	7
Zinc Oxide Ointment 20%	Trifecta Pharmaceuticals USA	2018-01-26	HUMAN OTC DRUG LABEL	2