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		2026-10-05
excluded package	package	69396-021	69396-021-01	I	Inactivated by FDA		2026-10-05

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 4 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petroleum Jelly, Lil Drug Store	PETROLATUM JELLY	Lil' Drug Store Products, Inc.	5862af40-97e2-d792-e063-6394a90a0f1a	2026-08-06	Warnings	Exact identifier application number: M016
AOAO RAPID ACNE RELIEF	SALICYLIC ACID,BENZOYL PEROXIDE	Guangzhou Senmai Biotechnology Co.,Ltd.	586df874-0f71-ed46-e063-6294a90a0a8e	2026-08-06	Warnings	Exact identifier application number: M016
Dealmed Vitamins A and D	WHITE PETROLATUM	Dealmed Medical Supplies, LLC.	d6584809-b438-4b2c-ab37-522e0dbef470	2026-08-05	Warnings	Exact identifier application number: M016
Dealmed Vitamins A and D	PETROLATUM	Dealmed Medical Supplies, LLC.	84afe4ae-f9e8-406f-9fbe-f413975f86eb	2026-08-05	Warnings	Exact identifier application number: M016
Petroleum Jelly	PETROLATUM	Walgreens	1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f5	2026-08-04	Warnings	Exact identifier application number: M016
Nail Treatment Repairing Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	57b8b3e5-88be-3a91-e063-6294a90a05be	2026-08-03	Warnings	Exact identifier application number: M016
PROCURE	ZINC OXIDE	TWIN MED, LLC	e68ae97e-668e-31c2-e053-2995a90ab4d3	2026-08-03	Warnings	Exact identifier application number: M016
PROCURE VITAMIN A AND D Skin Protectant	PETROLATUM	TWIN MED, LLC	bbbca68e-1b65-49b1-a5fa-ed4da55d05e3	2026-08-03	Warnings	Exact identifier application number: M016
procure	PETROLATUM	TWIN MED, LLC	32520d8f-91ee-47a1-9129-bf0746791f4b	2026-08-03	Warnings	Exact identifier application number: M016
ProCure HydroShield	PETROLATUM 44.28%	Twin Med LLC	3ab7bfb2-bbcf-0822-e063-6294a90af084	2026-08-03	Warnings	Exact identifier application number: M016
456 Acne Relief Cream	NIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOT	Guangzhou Senmai Biotechnology Co.,Ltd.	5830fd36-0613-1980-e063-6294a90adfb7	2026-08-03	Warnings	Exact identifier application number: M016
Crogooe Skin Relief Cream	COLLOIDAL OATMEAL	Guangdong Outeli Biotechnology Co., Ltd.	57f9b3e8-25d3-2b20-e063-6394a90aaea5	2026-08-01	Warnings	Exact identifier application number: M016
First Aid Beauty Sensitive Skin Bestsellers Kit	COLLOIDAL OATMEAL	JCS Global Distribution, Inc.	57c3556a-aad3-3e65-e063-6394a90ab689	2026-07-29	Warnings	Exact identifier application number: M016
DERMFREE INSECT BITE RELIEF	SODIUM BICARBONATE 5% INSECT BITE RELIEF	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5794886c-0d74-9f35-e063-6394a90a27d8	2026-07-27	Warnings	Exact identifier application number: M016
OKeeffes Lip Repair SEAL and HEAL	PETROLATUM	The Gorilla Glue Company/O'Keeffe's Company	55f66f54-da39-76c7-e063-6394a90aeda9	2026-07-27	Warnings	Exact identifier application number: M016
ATTITUDE Baby Leaves Diaper cream - Unscented	ZINC OXIDE	9055-7588 Quebec Inc. (Attitude)	579aa481-f8ec-b263-e063-6394a90a7754	2026-07-27	Warnings	Exact identifier application number: M016
Boo Boo Magic Diaper Rash Creamy	ZINC OXIDE	Alboo Brands LLC	5114aff8-adde-e610-e063-6294a90a77ea	2026-07-27	Warnings	Exact identifier application number: M016
PrevaDRM Vitamin Repair	SKIN PROTECTANT	Sion Brands LLC	579e4639-a742-1901-e063-6294a90a2d45	2026-07-27	Warnings	Exact identifier application number: M016
Hello Bello Diaper Rash Cream	ZINC OXIDE	Topiderm, Inc.	e158ba31-e159-4624-a490-fe70baaf4a39	2026-07-24	Warnings	Exact identifier application number: M016
Gethorey Vein Target Microneedle Patch	ALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57593145-a874-15d9-e063-6294a90a77d9	2026-07-24	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