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 56 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aveeno Daily Moisturizing	DIMETHICONE	Kenvue Brands LLC	70593b0c-c41b-4294-9bfa-42003ba1e3e4	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Baby Calming Comfort	DIMETHICONE	Kenvue Brands LLC	029fbae2-06ad-4fe9-b542-834686c5cb97	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Skin Relief Overnight	DIMETHICONE	Kenvue Brands LLC	e7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c	2024-11-05	Warnings	Exact identifier application number: M016
Quality Choice Diaper Rash	ZINC OXIDE	Chain Drug Marketing Association Inc.	262e7eac-4b44-f224-e063-6394a90a4f59	2024-11-05	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE	Chain Drug Marketing Association Inc.	262f8cab-c7b8-b07e-e063-6294a90a1289	2024-11-05	Warnings	Exact identifier application number: M016
ECZEMA	OATMEAL	ORGANIC & SUSTAINABLE BEAUTY	926706b5-0a08-4604-b5ad-3b3ddfd7f02d	2024-11-05	Warnings	Exact identifier application number: M016
Walgreens Eczema Relief Body Skin Protectant	OATMEAL	Walgreen Company	b2eebc2f-addd-4822-b224-04bd5f450653	2024-11-05	Warnings	Exact identifier application number: M016
ECZEMA	OATMEAL	ORGANIC & SUSTAINABLE BEAUTY	81eb3df4-5beb-45aa-82ca-e8b4b37e45f4	2024-11-05	Warnings, Adverse reactions	Exact identifier application number: M016
Aveeno Baby Calming Comfort	DIMETHICONE	Kenvue Brands LLC	567b1481-b783-45f9-af38-5630c9edf044	2024-11-01	Warnings	Exact identifier application number: M016
ZO Skin Health Astringent Solution	ALUMINUM ACETATE	ZO Skin Health, Inc.	cb801d7e-52ad-6c16-e053-2a95a90a7a1f	2024-10-31	Warnings	Exact identifier application number: M016
ZINC OXIDE PHARMA	ZINC OXIDE	ALLIED TRADE LINK LLC	1b580bf6-f217-5c0f-e063-6294a90a012e	2024-10-29	Warnings	Exact identifier application number: M016
Dove DermaSeries Eczema Relief Soothing Body	COLLOIDAL OATMEAL	Conopco, Inc. d/b/a/ Unilever	59f737f6-dd3f-4b63-b13e-2345cb9a951a	2024-10-24	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER SHEA BUTTER	Conopco Inc. d/b/a/ Unilever	a735d885-bacd-0f5c-e053-2a95a90ad14a	2024-10-24	Warnings	Exact identifier application number: M016
Baby Dove	8H MOISTURIZATION HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	b8dc481c-1ac3-2d63-e053-2a95a90a44f5	2024-10-24	Warnings	Exact identifier application number: M016
Vaseline	CLINICAL CARE HAND SANITIZER LOTION	Conopco Inc. d/b/a/ Unilever	ba0aa323-8887-597f-e053-2995a90a2077	2024-10-24	Warnings	Exact identifier application number: M016
Dove	NOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATION	Conopco Inc. d/b/a/ Unilever	d1039316-3ca8-90f8-e053-2995a90a2061	2024-10-24	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER LAVENDER	Conopco Inc. d/b/a/ Unilever	a736838b-b559-f066-e053-2995a90a90f5	2024-10-24	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2.5oz	ZINC OXIDE	Rejoice International Corp.	130d94d8-ad98-d61f-e063-6294a90a76b0	2024-10-21	Warnings	Exact identifier application number: M016
HARMON DAILY MOISTURZIER	DIMETHICONE	HARMON STORES, INC.	bda5dbaa-5d62-4a40-ba55-e2066e8ca1c7	2024-10-21	Warnings	Exact identifier application number: M016
Dimethicone	BODY SHIELD	McKesson	8febb45d-a200-702c-e053-2995a90a3e62	2024-10-18	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