Zinc Oxide 20%

Product NDC: 69396-021
Requested package NDC: 69396-021-54
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

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 7 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sosnowskis Magic Healing Multi action	CAMPHOR AND COLLOIDAL OATMEAL	Herstat (USA) Inc.	38cd8f11-7264-a004-e063-6294a90a3a1b	2026-07-03	Warnings	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Publix Super Markets, Inc.	c94b5574-3fd7-48a8-94ef-db5d7184fa10	2026-07-02	Warnings, Adverse reactions	Exact identifier application number: M016
Drs. Pharmacy Baby Healing	ZINC OXIDE	OL PHARMA TECH, LLC Drs PHARMACY	55a6981c-1b32-f448-e063-6294a90ac6d8	2026-07-02	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	558d239e-b0cf-c145-e063-6294a90a8a8b	2026-07-01	Warnings	Exact identifier application number: M016
DIMETHICONE SKIN PROTECTANT	DIMETHICONE	VIVE HEALTH LLC	5591a321-4831-1844-e063-6394a90a12d1	2026-07-01	Warnings	Exact identifier application number: M016
Drs. Pharmacy healing	PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	55947cd9-ca25-0844-e063-6294a90a381f	2026-07-01	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	55833e0f-d184-16a2-e063-6394a90acfd3	2026-06-30	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Summer Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55664a0f-7d46-f002-e063-6394a90a2dc7	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5566bce3-fc49-5ef4-e063-6294a90abc7a	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet Plum	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5568ada5-3ae6-3366-e063-6294a90a7119	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted Coconut	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55698d88-aae7-c46c-e063-6394a90ad0ac	2026-06-29	Warnings	Exact identifier application number: M016
Earth Baby Diaper Rash Cream	ZINC OXIDE	Earth Baby, Inc	42c5cf9a-0a35-5681-e054-00144ff8d46c	2026-06-28	Warnings	Exact identifier application number: M016
ORLASKIN HYDROGEL EYE MASK	ALLANTOIN	Guangzhou Yapheon Health Industry Co., Ltd.	552d072b-396f-c88a-e063-6294a90aabcd	2026-06-26	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM	Medline Industries, LP	3c442890-733d-8175-e063-6294a90a8b1c	2026-06-24	Warnings	Exact identifier application number: M016
MOROVAN	ESTRIOL	HONG KONG UNORDERED TRADING CO., LIMITED	54fa4308-44a4-e9dd-e063-6394a90a0cd7	2026-06-24	Warnings	Exact identifier application number: M016
EELHOE Sleep Aid Patch	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	550b0494-ca6d-c897-e063-6394a90a8751	2026-06-24	Warnings	Exact identifier application number: M016
Hair Regrowth Liquid	GLYCERIN	Shantou Woodsleep Biotechnology Co., Ltd.	54e662e7-9c63-ad6b-e063-6294a90a1b8d	2026-06-23	Warnings	Exact identifier application number: M016
RoyceDerm Eczema Relief Body Wash	COLLOIDAL OATMEAL 2%	RoyceDerm LLC	54e74eb4-1b42-a748-e063-6394a90aeb16	2026-06-23	Warnings	Exact identifier application number: M016
Comfort Shield Barrier	DIMETHICONE	Sage Products LLC	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	2026-06-23	Warnings	Exact identifier application number: M016
CLEAR ANTI ITCH	PRAMOXINE HCL, ZINC ACETATE LOTION	H E B	54f04056-d805-8c62-e063-6394a90ab740	2026-06-23	Warnings, Adverse reactions	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
69396-021-54	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