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 26 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DERMATITIS FACE BALM	COLLOIDAL OATMEAL	Skinfix, Inc.	86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6	2026-01-08	Warnings	Exact identifier application number: M016
First Aid Beauty Dry Skin Rescue Kit 5x Hydration Power	COLLOIDAL OATMEAL	JCS Global Distribution, Inc.	47d06283-21cd-4a69-e063-6294a90adb05	2026-01-07	Warnings	Exact identifier application number: M016
DE LA CRUZ DIAPER RASH	ALLANTOIN, PETROLATUM, AND ZINC OXIDE	DLC Laboratories, Inc.	5949aa0f-a7cb-453c-81fd-9fa24653a452	2026-01-07	Warnings	Exact identifier application number: M016
Thera Wise Natural Hemorrhoidal	WITCH HAZEL	Derma Wise Skin Care Ltd.	a29fb680-cfc8-4a7b-9970-563fa0e2bed6	2026-01-06	Warnings	Exact identifier application number: M016
Sky and Sol SPF25 Lip Balm	SKY AND SOL SPF25 LIP BALM	Guangzhou Fantesy Biotechnology Co.,Ltd	1f37c0c3-6443-60a3-e063-6394a90a596f	2026-01-05	Warnings	Exact identifier application number: M016
Remedy Essentials	WHITE PETROLATUM,ZINC OXIDE	Medline Industries, LP	42a033d6-782b-2d7f-e054-00144ff8d46c	2026-01-05	Warnings	Exact identifier application number: M016
BUNUSS Estriol Face	ESTRIOL	Jiashen International Trade Limited	478b5690-038a-ba1c-e063-6394a90a3ad6	2026-01-04	Warnings	Exact identifier application number: M016
Skin Protectant for Babies and kids	SKIN PROTECTANT OINTMENT	Neilmed Pharmaceuticals Inc.	448b70db-ca81-db7b-e063-6294a90a5f0d	2026-01-02	Warnings	Exact identifier application number: M016
Puriya Eczema Cream	COLLOIDAL OATMEAL	IPC Republic, Inc.	24ac044e-13fa-5ff6-e063-6294a90a9985	2026-01-01	Warnings	Exact identifier application number: M016
Scarzen	DIMETHICONE	Village Pharma LLC	1550f4e5-22e2-491f-8184-de65da7234e6	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU 100 PURE PETROLEUM	WHITE PETROLATUM	JC SALES	48f74b99-7ead-b0d0-e063-6394a90a4929	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	JC SALES	48f79c2a-b314-169f-e063-6294a90a576e	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	JC SALES	490ac0a6-eac0-a74f-e063-6394a90a84ed	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM COCOA BUTTER	WHITE PETROLATUM	JC SALES	490af001-c78c-e2d2-e063-6394a90abdb0	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU 100 PURE PETROLEUM	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	4946ac1a-f475-fbb1-e063-6394a90a30bc	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	4946d1b7-ae1b-1e73-e063-6394a90a1ed2	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM BABY FRESH SCENT	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	49471d77-303a-8536-e063-6394a90aea51	2026-01-01	Warnings	Exact identifier application number: M016
NUVALU PETROLEUM COCOA BUTTER	WHITE PETROLATUM	Ningbo Liyuan Daily Chemical Products Co., Ltd.	49472319-09d1-7c4f-e063-6294a90a26a7	2026-01-01	Warnings	Exact identifier application number: M016
Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance Free	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	1fa6282a-172e-f5c8-e063-6294a90a4fb1	2025-12-31	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Latte	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	27713ae6-b428-e0d7-e063-6394a90a7a89	2025-12-31	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
69396-021-54	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