Endit zinc oxide skin protection

Product NDC: 64068-500
Requested package NDC: 64068-500-01
11-digit product format: 640680500
Labeler code: 64068
Product ID: 64068-500_47f5517a-46c6-6d06-e063-6394a90aa5c9
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: EndIt Laboratories, Inc.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-08-09
Substance: ZINC OXIDE
Active strength: 200 mg/g
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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: Endit zinc oxide skin protection
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	200 mg/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
e60bb0da-3349-f8f9-e053-2a95a90a9051	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64068-500-01	Endit zinc oxide skin protection	56.7 g in 1 JAR	OINTMENT	56.7	3
64068-500-02	Endit zinc oxide skin protection	113.4 g in 1 JAR	OINTMENT	113.4	3
64068-500-03	Endit zinc oxide skin protection	227 g in 1 JAR	OINTMENT	227	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64068-500	ENDIT ZINC OXIDE SKIN PROTECTION (ZINC OXIDE) OINTMENT [ENDIT LABORATORIES, INC.]	2	Current NDC, Legacy NDC, 3 package rows	20231215_e60bb0da-3349-f8f9-e053-2a95a90a9051.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 47 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AOAO Retinol Anti-aging Box Set	COLLAGEN,BUTYROSPERMUM PARKII (SHEA) BUTTER EXTRACT,HYALURONIC ACID,CAFFEINE,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,RETINOL.	Guangdong Junhui Biotechnology Co., LTD	24fdc31b-5291-a649-e063-6394a90a9c65	2025-01-08	Warnings	Exact identifier application number: M016
Sulfur anti-mite shower gel	SODIUM LAURETH SULFAT,DECYL GLUCOSIDE,PALM KERNELAMIDE DEA,COCAMIDOPROPYL BETAINE,LONICERA JAPONICA(HONEYSUCKLE) FLOWER EXTRACT,COLLOIDAL SULFUR.	Guangdong Junhui Biotechnology Co., Ltd	251ee057-1adf-bc97-e063-6394a90acdd3	2025-01-08	Warnings	Exact identifier application number: M016
TURMERICFaceCream	NIACINAMIDE	Shengnan (Guangzhou) Cosmetics Co., LTD	2b0652be-a216-d66b-e063-6394a90a0b28	2025-01-06	Warnings	Exact identifier application number: M016
Menthol and Zinc Oxide	MENTHOL AND ZINC OXIDE	GERI-GENTLE CORPORATION	e673d8bd-2573-9f04-e053-2995a90a172a	2025-01-06	Warnings	Exact identifier application number: M016
ClearSoothingCream	HYALURONIC ACID	Shengnan (Guangzhou) Cosmetics Co., LTD	2ac88f9a-a41b-1978-e063-6394a90a2421	2025-01-03	Warnings	Exact identifier application number: M016
MILKBODyLotion	UREA	Shengnan (Guangzhou) Cosmetics Co., LTD	2ac99028-a811-9332-e063-6294a90aee5c	2025-01-03	Warnings	Exact identifier application number: M016
Royal Jelly Scar Balm	DIMETHICONE	Distribuidora Comercial Jafra, S.A. de C.V.	27be84c1-0227-41ca-beb6-3855eff77e41	2025-01-02	Warnings	Exact identifier application number: M016
Vitamin A and D	PETROLATUM	Trifecta Pharmaceuticals USA LLC	f1ea9640-4a6d-1c76-e053-2a95a90ad3b1	2024-12-31	Warnings	Exact identifier application number: M016
Badger Diaper	ZINC OXIDE	W.S. Badger Company, Inc.	674542b2-33fb-4664-857d-4ff1d7f768a0	2024-12-31	Warnings	Exact identifier application number: M016
A and D Diaper Rash and Skin Protectant	LANOLIN AND PETROLATUM	Natureplex LLC	fcaf27c9-3634-4fb7-a311-2e093f055278	2024-12-31	Warnings	Exact identifier application number: M016
ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR	LIP PROTECTANT	REVLON CONSUMER PRODUCTS CORP	f3a6fe29-7af7-bfb1-e053-2a95a90a0101	2024-12-30	Warnings	Exact identifier application number: M016
SkinCeuticals Advanced Scar Control Skin Protectant	ALLANTOIN	L'Oreal USA Products Inc	83f4bfbb-47d8-4fe9-ba33-85142ec6221c	2024-12-28	Warnings	Exact identifier application number: M016
Personal Cleansing with Dimethicone	DIMETHICONE	Cardinal Health 200, Inc	3f9a1a90-ab12-4911-b8c2-df200b0dde5b	2024-12-27	Warnings	Exact identifier application number: M016
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT NUDE	ZINC OXIDE	Bentley Laboratories, LLC	a35ae585-f899-4c7e-8cd2-c0b2fe6a2078	2024-12-27	Warnings	Exact identifier application number: M016
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TAN	ZINC OXIDE	Bentley Laboratories, LLC	7920708a-6fa7-4bc8-94ba-096e77d9d7e1	2024-12-27	Warnings	Exact identifier application number: M016
AD Medicated Rash	AD MEDICATED RASH	WellSpring Pharmaceutical Corporation	aac345bf-ea66-4f5b-a497-c24ea72f93ea	2024-12-27	Warnings	Exact identifier application number: M016
ZO Skin Health Post Procedure Recovery System	ALUMINUM ACETATE	ZO Skin Health, Inc.	3b977415-2bf4-43a9-bb48-1eb023ca4f53	2024-12-27	Warnings	Exact identifier application number: M016
terrasil Scar Recovery	ALLANTOIN	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	2a2f91ff-a447-9d2a-e063-6394a90a84f8	2024-12-26	Warnings	Exact identifier application number: M016
WITCH HAZEL	WITCH HAZEL	CHAIN DRUG MARKETING ASSOCIATION INC	bdccee3f-0ad8-4264-a65f-ae86aed6bf03	2024-12-26	Warnings	Exact identifier application number: M016
All Over Lavender Rosemary	COLLOIDAL OAT OINTMENT	Tubby Todd	29f46671-7467-95c9-e063-6294a90a1354	2024-12-23	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	e60bb0da-3349-f8f9-e053-2a95a90a9051	3
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	e60bb0da-3349-f8f9-e053-2a95a90a9051	3
198911	zinc oxide 20 % Topical Ointment	SY	e60bb0da-3349-f8f9-e053-2a95a90a9051	3
198911	zinc oxide 200 MG per GM Topical Ointment	SY	e60bb0da-3349-f8f9-e053-2a95a90a9051	3
198911	ZNO 0.2 MG/MG Topical Ointment	SY	e60bb0da-3349-f8f9-e053-2a95a90a9051	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64068-500-01	64068050001	56.7 g in 1 JAR (64068-500-01)	56.7 g	2022-08-09	0000-00-00	No	No	Current