Endit zinc oxide skin protection

Product NDC: 64068-500
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 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	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
64068-500-02	64068050002	113.4 g in 1 JAR (64068-500-02)	113.4 g	2022-08-09	0000-00-00	No	No	Current
64068-500-03	64068050003	227 g in 1 JAR (64068-500-03)	227 g	2022-08-09	0000-00-00	No	No	Current