NDC 64616-070-01 - Cut and Wound Remedy

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 64616-070
Requested NDC: 64616-070-01
Package NDCs from labels: 64616-070-01, 64616-070-02
Manufacturer: Vitality Works, Inc.
Effective date: 2017-12-06
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Olive Leaf Cut & Wound Remedy Spray	Vitality Works, Inc.	2017-12-06	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64616-070-02	2021-01-29	C162847	48780-1	ba0f9c33-2cca-a910-e053-dadaa90a0b85	Olive Leaf Cut & Wound Remedy Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64616-070-01	Cut and Wound Remedy	30 mL in 1 BOTTLE, PLASTIC	SPRAY	30		4
64616-070-02	Cut and Wound Remedy	1 in 1 CARTON	SPRAY	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64616-070	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	4	Legacy NDC, 2 package rows	20171207_f8e5f899-1cbb-45a3-8d72-76603dbdc4a8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE INGREDIENT	18E7415PXQ	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	ACTIVE INGREDIENT	T7S323PKJS	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
HYPERICUM PERFORATUM	ACTIVE INGREDIENT	XK4IUX8MNB	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
LEDUM PALUSTRE TWIG	ACTIVE INGREDIENT	877L01IZ0P	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE MOIETY	18E7415PXQ	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	ACTIVE MOIETY	T7S323PKJS	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
HYPERICUM PERFORATUM	ACTIVE MOIETY	XK4IUX8MNB	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
LEDUM PALUSTRE TWIG	ACTIVE MOIETY	877L01IZ0P	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
CITRUS PARADISI SEED	INACTIVE INGREDIENT	12F08874Y7	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
OLEA EUROPAEA LEAF	INACTIVE INGREDIENT	MJ95C3OH47	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	CUT AND WOUND REMEDY (TOPICAL CUT AND WOUND RELIEF) SPRAY [VITALITY WORKS, INC.]	3

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 94 of 94 · 1,869 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pre Post Surgery	HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, ARNICA MONTANA	BioActive Nutritional, Inc.	2b20250f-4ca5-49a9-857f-7bef4ec86778	2016-11-10	Warnings	Exact identifier unii: XK4IUX8MNB unii: O80TY208ZW
Teething	ARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEA	BioActive Nutritional, Inc.	f39c9feb-f567-43a2-a026-2a581aeeed9d	2016-07-27	Warnings	Exact identifier unii: O80TY208ZW
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
First Degree	CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, CANTHARIS VESICATORIA	Welmedix LLC	e10bcfb8-079f-4033-a805-35d03c7ebd64	2015-08-12	Warnings	Exact identifier unii: 18E7415PXQ
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	2a96096d-43cc-49b7-af53-b53c17f41001	2014-07-25	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	b3b4b176-41f0-4ca8-90d4-3fba5707564a	2014-02-21		Exact identifier unii: 451W47IQ8X
TIS-U-SOL	SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE	Baxter Healthcare Corporation	9da4121f-d62d-4da4-8dfb-0494da16015f	2014-02-21		Exact identifier unii: 451W47IQ8X
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13		Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.