Olive Leaf Throat

Product NDC: 64616-037
11-digit product format: 646160037
Labeler code: 64616
Product ID: 64616-037_8be28928-bf45-4427-99c9-a6e5a66d0136
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Throat Spray
Dosage form: SPRAY
Route: ORAL
Labeler: Vitality Works, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2003-02-27
Marketing end: 0000-00-00
Substance: BAPTISIA TINCTORIA
Active strength: 4 [hp_X]/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	64616-037		I	Inactivated by FDA		2026-08-17
excluded package	package	64616-037	64616-037-02	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64616-037-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64616-037-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64616-037-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64616-037-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64616-037-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64616-037-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64616-037-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64616-037-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64616-037-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64616-037-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64616-037-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64616-037-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64616-037-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64616-037-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64616-037-02	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64616-037-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64616-037-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64616-037-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64616-037-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64616-037-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	64616-037-02	`9bebd1f3094a…`	`5416666fcb17…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64616-037-02	2020-01-31	C162847	48780-1	9d75b9cf-f7e2-f424-e053-dadaa90a57ce	f0dbe0b1-b1ba-4b2c-a179-739145c39aa7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64616-037-01	Olive Leaf Throat	30 mL in 1 PACKAGE	SPRAY	30		2
64616-037-02	Olive Leaf Throat	1 in 1 CARTON	SPRAY	1		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BAPTISIA TINCTORIA	ACTIVE INGREDIENT	5K1UO2888Y	OLIVE LEAF THROAT (THROAT SPRAY) SPRAY [VITALITY WORKS, INC.]	2
BAPTISIA TINCTORIA	ACTIVE MOIETY	5K1UO2888Y	OLIVE LEAF THROAT (THROAT SPRAY) SPRAY [VITALITY WORKS, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	OLIVE LEAF THROAT (THROAT SPRAY) SPRAY [VITALITY WORKS, INC.]	2
OLEA EUROPAEA LEAF	INACTIVE INGREDIENT	MJ95C3OH47	OLIVE LEAF THROAT (THROAT SPRAY) SPRAY [VITALITY WORKS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	OLIVE LEAF THROAT (THROAT SPRAY) SPRAY [VITALITY WORKS, INC.]	2
Xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	OLIVE LEAF THROAT (THROAT SPRAY) SPRAY [VITALITY WORKS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64616-037	OLIVE LEAF THROAT (THROAT SPRAY) SPRAY [VITALITY WORKS, INC.]	2	Legacy NDC, 2 package rows	20140521_f0dbe0b1-b1ba-4b2c-a179-739145c39aa7.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
5K1UO2888Y	BAPTISIA TINCTORIA	BAPTISIA TINCTORIA

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
64616-037-01	64616003701	30 mL in 1 PACKAGE	30 ml	Historical
64616-037-02	64616003702	1 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Throat Spray - Vitality Works, Inc.	Vitality Works, Inc.	2014-05-20	HUMAN PRESCRIPTION DRUG LABEL	2