Sinus Cleanser

Product NDC: 64616-035
11-digit product format: 646160035
Labeler code: 64616
Product ID: 64616-035_d465b9e7-448f-9c72-e053-2a95a90a8c58
Type: HUMAN OTC DRUG
Nonproprietary name: Sinus Relief
Dosage form: LIQUID
Route: NASAL
Labeler: Vitality Works, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2002-05-07
Marketing end: 0000-00-00
Substance: BAPTISIA TINCTORIA ROOT
Active strength: 12 1/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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	64616-035		I	Inactivated by FDA		2026-08-03
excluded package	package	64616-035	64616-035-01	I	Inactivated by FDA		2026-08-03

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 · 30 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	64616-035-01	`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	64616-035-01	`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	64616-035-01	`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	64616-035-01	`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	64616-035-01	`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	64616-035-01	`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	64616-035-01	`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	64616-035-01	`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	64616-035-01	`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	64616-035-01	`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	64616-035-01	`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	64616-035-01	`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	64616-035-01	`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	64616-035-01	`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	64616-035-01	`1332a3947898…`	`d4bfe170f9cd…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64616-035-01	2023-01-30	C162847	48780-1	f386c64a-300a-0266-e053-dadaa90a7c1a	Sinus Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64616-035-01	Sinus Cleanser	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BAPTISIA TINCTORIA ROOT	ACTIVE INGREDIENT	5EF0HWI5WU	SINUS CLEANSER (SINUS RELIEF) LIQUID [VITALITY WORKS, INC.]	1
BAPTISIA TINCTORIA ROOT	ACTIVE MOIETY	5EF0HWI5WU	SINUS CLEANSER (SINUS RELIEF) LIQUID [VITALITY WORKS, INC.]	1
CITRUS PARADISI SEED	INACTIVE INGREDIENT	12F08874Y7	SINUS CLEANSER (SINUS RELIEF) LIQUID [VITALITY WORKS, INC.]	1
OREGANO	INACTIVE INGREDIENT	0E5AT8T16U	SINUS CLEANSER (SINUS RELIEF) LIQUID [VITALITY WORKS, INC.]	1
SILVER	INACTIVE INGREDIENT	3M4G523W1G	SINUS CLEANSER (SINUS RELIEF) LIQUID [VITALITY WORKS, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	SINUS CLEANSER (SINUS RELIEF) LIQUID [VITALITY WORKS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SINUS CLEANSER (SINUS RELIEF) LIQUID [VITALITY WORKS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64616-035	SINUS CLEANSER (SINUS RELIEF) LIQUID [VITALITY WORKS, INC.]	5	Legacy NDC, 1 package rows	20211231_8d736f01-99bf-4b74-9fa1-9ffb4d7a7090.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
5EF0HWI5WU	BAPTISIA TINCTORIA ROOT	BAPTISIA TINCTORIA ROOT

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64616-035-01	64616003501	118 mL in 1 BOTTLE, PLASTIC (64616-035-01)	118 ml	2002-05-07	0000-00-00	No	No	Current