Hoo gargle (Rooibos Tea Flavor)(Mouthwash)

Product NDC: 81840-1003
11-digit product format: 818401003
Labeler code: 81840
Product ID: 81840-1003_e22c386c-0c5d-542e-e053-2a95a90a7814
Type: HUMAN OTC DRUG
Nonproprietary name: xylitol
Dosage form: LIQUID
Route: DENTAL
Labeler: MIKO CO LTD
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2022-06-24
Marketing end: 0000-00-00
Substance: XYLITOL
Active strength: 1 g/100mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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	81840-1003		I	Inactivated by FDA		2026-08-10
excluded package	package	81840-1003	81840-1003-4	I	Inactivated by FDA		2026-08-10

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 · 22 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	81840-1003-4	`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	81840-1003-4	`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	81840-1003-4	`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	81840-1003-4	`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	81840-1003-4	`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	81840-1003-4	`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	81840-1003-4	`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	81840-1003-4	`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	81840-1003-4	`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	81840-1003-4	`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	81840-1003-4	`367a005e9d99…`	`383a685ebd0f…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81840-1003-4	2024-07-30	C162847	48780-1	1030e365-4a9e-111a-e063-dadaa90a10e2	Drug Facts
81840-1003-4	2024-01-30	C162847	48780-1	1030e365-4a9e-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81840-1003-1	Hoo gargle (Rooibos Tea Flavor)(Mouthwash)	12 mL in 1 CUP	LIQUID	12	1
81840-1003-2	Hoo gargle (Rooibos Tea Flavor)(Mouthwash)	30 in 1 PACKAGE	LIQUID	30	1
81840-1003-3	Hoo gargle (Rooibos Tea Flavor)(Mouthwash)	64 in 1 PACKAGE	LIQUID	64	1
81840-1003-4	Hoo gargle (Rooibos Tea Flavor)(Mouthwash)	8 in 1 PACKAGE	LIQUID	8	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81840-1003	HOO GARGLE (ROOIBOS TEA FLAVOR)(MOUTHWASH) (XYLITOL) LIQUID [MIKO CO LTD]	1	Legacy NDC, 4 package rows	20220626_e22c3849-0969-55a8-e053-2a95a90afb1a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VCQ006KQ1E	XYLITOL	87-99-0	XYLITOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81840-1003-1	81840100301	12 mL in 1 CUP	12 ml					Historical
81840-1003-2	81840100302	30 in 1 PACKAGE						Historical
81840-1003-3	81840100303	64 in 1 PACKAGE						Historical
81840-1003-4	81840100304	8 PACKAGE in 1 PACKAGE (81840-1003-4) > 64 PACKAGE in 1 PACKAGE (81840-1003-3) > 30 CUP in 1 PACKAGE (81840-1003-2) > 12 mL in 1 CUP (81840-1003-1)	8 package	2022-06-24	0000-00-00	No	No	Current