Idodent Flouride Mint

Product NDC: 65923-181
11-digit product format: 659230181
Labeler code: 65923
Product ID: 65923-181_d191f4ee-589e-c58b-e053-2995a90a5e2c
Type: HUMAN OTC DRUG
Nonproprietary name: Fluoride
Dosage form: PASTE
Route: DENTAL
Labeler: United Exchange Corp.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-10-23
Marketing end: 0000-00-00
Substance: SODIUM MONOFLUOROPHOSPHATE
Active strength: 1 g/100g
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	65923-181		I	Inactivated by FDA		2026-10-05
excluded package	package	65923-181	65923-181-18	D	Discontinued by firm		2026-10-05

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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65923-181-18	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65923-181-18	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65923-181-18	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65923-181-18	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65923-181-18	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65923-181-18	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65923-181-18	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65923-181-18	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65923-181-18	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65923-181-18	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65923-181-18	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65923-181-18	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65923-181-18	2023-01-30	C162847	48780-1	f386c64a-0c6f-0266-e053-dadaa90a7c1a	35170ad8-53e5-4c69-82e3-7615da2f5087

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65923-181-18	Idodent Flouride Mint	181 g in 1 TUBE	PASTE	181		5
65923-181-18	Idodent Flouride Mint	1 in 1 CARTON	PASTE	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	IDODENT FLOURIDE MINT (FLUORIDE) PASTE [UNITED EXCHANGE CORP.]	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	IDODENT FLOURIDE MINT (FLUORIDE) PASTE [UNITED EXCHANGE CORP.]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	IDODENT FLOURIDE MINT (FLUORIDE) PASTE [UNITED EXCHANGE CORP.]	2
CARBOXYMETHYLCELLULOSE	INACTIVE INGREDIENT	05JZI7B19X	IDODENT FLOURIDE MINT (FLUORIDE) PASTE [UNITED EXCHANGE CORP.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	IDODENT FLOURIDE MINT (FLUORIDE) PASTE [UNITED EXCHANGE CORP.]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	IDODENT FLOURIDE MINT (FLUORIDE) PASTE [UNITED EXCHANGE CORP.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IDODENT FLOURIDE MINT (FLUORIDE) PASTE [UNITED EXCHANGE CORP.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	IDODENT FLOURIDE MINT (FLUORIDE) PASTE [UNITED EXCHANGE CORP.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	IDODENT FLOURIDE MINT (FLUORIDE) PASTE [UNITED EXCHANGE CORP.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	IDODENT FLOURIDE MINT (FLUORIDE) PASTE [UNITED EXCHANGE CORP.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65923-181	IDODENT FLOURIDE MINT (FLUORIDE) PASTE [UNITED EXCHANGE CORP.]	5	Legacy NDC, 2 package rows	20211125_35170ad8-53e5-4c69-82e3-7615da2f5087.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C810JCZ56Q	SODIUM MONOFLUOROPHOSPHATE	10163-15-2	SODIUM MONOFLUOROPHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	35170ad8-53e5-4c69-82e3-7615da2f5087	5
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	35170ad8-53e5-4c69-82e3-7615da2f5087	5
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	35170ad8-53e5-4c69-82e3-7615da2f5087	5
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	35170ad8-53e5-4c69-82e3-7615da2f5087	5
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	35170ad8-53e5-4c69-82e3-7615da2f5087	5
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	35170ad8-53e5-4c69-82e3-7615da2f5087	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65923-181-18	65923018118	1 TUBE in 1 CARTON (65923-181-18) > 181 g in 1 TUBE	1 tube	2016-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Idodent Flouride Mint - United Exchange Corp.	United Exchange Corp.	2021-11-24	HUMAN OTC DRUG LABEL	5