Toms Luminous White Fluoride Clean Mint

Product NDC: 51009-218
Requested package NDC: 51009-218-21
11-digit product format: 510090218
Labeler code: 51009
Product ID: 51009-218_7e71b02d-19bd-422f-b380-705a607b9823
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Tom's of Maine, Inc.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-12-01
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 0 g/g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51009-218	51009-218-21	D	Discontinued by firm		2026-10-12

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51009-218-21	Toms Luminous White Fluoride Clean Mintcavity protection / whitening	21 g in 1 TUBE	PASTE, DENTIFRICE	21	9
51009-218-40	Toms Luminous White Fluoride Clean Mintcavity protection / whitening	1 in 1 CARTON	PASTE, DENTIFRICE	1	9
51009-218-40	Toms Luminous White Fluoride Clean Mintcavity protection / whitening	113 g in 1 TUBE	PASTE, DENTIFRICE	113	9
51009-218-75	Toms Luminous White Fluoride Clean Mintcavity protection / whitening	21 g in 1 TUBE	PASTE, DENTIFRICE	21	9
51009-218-75	Toms Luminous White Fluoride Clean Mintcavity protection / whitening	1 in 1 CARTON	PASTE, DENTIFRICE	1	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51009-218	TOMS LUMINOUS WHITE FLUORIDE CLEAN MINT CAVITY PROTECTION / WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	8	Legacy NDC, 5 package rows	20241024_7d0bc7be-da6e-4c24-9be9-8a0b40f27960.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
891775	sodium fluoride 0.243 % Toothpaste	PSN	7d0bc7be-da6e-4c24-9be9-8a0b40f27960	9
891775	sodium fluoride 0.00243 MG/MG Toothpaste	SCD	7d0bc7be-da6e-4c24-9be9-8a0b40f27960	9
891775	sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste	SY	7d0bc7be-da6e-4c24-9be9-8a0b40f27960	9
891775	sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste	SY	7d0bc7be-da6e-4c24-9be9-8a0b40f27960	9
891775	sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	7d0bc7be-da6e-4c24-9be9-8a0b40f27960	9
891775	sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste	SY	7d0bc7be-da6e-4c24-9be9-8a0b40f27960	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51009-218-21	51009021821	21 g in 1 TUBE (51009-218-21)	21 g	2018-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tom's Luminous White Fluoride Clean Mint cavity protection / whitening	Tom's of Maine, Inc.	2025-11-13	HUMAN OTC DRUG LABEL	9