Luster Premium White

Product NDC: 72805-120
Requested package NDC: 72805-120-13
11-digit product format: 728050120
Labeler code: 72805
Product ID: 72805-120_3e70f61f-fbdb-46ff-a507-ca0ef8ecf2d0
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride and Sodium Monofluorophosphate
Dosage form: KIT
Labeler: French Transit, Ltd.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2018-04-01
Marketing end: 0000-00-00
Active strength: 0
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	72805-120	72805-120-13	I	Inactivated by FDA		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 · 10 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-30	Luster Premium White ® AM/PM
2020-12-17	Luster Premium White ® AM/PM
2020-09-27	Luster Premium White ® AM/PM
2020-09-25	Luster Premium White ® AM/PM
2020-07-22	Luster Premium White ® AM/PM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72805-120-13	Luster Premium White AM/PM	1 in 1 CARTON	KIT	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72805-120	LUSTER PREMIUM WHITE AM/PM (SODIUM FLUORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [FRENCH TRANSIT, LTD.]	4	Legacy NDC, 1 package rows	20220113_94542fbc-fab4-4709-9741-7dcfca253ba2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
416783	sodium fluoride 0.24 % Toothpaste	PSN	94542fbc-fab4-4709-9741-7dcfca253ba2	4
1546238	sodium monofluorophosphate 0.88 % Toothpaste	PSN	94542fbc-fab4-4709-9741-7dcfca253ba2	4
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	94542fbc-fab4-4709-9741-7dcfca253ba2	4
1546238	sodium monofluorophosphate 0.0088 MG/MG Toothpaste	SCD	94542fbc-fab4-4709-9741-7dcfca253ba2	4
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	94542fbc-fab4-4709-9741-7dcfca253ba2	4
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	94542fbc-fab4-4709-9741-7dcfca253ba2	4
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	94542fbc-fab4-4709-9741-7dcfca253ba2	4
1546238	sodium monofluorophosphate 0.88 % (fluoride ion 0.115 % )Toothpaste	SY	94542fbc-fab4-4709-9741-7dcfca253ba2	4
1546238	sodium monofluorophosphate 0.88 % Toothpaste	SY	94542fbc-fab4-4709-9741-7dcfca253ba2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72805-120-13	72805012013	1 KIT in 1 CARTON (72805-120-13) * 113 g in 1 TUBE * 113 g in 1 TUBE	1 kit	2018-04-01	0000-00-00	No	No	Current