Rexall Restore and Defend Sensitive Whitening

Product NDC: 55910-820
11-digit product format: 559100820
Labeler code: 55910
Product ID: 55910-820_513e53d3-ae6a-4030-8052-e7b7b6ba32b3
Type: HUMAN OTC DRUG
Nonproprietary name: Stannous Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Old East Main CO.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-03-21
Substance: STANNOUS FLUORIDE
Active strength: 4.54 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
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	55910-820-01	`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	55910-820-01	`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	55910-820-01	`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	55910-820-01	`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	55910-820-01	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Rexall Restore and Defend Sensitive Whitening
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
STANNOUS FLUORIDE	4.54 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3FTR44B32Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
416784	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
691c9638-75d2-4e53-bec4-2eafacd7216c	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55910-820-01	2024-10-15	C162847	48780-1	1030e365-51cb-111a-e063-dadaa90a10e2	Rexall ™ SENSITIVE TOOTHPASTE WITH FLUORIDE - WHITENING
55910-820-01	2024-01-30	C162847	48780-1	1030e365-51cb-111a-e063-dadaa90a10e2	Rexall ™ SENSITIVE TOOTHPASTE WITH FLUORIDE - WHITENING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55910-820-01	Rexall Restore and Defend Sensitive Whitening	96.4 g in 1 TUBE	PASTE, DENTIFRICE	96.4		2
55910-820-01	Rexall Restore and Defend Sensitive Whitening	1 in 1 BOX	PASTE, DENTIFRICE	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-820	REXALL RESTORE AND DEFEND SENSITIVE WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [OLD EAST MAIN CO.]	2	Current NDC, Legacy NDC, 2 package rows	20241017_691c9638-75d2-4e53-bec4-2eafacd7216c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 26 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Complete plus Whitening plus Scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c5d5bc17-e81b-34aa-e053-2a95a90ad77f	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Gum Restore Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c5745cc4-213d-1dde-e053-2995a90af562	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Stain Shield	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	960fef18-4533-5250-e053-2995a90aaf76	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Gum Restore Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c574b51d-07bd-b363-e053-2995a90a7c0e	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Blast	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	6d9a1754-8d38-054f-e053-2991aa0a4653	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Breath Purify and Gum Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c60fdacf-d997-19a5-e053-2a95a90a96a3	2026-01-08	Warnings	Exact identifier application number: M021
Crest Cavity Protection Cool Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	3d7fffb9-47e0-73cd-e054-00144ff88e88	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Gum Detoxify Ultra	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c73ed36a-0e2f-a137-e053-2a95a90a43e0	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Extra Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c688d37e-9e80-4599-e053-2a95a90a1916	2026-01-08	Warnings	Exact identifier application number: M021
Crest Gum Detoxify plus Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	63779942-0f6c-11c5-e053-2991aa0a25ab	2026-01-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Sensitivity Active Foam	SODIUM FLUORIDE AND POTASSIUM NITRATE	The Procter & Gamble Manufacturing Company	b8535d1c-cf15-f353-e053-2a95a90a7974	2026-01-08	Warnings	Exact identifier application number: M021
Burts Bees Extra White Zen Peppermint	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	81279e1f-6224-8114-e053-2991aa0aab08	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Bacteria Shield and Gum Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c74229c4-b095-df32-e053-2a95a90a4aec	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Advanced Whitening Fresh Mint	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	c8350ab3-9347-58c0-e053-2995a90a7238	2026-01-08		Exact identifier application number: M021
Crest Premium Plus Anti-Bacterial	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	b7af946e-1cac-b8c0-e053-2a95a90afa4a	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser Polishing Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	ddcb0871-9900-125f-e053-2a95a90a75de	2026-01-08		Exact identifier application number: M021
Burts Bees Deep Clean plus Whitening	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	c924b8dd-8d84-1329-e053-2995a90a4531	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Baking Soda and Peroxide Whitening with Tartar Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	07ed767e-225c-e9c5-e063-6394a90af931	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Cavity Protection Cool Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	0813171e-bda5-b004-e063-6394a90ad364	2026-01-08	Warnings	Exact identifier application number: M021
Burts Bees Kids Strawberry Splash	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	087b3434-2636-74ce-e063-6394a90a25ad	2026-01-08	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3FTR44B32Q	STANNOUS FLUORIDE	7783-47-3	STANNOUS FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
416784	stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste	PSN	691c9638-75d2-4e53-bec4-2eafacd7216c	2
416784	stannous fluoride 0.00454 MG/MG Toothpaste	SCD	691c9638-75d2-4e53-bec4-2eafacd7216c	2
416784	stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste	SY	691c9638-75d2-4e53-bec4-2eafacd7216c	2
416784	stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste	SY	691c9638-75d2-4e53-bec4-2eafacd7216c	2
416784	stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste	SY	691c9638-75d2-4e53-bec4-2eafacd7216c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-820-01	55910082001	1 TUBE in 1 BOX (55910-820-01) / 96.4 g in 1 TUBE	1 tube	2022-03-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rexall ™ SENSITIVE TOOTHPASTE WITH FLUORIDE - WHITENING	Old East Main CO. \| Ashtel Studios Inc.	2024-10-14	HUMAN OTC DRUG LABEL	2