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 23 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 Deep Clean	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	973ce138-c64e-c059-e053-2a95a90a3148	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4c3ad36-72d8-16e8-e053-2a95a90a8702	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4d65b58-9818-820d-e053-2995a90a9f00	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Sensitive and Gum All Day Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4d775a1-a4f6-cd69-e053-2995a90a5f64	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Enamel Repair and Gum Advanced Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4ead762-17b2-22a0-e053-2a95a90ac866	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Luminous Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5c82742-fb27-62a2-e053-2a95a90aa7c4	2026-01-08	Warnings	Exact identifier application number: M021
Native Whitening	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	a5248d35-f488-3457-e053-2995a90a411e	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Charcoal	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	b7882679-339c-554f-e053-2995a90afa7f	2026-01-08	Warnings	Exact identifier application number: M021
Burts Bees Kids Strawberry Splash	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	b6c180ae-00da-6fab-e053-2a95a90a089e	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Plus Scope Outlast	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	b6f9a813-7ed6-895c-e053-2995a90a9ea6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Scope Dual Blast Active Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	b788d16a-8a58-0352-e053-2a95a90a965e	2026-01-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Scope Outlast Active Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	b789587e-7f49-163a-e053-2a95a90a823f	2026-01-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Advanced Whitening Active Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	b81a22dc-b759-24cd-e053-2995a90a9148	2026-01-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Deep Clean Active Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	b851fe5c-d904-12da-e053-2a95a90a86f9	2026-01-08	Warnings	Exact identifier application number: M021
Crest Baking Soda and Peroxide Whitening with Tartar Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	adebbd47-011d-4cd3-a002-1eb67e885e5b	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Stain Shield	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5c9b5ef-8dd4-a842-e053-2a95a90ad387	2026-01-08	Warnings	Exact identifier application number: M021
Kids Crest Bubblegum Rush	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	7baa77f5-fe45-6566-e053-2991aa0a381f	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Vibrant Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f63c3354-a264-8130-e053-2a95a90a2022	2026-01-08		Exact identifier application number: M021
Crest Pro Health Clean Mint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	fb466fb4-0915-a41f-e053-6294a90a2dfb	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Clean and Free	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	fb4771cd-f478-e2bd-e053-6394a90aa83e	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