Crest Pro-Health

Product NDC: 84126-613
11-digit product format: 841260613
Labeler code: 84126
Product ID: 84126-613_47e54275-5f0d-b73b-e063-6294a90a7a8c
Type: HUMAN OTC DRUG
Nonproprietary name: Stannous fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: The Procter & Gamble Manufacturing Company
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-06-03
Substance: STANNOUS FLUORIDE
Active strength: 1.5 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Crest Pro-Health
Brand name suffix: Gum Detoxify Plus
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
STANNOUS FLUORIDE	1.5 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
2f9e346e-d664-81d5-e063-6394a90a4525	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84126-613-45	Crest Pro-HealthGum Detoxify Plus	1 in 1 CARTON	PASTE, DENTIFRICE	1		2
84126-613-45	Crest Pro-HealthGum Detoxify Plus	127 g in 1 TUBE	PASTE, DENTIFRICE	127		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84126-613	CREST PRO-HEALTH GUM DETOXIFY PLUS (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1	Current NDC, 2 package rows	20250308_2f9e346e-d664-81d5-e063-6394a90a4525.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 20 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Cavity Protection Great Regular Flavor	ANTICAVITY FLUORIDE TOOTHPASTE	Colgate-Palmolive Company	202c6c62-e16a-4716-babe-d5414006c79e	2026-01-21	Warnings	Exact identifier application number: M021
Crest 3D White Luxe Diamond Strong	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c1420129-5460-4900-ac9a-356d2d7c60a2	2026-01-21	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Max Cavity and Erosion Prevention	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	48eb0bdc-7399-745d-e063-6294a90a9809	2026-01-21	Warnings	Exact identifier application number: M021
Colgate Total Gum Protect Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	dcf81dcb-b26b-4411-82d4-5f7e9d3fc0f3	2026-01-20	Warnings	Exact identifier application number: M021
GuruNanda Anti-Cavity	SODIUM FLUORIDE	GURUNANDA, LLC	3b07b72f-4efc-eb0f-e063-6294a90a70a8	2026-01-19	Warnings	Exact identifier application number: M021
GuruNanda Anticavity	SODIUM FLUORIDE	GURUNANDA, LLC	3e90d516-3172-3c8d-e063-6294a90a394f	2026-01-19	Warnings	Exact identifier application number: M021
Hismile	PEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0eba92d1-cbdc-9c96-e063-6294a90a9afc	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	COCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef3cfb6-6bae-1682-e063-6394a90aca88	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	MANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef3f4f8-fdc4-2056-e063-6394a90a6fd7	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	SMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef41051-dfa0-b105-e063-6294a90a551f	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	WATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef43107-58ec-d4ee-e063-6294a90ad8d7	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	RED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef56539-dc21-c6ea-e063-6394a90a5790	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef6f8b5-8565-b364-e063-6294a90aabbc	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	STRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef766ae-754a-f185-e063-6294a90a3299	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	BANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef7be5b-df8f-9f32-e063-6394a90a4724	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	VANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef8d0ef-a051-f610-e063-6394a90a8537	2026-01-15	Warnings	Exact identifier application number: M021
HISMILE	SODIUM FLUORIDE	HISMILE PTY LTD	1d40b98b-2e9a-d84a-e063-6294a90a2096	2026-01-15	Warnings	Exact identifier application number: M021
HISMILE	SODIUM FLUORIDE	HISMILE PTY LTD	1d44863e-93be-2b80-e063-6294a90a4a9d	2026-01-15	Warnings	Exact identifier application number: M021
HISMILE	SODIUM FLUORIDE	HISMILE PTY LTD	1d458ccc-8f1e-f9c8-e063-6294a90a8da4	2026-01-15	Warnings	Exact identifier application number: M021
HISMILE	SODIUM FLUORIDE	HISMILE PTY LTD	1d447939-fbf6-42f6-e063-6294a90af6d9	2026-01-15	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	2f9e346e-d664-81d5-e063-6394a90a4525	2
416784	stannous fluoride 0.00454 MG/MG Toothpaste	SCD	2f9e346e-d664-81d5-e063-6394a90a4525	2
416784	stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste	SY	2f9e346e-d664-81d5-e063-6394a90a4525	2
416784	stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste	SY	2f9e346e-d664-81d5-e063-6394a90a4525	2
416784	stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste	SY	2f9e346e-d664-81d5-e063-6394a90a4525	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84126-613-45	84126061345	1 TUBE in 1 CARTON (84126-613-45) / 127 g in 1 TUBE	1 tube	2024-06-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Crest Pro-Health Gum Detoxify Plus	The Procter & Gamble Manufacturing Company	2026-01-08	HUMAN OTC DRUG LABEL	2