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
IngredientStrength
STANNOUS FLUORIDE1.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f9e346e-d664-81d5-e063-6394a90a4525Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-613-45Crest Pro-HealthGum Detoxify Plus1 in 1 CARTONPASTE, DENTIFRICE12
84126-613-45Crest Pro-HealthGum Detoxify Plus127 g in 1 TUBEPASTE, DENTIFRICE1272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-613CREST PRO-HEALTH GUM DETOXIFY PLUS (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 2 package rows20250308_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 43 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Total Care Zero Alcohol Anticavity Fresh MintSODIUM FLUORIDEKenvue Brands LLC4b594a6e-db1d-443b-bfa7-23ee15749f472024-12-19WarningsExact identifier
application number: M021
NewYork-Presbyterian AmenitySODIUM MONOFLUOROPHOSPATEASP Global, LLc4b307471-445d-4c51-a499-d074a8172f202024-12-17WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
application number: M021
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG03ec09f9-4281-9ccb-e063-6294a90aadd82024-12-01WarningsExact identifier
application number: M021
CURODONT PROTECTSTANNOUS FLUORIDECREDENTIS AG03ec591c-68c3-a380-e063-6394a90a131a2024-12-01WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Bubble Gum BlowoutSODIUM FLUORIDEChattem, Inc.61f3a3e6-645b-4368-b1d5-7de1fc14542e2024-12-01WarningsExact identifier
application number: M021
SparkleFresh Flouride ToothpasteSODIUM MONOFLUOROPHOSPHATEMedline Industries, LP1565528b-89f2-4c97-b294-15b6ebd3f80e2024-11-26WarningsExact identifier
application number: M021
Rembrandt Intense StainSODIUM FLUORIDERanir LLC55dcd063-5661-35aa-e054-00144ff8d46c2024-11-26WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLC9f98913f-6754-4e1c-98cf-b89fe87750f82024-11-25WarningsExact identifier
application number: M021
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company88f87f7a-5b2d-47c9-8830-6b88b4ddbb592024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC0c85d273-3b98-43ea-81ba-c90f70ab72f82024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC2a882210-49e6-4b9c-a2c6-eaa37b6514c32024-11-25WarningsExact identifier
application number: M021
Pepsodent Complete Care OriginalSODIUM FLUORIDEChurch & Dwight Co., Inc.3c6931cb-0ec9-41bb-b410-c355573aab572024-11-21WarningsExact identifier
application number: M021
Firefly Strawberry Natural FluorideSODIUM FLUORIDERanir LLC8ee37955-fe1a-4964-ac29-d1d7dfb694cc2024-11-21WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCabdc7f79-5f87-4307-8ddd-e6281ac67a042024-11-20WarningsExact identifier
application number: M021
AIM Bubble BerrySODIUM FLUORIDEChurch & Dwight Co., Inc.c83ccdea-d75f-4084-853e-ed4bab9a12d42024-11-20WarningsExact identifier
application number: M021
AIM TARTAR CONTROL Plus Mouthwash and WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fc71c-d28e-4afa-e054-00144ff8d46c2024-11-20WarningsExact identifier
application number: M021
Advance White Tartar Control Breath FresheningSODIUM FLUORIDEChurch & Dwight Co., Inc.aa8be8f5-ba46-4b1b-afaa-58fddf8f87802024-11-20WarningsExact identifier
application number: M021
Enamel DefenseSODIUM FLUORIDEChurch & Dwight Co., Inc.9e8f1ce9-b161-50db-e053-2995a90ad32b2024-11-20WarningsExact identifier
application number: M021
Rembrandt Deeply White Plus PeroxideSODIUM MONOFLUOROPHOSPHATERanir LLCbf7da007-ab9d-4631-bc28-6ca245fd62652024-11-20WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN2f9e346e-d664-81d5-e063-6394a90a45252
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD2f9e346e-d664-81d5-e063-6394a90a45252
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY2f9e346e-d664-81d5-e063-6394a90a45252
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY2f9e346e-d664-81d5-e063-6394a90a45252
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY2f9e346e-d664-81d5-e063-6394a90a45252

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-613-45841260613451 TUBE in 1 CARTON (84126-613-45) / 127 g in 1 TUBE1 tube2024-06-03NoNoCurrent