FDA.reportPublic FDA data

Crest Pro-Health

Product NDC
84126-608
11-digit product format
841260608
Labeler code
84126
Product ID
84126-608_47e53855-2e47-b2a1-e063-6294a90a8be4
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
2023-09-01
Substance
STANNOUS FLUORIDE
Active strength
1.5 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Crest Pro-Health
Brand name suffix
Maximum Cavity Protection
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FTR44B32Q
Rxcui416784

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
84126-608-03Crest Pro-HealthMaximum Cavity Protection121 g in 1 TUBEPASTE, DENTIFRICE1212
84126-608-03Crest Pro-HealthMaximum Cavity Protection3 in 1 CARTONPASTE, DENTIFRICE32
84126-608-04Crest Pro-HealthMaximum Cavity Protection121 g in 1 TUBEPASTE, DENTIFRICE1212
84126-608-04Crest Pro-HealthMaximum Cavity Protection2 in 1 CARTONPASTE, DENTIFRICE22
84126-608-26Crest Pro-HealthMaximum Cavity Protection73 g in 1 TUBEPASTE, DENTIFRICE732
84126-608-26Crest Pro-HealthMaximum Cavity Protection1 in 1 CARTONPASTE, DENTIFRICE12
84126-608-43Crest Pro-HealthMaximum Cavity Protection121 g in 1 TUBEPASTE, DENTIFRICE1212
84126-608-43Crest Pro-HealthMaximum Cavity Protection1 in 1 CARTONPASTE, DENTIFRICE12
84126-608-85Crest Pro-HealthMaximum Cavity Protection24 g in 1 TUBEPASTE, DENTIFRICE242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-608CREST PRO-HEALTH MAXIMUM CAVITY PROTECTION (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 9 package rows20250227_2eaeddc5-1559-9378-e063-6394a90a4ed7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN2eaeddc5-1559-9378-e063-6394a90a4ed72
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD2eaeddc5-1559-9378-e063-6394a90a4ed72
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY2eaeddc5-1559-9378-e063-6394a90a4ed72
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY2eaeddc5-1559-9378-e063-6394a90a4ed72
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY2eaeddc5-1559-9378-e063-6394a90a4ed72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-608-03841260608033 TUBE in 1 CARTON (84126-608-03) / 121 g in 1 TUBE3 tube2023-09-01NoNoCurrent
84126-608-04841260608042 TUBE in 1 CARTON (84126-608-04) / 121 g in 1 TUBE2 tube2023-09-01NoNoCurrent
84126-608-26841260608261 TUBE in 1 CARTON (84126-608-26) / 73 g in 1 TUBE1 tube2023-09-01NoNoCurrent
84126-608-43841260608431 TUBE in 1 CARTON (84126-608-43) / 121 g in 1 TUBE1 tube2023-09-01NoNoCurrent
84126-608-858412606088524 g in 1 TUBE (84126-608-85) 24 g2023-09-01NoNoCurrent