FDA.reportPublic FDA data

Crest Pro-Health

Product NDC
84126-638
11-digit product format
841260638
Labeler code
84126
Product ID
84126-638_4f1d0452-e040-cda6-e063-6394a90a2aef
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
2026-01-06
Substance
STANNOUS FLUORIDE
Active strength
1.4 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
Advanced Bacteria Protection
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.4 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
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-638-05Crest Pro-HealthAdvanced Bacteria Protection2 in 1 CARTONPASTE, DENTIFRICE21
84126-638-05Crest Pro-HealthAdvanced Bacteria Protection144 g in 1 TUBEPASTE, DENTIFRICE1441
84126-638-51Crest Pro-HealthAdvanced Bacteria Protection1 in 1 CARTONPASTE, DENTIFRICE11
84126-638-51Crest Pro-HealthAdvanced Bacteria Protection144 g in 1 TUBEPASTE, DENTIFRICE1441

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN4f1ce508-fe6e-4045-e063-6294a90ab3e21
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD4f1ce508-fe6e-4045-e063-6294a90ab3e21
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY4f1ce508-fe6e-4045-e063-6294a90ab3e21
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY4f1ce508-fe6e-4045-e063-6294a90ab3e21
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY4f1ce508-fe6e-4045-e063-6294a90ab3e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-638-05841260638052 TUBE in 1 CARTON (84126-638-05) / 144 g in 1 TUBE2 tube2026-01-06NoNoHistorical
84126-638-51841260638511 TUBE in 1 CARTON (84126-638-51) / 144 g in 1 TUBE1 tube2026-01-06NoNoHistorical