FDA.reportPublic FDA data

Crest Pro-Health

Product NDC
84126-639
11-digit product format
841260639
Labeler code
84126
Product ID
84126-639_4f1d60b7-cd30-3192-e063-6294a90aa82a
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride and Potassium Nitrate
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
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.4 mg/g; 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
Sensitivity Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.4 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038800

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-639-05Crest Pro-HealthSensitivity Relief144 g in 1 TUBEPASTE, DENTIFRICE1441
84126-639-05Crest Pro-HealthSensitivity Relief2 in 1 CARTONPASTE, DENTIFRICE21
84126-639-51Crest Pro-HealthSensitivity Relief1 in 1 CARTONPASTE, DENTIFRICE11
84126-639-51Crest Pro-HealthSensitivity Relief144 g in 1 TUBEPASTE, DENTIFRICE1441

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.14 % - 0.15 % ) ToothpastePSN4f1d62ae-653e-3046-e063-6294a90abbf81
1038800potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG ToothpasteSCD4f1d62ae-653e-3046-e063-6294a90abbf81
1038800K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY4f1d62ae-653e-3046-e063-6294a90abbf81
1038800Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY4f1d62ae-653e-3046-e063-6294a90abbf81
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY4f1d62ae-653e-3046-e063-6294a90abbf81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-639-05841260639052 TUBE in 1 CARTON (84126-639-05) / 144 g in 1 TUBE2 tube2026-01-06NoNoHistorical
84126-639-51841260639511 TUBE in 1 CARTON (84126-639-51) / 144 g in 1 TUBE1 tube2026-01-06NoNoHistorical