FDA.reportPublic FDA data

Crest

Product NDC
69423-783
11-digit product format
694230783
Labeler code
69423
Product ID
69423-783_47e38bc0-81d7-255e-e063-6294a90a22de
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
2022-10-03
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
Brand name suffix
Pro Health Sensitive and Enamel Shield
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
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-783-21CrestPro Health Sensitive and Enamel Shield1 in 1 CARTONPASTE, DENTIFRICE17
69423-783-21CrestPro Health Sensitive and Enamel Shield59 g in 1 TUBEPASTE, DENTIFRICE597
69423-783-26CrestPro Health Sensitive and Enamel Shield73 g in 1 TUBEPASTE, DENTIFRICE737
69423-783-26CrestPro Health Sensitive and Enamel Shield1 in 1 CARTONPASTE, DENTIFRICE17
69423-783-43CrestPro Health Sensitive and Enamel Shield121 g in 1 TUBEPASTE, DENTIFRICE1217
69423-783-43CrestPro Health Sensitive and Enamel Shield1 in 1 CARTONPASTE, DENTIFRICE17
69423-783-46CrestPro Health Sensitive and Enamel Shield1 in 1 CARTONPASTE, DENTIFRICE17
69423-783-46CrestPro Health Sensitive and Enamel Shield130 g in 1 TUBEPASTE, DENTIFRICE1307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-783CREST PRO HEALTH SENSITIVE AND ENAMEL SHIELD (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, 8 package rows20250115_fb48b15c-f821-e5cd-e053-6294a90ac64c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNfb48b15c-f821-e5cd-e053-6294a90ac64c7
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDfb48b15c-f821-e5cd-e053-6294a90ac64c7
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYfb48b15c-f821-e5cd-e053-6294a90ac64c7
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYfb48b15c-f821-e5cd-e053-6294a90ac64c7
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYfb48b15c-f821-e5cd-e053-6294a90ac64c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-783-21694230783211 TUBE in 1 CARTON (69423-783-21) / 59 g in 1 TUBE1 tube2025-07-01NoNoCurrent
69423-783-26694230783261 TUBE in 1 CARTON (69423-783-26) / 73 g in 1 TUBE1 tube2022-10-03NoNoCurrent
69423-783-43694230783431 TUBE in 1 CARTON (69423-783-43) / 121 g in 1 TUBE1 tube2022-10-03NoNoCurrent
69423-783-46694230783461 TUBE in 1 CARTON (69423-783-46) / 130 g in 1 TUBE1 tube2022-10-03NoNoCurrent