FDA.reportPublic FDA data

Crest

Product NDC
69423-868
11-digit product format
694230868
Labeler code
69423
Product ID
69423-868_47e49826-a288-39ed-e063-6394a90a41d7
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
2022-02-07
Substance
STANNOUS FLUORIDE
Active strength
1.6 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 Advanced Sensitive Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.6 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
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-868-03CrestPro Health Advanced Sensitive Relief136 g in 1 TUBEPASTE, DENTIFRICE1368
69423-868-03CrestPro Health Advanced Sensitive Relief3 in 1 CARTONPASTE, DENTIFRICE38
69423-868-10CrestPro Health Advanced Sensitive Relief1 in 1 CARTONPASTE, DENTIFRICE18
69423-868-10CrestPro Health Advanced Sensitive Relief2 in 1 CELLO PACKPASTE, DENTIFRICE28
69423-868-51CrestPro Health Advanced Sensitive Relief1 in 1 CARTONPASTE, DENTIFRICE18
69423-868-51CrestPro Health Advanced Sensitive Relief144 g in 1 TUBEPASTE, DENTIFRICE1448

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-868CREST PRO HEALTH ADVANCED SENSITIVE RELIEF (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, Legacy NDC, 6 package rows20250110_d7730674-7513-52cf-e053-2995a90ab32c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNd7730674-7513-52cf-e053-2995a90ab32c8
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDd7730674-7513-52cf-e053-2995a90ab32c8
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYd7730674-7513-52cf-e053-2995a90ab32c8
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYd7730674-7513-52cf-e053-2995a90ab32c8
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYd7730674-7513-52cf-e053-2995a90ab32c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-868-03694230868033 TUBE in 1 CARTON (69423-868-03) / 136 g in 1 TUBE3 tube2025-10-01NoNoHistorical
69423-868-10694230868102 CARTON in 1 CELLO PACK (69423-868-10) > 1 TUBE in 1 CARTON > 144 g in 1 TUBE2 carton2022-05-010000-00-00NoNoCurrent
69423-868-51694230868511 TUBE in 1 CARTON (69423-868-51) / 144 g in 1 TUBE1 tube2022-02-070000-00-00NoNoCurrent