FDA.reportPublic FDA data

KIDS Crest

Product NDC
84126-612
11-digit product format
841260612
Labeler code
84126
Product ID
84126-612_47e5406b-31c0-aec9-e063-6294a90ac186
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
2024-06-01
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
KIDS Crest
Brand name suffix
Advanced Sugar and Bacteria 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
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
84126-612-03KIDS CrestAdvanced Sugar and Bacteria Shield3 in 1 CELLO PACKPASTE, DENTIFRICE32
84126-612-03KIDS CrestAdvanced Sugar and Bacteria Shield1 in 1 CARTONPASTE, DENTIFRICE12
84126-612-41KIDS CrestAdvanced Sugar and Bacteria Shield1 in 1 CARTONPASTE, DENTIFRICE12
84126-612-41KIDS CrestAdvanced Sugar and Bacteria Shield116 g in 1 TUBEPASTE, DENTIFRICE1162
84126-612-85KIDS CrestAdvanced Sugar and Bacteria Shield1 in 1 CARTONPASTE, DENTIFRICE12
84126-612-85KIDS CrestAdvanced Sugar and Bacteria Shield24 g in 1 TUBEPASTE, DENTIFRICE242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-612KIDS CREST ADVANCED SUGAR AND BACTERIA SHIELD (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 6 package rows20250305_2f371af0-a2d4-25a6-e063-6394a90a923d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN2f371af0-a2d4-25a6-e063-6394a90a923d2
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD2f371af0-a2d4-25a6-e063-6394a90a923d2
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY2f371af0-a2d4-25a6-e063-6394a90a923d2
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY2f371af0-a2d4-25a6-e063-6394a90a923d2
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY2f371af0-a2d4-25a6-e063-6394a90a923d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-612-03841260612033 CARTON in 1 CELLO PACK (84126-612-03) / 1 TUBE in 1 CARTON / 116 g in 1 TUBE3 carton2024-06-01NoNoCurrent
84126-612-41841260612411 TUBE in 1 CARTON (84126-612-41) / 116 g in 1 TUBE1 tube2024-06-01NoNoCurrent
84126-612-85841260612851 TUBE in 1 CARTON (84126-612-85) / 24 g in 1 TUBE1 tube2024-06-01NoNoCurrent