FDA.reportPublic FDA data

Kids Crest Cavity Protection

Product NDC
37000-049
11-digit product format
370000049
Labeler code
37000
Product ID
37000-049_4aa743c2-8cb0-57e3-e063-6294a90a7eac
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-09-05
Substance
SODIUM 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 Cavity Protection
Brand name suffix
Sparkle Fun
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui891775

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-049-012021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-012021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-012021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-012021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-012021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-022021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-022021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-022021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-022021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-022021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-032021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-032021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-032021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-032021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-032021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-042021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-042021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-042021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-042021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-042021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-052021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-052021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-052021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-052021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-052021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-062021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-062021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-062021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-062021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-062021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-222021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-222021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-222021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-222021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-222021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-422021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-422021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-422021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-422021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-422021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-922021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-922021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-922021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-922021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-922021-02-12C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-012021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-012021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-012021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-012021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-012021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-022021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-022021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-022021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-022021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-022021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-032021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-032021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-032021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-032021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-032021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-042021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-042021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-042021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-042021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-042021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-052021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-052021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-052021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-052021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-052021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-062021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-062021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-062021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-062021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-062021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-222021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-222021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-222021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-222021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-222021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-422021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-422021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-422021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-422021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-422021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-922021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-922021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-922021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-922021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection
37000-049-922021-01-29C16284748780-1ba0f9c33-1362-a910-e053-dadaa90a0b85Kid's Crest Cavity Protection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-049-01Kids Crest Cavity ProtectionSparkle Fun24 g in 1 TUBEPASTE, DENTIFRICE2420
37000-049-01Kids Crest Cavity ProtectionSparkle Fun1 in 1 CARTONPASTE, DENTIFRICE120
37000-049-02Kids Crest Cavity ProtectionSparkle Fun1 in 1 CARTONPASTE, DENTIFRICE120
37000-049-02Kids Crest Cavity ProtectionSparkle Fun130 g in 1 TUBEPASTE, DENTIFRICE13020
37000-049-03Kids Crest Cavity ProtectionSparkle Fun2.5 g in 1 POUCHPASTE, DENTIFRICE2.520
37000-049-04Kids Crest Cavity ProtectionSparkle Fun77 g in 1 TUBEPASTE, DENTIFRICE7720
37000-049-04Kids Crest Cavity ProtectionSparkle Fun1 in 1 CARTONPASTE, DENTIFRICE120
37000-049-05Kids Crest Cavity ProtectionSparkle Fun1 in 1 CARTONPASTE, DENTIFRICE120
37000-049-05Kids Crest Cavity ProtectionSparkle Fun76 g in 1 TUBEPASTE, DENTIFRICE7620
37000-049-06Kids Crest Cavity ProtectionSparkle Fun170 g in 1 BOTTLEPASTE, DENTIFRICE17020
37000-049-22Kids Crest Cavity ProtectionSparkle Fun62 g in 1 TUBEPASTE, DENTIFRICE6220
37000-049-22Kids Crest Cavity ProtectionSparkle Fun1 in 1 CARTONPASTE, DENTIFRICE120
37000-049-30Kids Crest Cavity ProtectionSparkle Fun1 in 1 CARTONPASTE, DENTIFRICE120
37000-049-30Kids Crest Cavity ProtectionSparkle Fun3 in 1 CELLO PACKPASTE, DENTIFRICE320
37000-049-40Kids Crest Cavity ProtectionSparkle Fun119 g in 1 TUBEPASTE, DENTIFRICE11920
37000-049-40Kids Crest Cavity ProtectionSparkle Fun1 in 1 CARTONPASTE, DENTIFRICE120
37000-049-42Kids Crest Cavity ProtectionSparkle Fun119 g in 1 BOTTLE, PUMPPASTE, DENTIFRICE11920
37000-049-92Kids Crest Cavity ProtectionSparkle Fun1 in 1 CARTONPASTE, DENTIFRICE120
37000-049-92Kids Crest Cavity ProtectionSparkle Fun2 in 1 CELLO PACKPASTE, DENTIFRICE220

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7KIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
Fluoride IonACTIVE MOIETYQ80VPU408OKIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311KIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDKIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
hydrated silicaINACTIVE INGREDIENTY6O7T4G8P9KIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
micaINACTIVE INGREDIENTV8A1AW0880KIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
saccharin sodium dihydrateINACTIVE INGREDIENTSB8ZUX40TYKIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JKIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
sodium phosphateINACTIVE INGREDIENTSE337SVY37KIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
sorbitolINACTIVE INGREDIENT506T60A25RKIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPKIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]1
waterINACTIVE INGREDIENT059QF0KO0RKIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-049KIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]16Current NDC, Legacy NDC, 19 package rows20250321_126c6f39-0ef7-40ee-b3ba-e56a76739c57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN126c6f39-0ef7-40ee-b3ba-e56a76739c5720
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD126c6f39-0ef7-40ee-b3ba-e56a76739c5720
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY126c6f39-0ef7-40ee-b3ba-e56a76739c5720
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY126c6f39-0ef7-40ee-b3ba-e56a76739c5720
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY126c6f39-0ef7-40ee-b3ba-e56a76739c5720
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY126c6f39-0ef7-40ee-b3ba-e56a76739c5720

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-049-01370000049011 TUBE in 1 CARTON (37000-049-01) / 24 g in 1 TUBE1 tube2002-09-050000-00-00NoNoCurrent
37000-049-02370000049021 TUBE in 1 CARTON (37000-049-02) / 130 g in 1 TUBE1 tube2002-09-050000-00-00NoNoCurrent
37000-049-03370000049032.5 g in 1 POUCH (37000-049-03) 2.5 g2002-09-050000-00-00NoNoCurrent
37000-049-043700000490477 g in 1 TUBE77 gHistorical
37000-049-05370000049051 in 1 CARTONHistorical
37000-049-0637000004906170 g in 1 BOTTLE170 gHistorical
37000-049-22370000049221 TUBE in 1 CARTON (37000-049-22) / 62 g in 1 TUBE1 tube2019-01-070000-00-00NoNoCurrent
37000-049-30370000049303 CARTON in 1 CELLO PACK (37000-049-30) / 1 TUBE in 1 CARTON / 130 g in 1 TUBE3 carton2021-01-010000-00-00NoNoCurrent
37000-049-40370000049401 TUBE in 1 CARTON (37000-049-40) > 119 g in 1 TUBE1 tube2022-03-010000-00-00NoNoCurrent
37000-049-4237000004942119 g in 1 BOTTLE, PUMP (37000-049-42) 119 g2017-08-010000-00-00NoNoCurrent
37000-049-92370000049922 CARTON in 1 CELLO PACK (37000-049-92) > 1 TUBE in 1 CARTON > 130 g in 1 TUBE2 carton2002-09-050000-00-00NoNoCurrent