Colgate Anticavity Kit

Product NDC
56153-001
11-digit product format
561530001
Labeler code
56153
Product ID
56153-001_457da217-6b55-47d5-e063-6394a90ab441
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Ming Fai Industrial (Shenzhen) Co. Ltd
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-09
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
7.6 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate Anticavity Kit
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE7.6 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui545626

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56153-001-05Colgate Anticavity Kit5 g in 1 TUBEPASTE, DENTIFRICE511
56153-001-05Colgate Anticavity Kit1 in 1 PACKAGEPASTE, DENTIFRICE111
56153-001-10Colgate Anticavity Kit10 g in 1 TUBEPASTE, DENTIFRICE1011
56153-001-10Colgate Anticavity Kit1 in 1 PACKAGEPASTE, DENTIFRICE111

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium MonofluorophosphateACTIVE INGREDIENTC810JCZ56QCOLGATE ANTICAVITY KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MING FAI INDUSTRIAL (SHENZHEN) CO. LTD]4
fluoride IonACTIVE MOIETYQ80VPU408OCOLGATE ANTICAVITY KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MING FAI INDUSTRIAL (SHENZHEN) CO. LTD]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPCOLGATE ANTICAVITY KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MING FAI INDUSTRIAL (SHENZHEN) CO. LTD]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311COLGATE ANTICAVITY KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MING FAI INDUSTRIAL (SHENZHEN) CO. LTD]4
LIMONENE, DL-INACTIVE INGREDIENT9MC3I34447COLGATE ANTICAVITY KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MING FAI INDUSTRIAL (SHENZHEN) CO. LTD]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE ANTICAVITY KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MING FAI INDUSTRIAL (SHENZHEN) CO. LTD]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE ANTICAVITY KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MING FAI INDUSTRIAL (SHENZHEN) CO. LTD]4
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZCOLGATE ANTICAVITY KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MING FAI INDUSTRIAL (SHENZHEN) CO. LTD]4
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE ANTICAVITY KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MING FAI INDUSTRIAL (SHENZHEN) CO. LTD]4
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE ANTICAVITY KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MING FAI INDUSTRIAL (SHENZHEN) CO. LTD]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56153-001COLGATE ANTICAVITY KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MING FAI INDUSTRIAL (SHENZHEN) CO. LTD]10Current NDC, Legacy NDC, 4 package rows20231025_121decce-c364-4060-87da-0c6a6cd48474.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN121decce-c364-4060-87da-0c6a6cd4847411
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD121decce-c364-4060-87da-0c6a6cd4847411
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY121decce-c364-4060-87da-0c6a6cd4847411
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY121decce-c364-4060-87da-0c6a6cd4847411
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY121decce-c364-4060-87da-0c6a6cd4847411
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY121decce-c364-4060-87da-0c6a6cd4847411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56153-001-05561530001051 TUBE in 1 PACKAGE (56153-001-05) / 5 g in 1 TUBE1 tube2013-05-090000-00-00NoNoCurrent
56153-001-10561530001101 TUBE in 1 PACKAGE (56153-001-10) / 10 g in 1 TUBE1 tube2013-05-090000-00-00NoNoCurrent