FDA.reportPublic FDA data

Colgate Anticavity Kit

Product NDC
56153-002
11-digit product format
561530002
Labeler code
56153
Product ID
56153-002_453620c9-8a69-f786-e063-6394a90a9f73
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
86dfd09d-f3b6-4c4b-852d-7e04dc5c8fecAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56153-002-05Colgate Anticavity Kit1 in 1 PACKAGEPASTE, DENTIFRICE111
56153-002-05Colgate Anticavity Kit5 g in 1 TUBEPASTE, DENTIFRICE511
56153-002-10Colgate Anticavity Kit1 in 1 PACKAGEPASTE, DENTIFRICE111
56153-002-10Colgate Anticavity Kit10 g in 1 TUBEPASTE, DENTIFRICE1011

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
56153-002COLGATE ANTICAVITY KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MING FAI INDUSTRIAL (SHENZHEN) CO. LTD]10Current NDC, Legacy NDC, 4 package rows20231025_86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 17 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Complete plus Whitening plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company960e0e3e-10e8-7426-e053-2a95a90a5b022026-02-12WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e2026-02-12WarningsExact identifier
application number: M021
Kids Crest Cavity Protection Sparkle FunSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company126c6f39-0ef7-40ee-b3ba-e56a76739c572026-02-12WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.b2f7490c-e2af-49df-b054-70fb4815f7292026-02-11Warnings, Adverse reactionsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb7d7c41e-f8b6-4e55-8acd-78eb6dda47c52026-02-09WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED48ef2635-7157-4cd7-9f99-967f0143f7f12026-02-09WarningsExact identifier
application number: M021
Made by Dentists For Kids Eyeball Juice (Watermelon)SODIUM FLUORIDEMADE BY DENTISTS INC287887df-64de-4b5d-80e2-146c77c0fa8b2026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES White Care AO ProSODIUM FLUORIDEPERIOSCIENCES LLC092bdfa3-6267-439e-9320-e51b4805d1a12026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES HYDRATING AO ProSODIUM MONOFLUOROPHOSPHATEPERIOSCIENCES LLC5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d32026-02-09WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDERetail Business Services, LLC77c066cf-f064-45d3-9732-4433165ba9ef2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDERetail Business Services, LLCd1c878a9-2151-4986-be09-cbab658cdd312026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDERetail Business Services, LLC542e067a-c134-44c9-b962-f2a2b667b76f2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Colgate 5g Toothbrush KitSODIUM MONOFLUOROPHOSPHATEWuhan Jinshengyuan Textiles Manufacturing Co., Ltd.4f0fda5e-ef42-42c3-8270-3ba614650ad12026-02-06WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDERetail Business Services, LLC3954edfd-f7f1-4218-9ee2-23f5b3661b4e2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
TheraBreath Kids Anticavity Oral Rinse BubblegumANTICAVITY ORAL RINSEChurch & Dwight Co., Inc.2770424d-7416-66d4-e063-6394a90ad4b12026-02-06WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity Whitening Plus ScopeSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company463b7820-a5ce-f8b5-e063-6394a90aa0182026-02-05WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEPublix Super Markets, Inc.14494238-872b-49e2-8bf7-df3844a0a6c82026-02-05Warnings, Adverse reactionsExact identifier
application number: M021
HAPEE EXPLOSIVE MENTHOL RED 150SODIUM MONOFLUOROPHOSPHATELAMOIYAN CORPORATION14c14694-6149-40a8-aff2-660d39f7e0c12026-02-05WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEHARRIS TEETERf759e9e4-6de2-4b80-903b-e67c06e362952026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEHARRIS TEETER571f7628-fd59-462f-96dd-67aeaa98cff12026-02-04Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec11
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec11
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec11
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec11
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec11
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56153-002-05561530002051 TUBE in 1 PACKAGE (56153-002-05) / 5 g in 1 TUBE1 tube2013-05-090000-00-00NoNoCurrent
56153-002-10561530002101 TUBE in 1 PACKAGE (56153-002-10) / 10 g in 1 TUBE1 tube2013-05-090000-00-00NoNoCurrent