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 21 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HISMILESODIUM FLUORIDEHISMILE PTY LTD1de591d9-9cab-e63d-e063-6394a90ac8eb2026-01-15WarningsExact identifier
application number: M021
Ice Pop Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD20e1603e-bcd1-6a5e-e063-6294a90ad1db2026-01-15WarningsExact identifier
application number: M021
HismileCANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHISMILE PTY LTD1e725b7e-accc-f51c-e063-6394a90a455c2026-01-15WarningsExact identifier
application number: M021
Enamelon Preventive TreatmentSTANNOUS FLUORIDEPremier Dental Products Company04c3f178-7905-404d-9ac2-67c453287ddf2026-01-13WarningsExact identifier
application number: M021
EnamelonSTANNOUS FLUORIDEPremier Dental Products Company1626375a-f78b-4192-b7f3-ca932acab7fb2026-01-13WarningsExact identifier
application number: M021
ARU CAVITY PROTECTIONSODIUM FLUORIDEAshtel Studios, Inc.97bd2934-4bff-4fdb-9199-fcdc0f77fada2026-01-13WarningsExact identifier
application number: M021
ACT Anticavity Fluoride CinnamonSODIUM FLUORIDEChattem, Inc.f2952ca5-c1c3-42fc-82a4-08662286be442026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids Wild WatermelonSODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION)Chattem, Inc.bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a82026-01-12WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Pineapple PunchSODIUM FLUORIDEChattem, Inc.2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b2026-01-12WarningsExact identifier
application number: M021
Botao Kids Strawberry Flavored with FluorideBOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDEPeer Pharm Ltd.48b8d884-5e15-4145-8521-ae9ee482e3922026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Fresh MintSODIUM FLUORIDEChattem, Inc.4ee6a478-afcf-4540-b427-ba08c942ccb32026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride MintSODIUM FLUORIDEChattem, Inc.e81c83a2-363a-442f-8731-2598a4f4c21e2026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.258b78b4-55e7-410c-90f8-a3e456c025792026-01-12WarningsExact identifier
application number: M021
ACT Total Care Dry Mouth Anticavity MouthSODIUM FLUORIDEChattem, Inc.06684b82-aaa0-4ca6-8d56-4f98662690002026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids Groovy GrapeSODIUM FLUORIDEChattem, Inc.cd167c0b-2086-4204-b0ac-90df404bd4bb2026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.beded786-bb55-4ba3-82fe-9e9d1b5e29792026-01-12WarningsExact identifier
application number: M021
ACT Kids Pure Protect Anticavity- Simply StrawberrySODIUM FLUORIDEChattem, Inc.2fc80727-57c7-4a33-80e0-ab9f9487390d2026-01-12WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Groovy GrapeSODIUM FLUORIDEChattem, Inc.310a3c11-1c66-4dac-99f4-5fdc15d0f77c2026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids BubblegumSODIUM FLUORIDEChattem, Inc.fbbccd58-a816-4a93-a658-f28246c11e802026-01-12WarningsExact identifier
application number: M021
ACT Whitening Anticavity Gentle MintSODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION)Chattem, Inc.cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf492026-01-12WarningsExact 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