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 18 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity Fluoride RinseSODIUM FLUORIDELidl US, LLCc47475aa-3125-410f-aa31-0add6e4ce1252026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Crest 3D White Brilliance Pro Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyf4c02924-95ee-09d2-e053-2995a90a81212026-02-03Exact identifier
application number: M021
Crest 3D White Stain Eraser Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5d97011-7be3-3b1c-e053-2a95a90ade862026-02-03Exact identifier
application number: M021
AnticavitySODIUM FLUORIDEDemoulas Super Markets, Inc.c28c3475-efbb-4099-83ab-ab91bac9dfc32026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEDemoulas Super Markets, Inc65abfb4d-3a1e-42df-b343-f270ce60a3bf2026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company102e4d9c-0fae-d48a-e063-6294a90aac942026-02-03WarningsExact identifier
application number: M021
Crest Plus Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company08767b0f-ed6e-8d32-e063-6294a90a10cd2026-02-03WarningsExact identifier
application number: M021
Crest Braces Care Anticavity Fluoride RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd8398cfd-9af6-690d-e053-2995a90a9b7c2026-02-03WarningsExact identifier
application number: M021
AutoBrush bubblegumSODIUM FLUORIDELander Enterprises, LLC2e85d6f7-2df8-4eb9-bc97-d7b7af7fb4602026-02-03WarningsExact identifier
application number: M021
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLCd859d02d-a036-4d90-bed4-9a5c31e9e1ef2026-02-03WarningsExact identifier
application number: M021
Glowing WhiteSODIUM FLUORIDEDemoulas Super Markets, Inc32faf47d-b64f-4454-9f14-51503504c6b52026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Sodium fluorideSODIUM FLUORIDEDemoulas Super Markets, Inc2f5d3c75-1a11-47e1-b297-e2302177efe72026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEDemoulas Super Markets, Inc096e6a1d-316b-432a-bf27-70e8a13337cc2026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC49d1932f-a85c-7b8f-e063-6394a90a6aca2026-02-02WarningsExact identifier
application number: M021
Listerine Total Care Mild Alcohol Free Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC49d4f96f-e61f-e6e6-e063-6294a90ab0a02026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Toy Story Wild West WatermelonSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d69901-0b07-b07d-e063-6394a90a3c342026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Frozen Blizzard BerrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d6c1c9-cd21-cac6-e063-6294a90a81d62026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Disney Princesses Grand GrapeSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d6f926-da4e-26df-e063-6294a90a1c0c2026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Spidey and Hist Amazing Friends Peter Parker PunchSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d70b88-d57c-37cd-e063-6294a90a4a592026-02-02WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDERite Aid Corporation54a8b884-969a-4a41-ac2a-bc1f1fe9f7fe2026-02-02Warnings, 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