FDA.reportPublic FDA data

Colgate

Product NDC
65954-068
11-digit product format
659540068
Labeler code
65954
Product ID
65954-068_9ff20919-1f1d-41b7-8786-1c06d1dd675f
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Mission Hills S.A de C.V
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-01
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 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
Brand name suffix
Sparkling White Mint Zing
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui545626

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65954-068-46ColgateSparkling White Mint Zing130 g in 1 TUBEGEL, DENTIFRICE1308
65954-068-46ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE18
65954-068-48ColgateSparkling White Mint Zing226 g in 1 TUBEGEL, DENTIFRICE2268
65954-068-48ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE18
65954-068-58ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE18
65954-068-58ColgateSparkling White Mint Zing70 g in 1 TUBEGEL, DENTIFRICE708
65954-068-60ColgateSparkling White Mint Zing170 g in 1 TUBEGEL, DENTIFRICE1708
65954-068-60ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE18
65954-068-64ColgateSparkling White Mint Zing181 g in 1 TUBEGEL, DENTIFRICE1818
65954-068-64ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE18
65954-068-69ColgateSparkling White Mint Zing113 g in 1 TUBEGEL, DENTIFRICE1138
65954-068-69ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE18
65954-068-79ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE18
65954-068-79ColgateSparkling White Mint Zing79 g in 1 TUBEGEL, DENTIFRICE798
65954-068-82ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE18
65954-068-82ColgateSparkling White Mint Zing232 g in 1 TUBEGEL, DENTIFRICE2328
65954-068-92ColgateSparkling White Mint Zing141 g in 1 TUBEGEL, DENTIFRICE1418
65954-068-92ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QCOLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311COLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJCOLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCOLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOCOLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICOLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65954-068COLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]8Current NDC, Legacy NDC, 18 package rows20241127_56b96f8f-4f75-4762-ae2c-4064543e46d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN56b96f8f-4f75-4762-ae2c-4064543e46d88
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD56b96f8f-4f75-4762-ae2c-4064543e46d88
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY56b96f8f-4f75-4762-ae2c-4064543e46d88
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY56b96f8f-4f75-4762-ae2c-4064543e46d88
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY56b96f8f-4f75-4762-ae2c-4064543e46d88
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY56b96f8f-4f75-4762-ae2c-4064543e46d88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-068-4665954006846130 g in 1 TUBE130 gHistorical
65954-068-48659540068481 TUBE in 1 CARTON (65954-068-48) / 226 g in 1 TUBE1 tube2013-03-01NoNoCurrent
65954-068-58659540068581 TUBE in 1 CARTON (65954-068-58) / 70 g in 1 TUBE1 tube2013-03-01NoNoCurrent
65954-068-60659540068601 TUBE in 1 CARTON (65954-068-60) / 170 g in 1 TUBE1 tube2013-03-01NoNoCurrent
65954-068-6465954006864181 g in 1 TUBE181 gHistorical
65954-068-69659540068691 TUBE in 1 CARTON (65954-068-69) / 113 g in 1 TUBE1 tube2013-03-01NoNoCurrent
65954-068-79659540068791 in 1 CARTONHistorical
65954-068-82659540068821 in 1 CARTONHistorical
65954-068-9265954006892141 g in 1 TUBE141 gHistorical