FDA.reportPublic FDA data

Colgate

Product NDC
35000-919
11-digit product format
350000919
Labeler code
35000
Product ID
35000-919_462b5a13-1dde-4fbe-9973-714779774bef
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
COLGATE PALMOLIVE COMPANY
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
35000-919-46ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE13
35000-919-46ColgateSparkling White Mint Zing130 g in 1 TUBEGEL, DENTIFRICE1303
35000-919-48ColgateSparkling White Mint Zing226 g in 1 TUBEGEL, DENTIFRICE2263
35000-919-48ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE13
35000-919-58ColgateSparkling White Mint Zing70 g in 1 TUBEGEL, DENTIFRICE703
35000-919-58ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE13
35000-919-60ColgateSparkling White Mint Zing170 g in 1 TUBEGEL, DENTIFRICE1703
35000-919-60ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE13
35000-919-64ColgateSparkling White Mint Zing181 g in 1 TUBEGEL, DENTIFRICE1813
35000-919-64ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE13
35000-919-69ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE13
35000-919-69ColgateSparkling White Mint Zing113 g in 1 TUBEGEL, DENTIFRICE1133
35000-919-79ColgateSparkling White Mint Zing79 g in 1 TUBEGEL, DENTIFRICE793
35000-919-79ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE13
35000-919-82ColgateSparkling White Mint Zing232 g in 1 TUBEGEL, DENTIFRICE2323
35000-919-82ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE13
35000-919-92ColgateSparkling White Mint Zing141 g in 1 TUBEGEL, DENTIFRICE1413
35000-919-92ColgateSparkling White Mint Zing1 in 1 CARTONGEL, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-919COLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [COLGATE PALMOLIVE COMPANY]3Current NDC, Legacy NDC, 18 package rows20241127_0c2fe62b-4905-4213-a85b-e073d8eeb741.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN0c2fe62b-4905-4213-a85b-e073d8eeb7413
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD0c2fe62b-4905-4213-a85b-e073d8eeb7413
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY0c2fe62b-4905-4213-a85b-e073d8eeb7413
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY0c2fe62b-4905-4213-a85b-e073d8eeb7413
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY0c2fe62b-4905-4213-a85b-e073d8eeb7413
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY0c2fe62b-4905-4213-a85b-e073d8eeb7413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-919-46350000919461 TUBE in 1 CARTON (35000-919-46) > 130 g in 1 TUBE1 tube2013-03-010000-00-00NoNoCurrent
35000-919-48350000919481 TUBE in 1 CARTON (35000-919-48) / 226 g in 1 TUBE1 tube2013-03-010000-00-00NoNoCurrent
35000-919-58350000919581 TUBE in 1 CARTON (35000-919-58) / 70 g in 1 TUBE1 tube2013-03-010000-00-00NoNoCurrent
35000-919-60350000919601 TUBE in 1 CARTON (35000-919-60) / 170 g in 1 TUBE1 tube2013-03-010000-00-00NoNoCurrent
35000-919-64350000919641 TUBE in 1 CARTON (35000-919-64) > 181 g in 1 TUBE1 tube2013-03-010000-00-00NoNoCurrent
35000-919-69350000919691 TUBE in 1 CARTON (35000-919-69) / 113 g in 1 TUBE1 tube2013-03-010000-00-00NoNoCurrent
35000-919-79350000919791 TUBE in 1 CARTON (35000-919-79) > 79 g in 1 TUBE1 tube2013-03-010000-00-00NoNoCurrent
35000-919-82350000919821 TUBE in 1 CARTON (35000-919-82) > 232 g in 1 TUBE1 tube2013-03-010000-00-00NoNoCurrent
35000-919-92350000919921 TUBE in 1 CARTON (35000-919-92) > 141 g in 1 TUBE1 tube2013-03-010000-00-00NoNoCurrent