FDA.reportPublic FDA data

Colgate

Product NDC
35000-916
11-digit product format
350000916
Labeler code
35000
Product ID
35000-916_5f2598c9-6ba8-46a2-a08b-3fd0f2c408c3
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-12-01
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate
Brand name suffix
ULTRA BRITE Baking Soda and Peroxide Whitening
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1.1 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
35000-916-60ColgateULTRA BRITE Baking Soda and Peroxide Whitening1 in 1 CARTONPASTE, DENTIFRICE13
35000-916-60ColgateULTRA BRITE Baking Soda and Peroxide Whitening170 g in 1 TUBEPASTE, DENTIFRICE1703
35000-916-71ColgateULTRA BRITE Baking Soda and Peroxide Whitening119 g in 1 TUBEPASTE, DENTIFRICE1193
35000-916-71ColgateULTRA BRITE Baking Soda and Peroxide Whitening1 in 1 CARTONPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-916COLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]2Current NDC, Legacy NDC, 4 package rows20241020_2b123d70-4f7d-41b0-b48f-711999e97ee0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN2b123d70-4f7d-41b0-b48f-711999e97ee03
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD2b123d70-4f7d-41b0-b48f-711999e97ee03
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY2b123d70-4f7d-41b0-b48f-711999e97ee03
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY2b123d70-4f7d-41b0-b48f-711999e97ee03
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY2b123d70-4f7d-41b0-b48f-711999e97ee03
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY2b123d70-4f7d-41b0-b48f-711999e97ee03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-916-60350000916601 TUBE in 1 CARTON (35000-916-60) / 170 g in 1 TUBE1 tube2011-12-010000-00-00NoNoCurrent
35000-916-71350000916711 TUBE in 1 CARTON (35000-916-71) / 119 g in 1 TUBE1 tube2026-03-01NoNoHistorical