Colgate

Product NDC
35000-919
11-digit product format
350000919
Labeler code
35000
Product ID
35000-919_0d589e2c-3d03-4c65-b2ce-bc197b954fb4
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-91935000-919-46DDiscontinued by firm2026-10-16
excluded packagepackage35000-91935000-919-64DDiscontinued by firm2026-10-16
excluded packagepackage35000-91935000-919-79DDiscontinued by firm2026-10-16
excluded packagepackage35000-91935000-919-82DDiscontinued by firm2026-10-16
excluded packagepackage35000-91935000-919-92DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0535000-919-79d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-919-92d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-919-64d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-919-82d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-919-46d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2635000-919-79f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-919-92f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-919-64f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-919-82f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-919-46f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3135000-919-792ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-919-922ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-919-642ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-919-822ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-919-462ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2835000-919-79a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-919-92a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-919-64a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-919-82a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-919-46a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2135000-919-79cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-919-92cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-919-64cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-919-82cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-919-46cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1035000-919-79cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-919-92cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-919-64cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-919-82cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-919-46cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3135000-919-79302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-919-92302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-919-64302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-919-82302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-919-46302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2035000-919-79ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-919-92ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-919-64ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-919-82ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-919-46ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1035000-919-790efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-919-920efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-919-640efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-919-820efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-919-460efc9e666f02…f202fb6c5f17…

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
Brand name suffix
Sparkling White Mint Zing
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 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
0c2fe62b-4905-4213-a85b-e073d8eeb741Available on FDA.report

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

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 37 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cloveden 100 times higher concentratedCETYLPYRIDINIUM CHLORIDEAcuseplanet Inc3c0e1862-293f-4d23-e063-6294a90a33e12025-08-10WarningsExact identifier
application number: M021
Ipana Wintergreen FluorideSODIUM MONOFLUOROPHOSPHATEMaxill Inc.5776cc3e-4fd1-4bd7-8d82-f82508e6b8d02025-07-28WarningsExact identifier
application number: M021
Ipana Bucky Beaver Bubble Gum Childrens FluorideSODIUM MONOFLUOROPHOSPHATEMaxill Ince7aa2a8d-7140-4718-bf69-917bb50d32c72025-07-28WarningsExact identifier
application number: M021
Dubai Chocolate FlavorANTICAVITY TOOTHPASTESuperMouth, LLC.d1615a53-ecfc-49d1-b836-f7643b9d26602025-07-24WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Mint BurstSODIUM FLUORIDEChattem, Inc.0c7ede82-3b28-40ae-8dfd-cec58825f9382025-07-23WarningsExact identifier
application number: M021
Dubai Chocolate Fluoride MouthwashANTICAVITY MOUTHWASHSuperMouth, LLC.ef81a983-64c1-4913-9235-25451f0238522025-07-23WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Cool MintSODIUM FLUORIDEChattem, Inc.3409a749-4a1a-4950-8c21-364d1b977af72025-07-22WarningsExact identifier
application number: M021
Act Total Care Anticavity Fluoride Fresh MintSODIUM FLUORIDEChattem, Inc.dc209500-2bf4-42fb-b3a1-d0fb8d63dbd82025-07-22WarningsExact identifier
application number: M021
Brush Buddies Oral Rinse Sparkle MintSODIUM FLUORIDEASHTEL STUDIOS, INCfe2c06fc-6497-4888-877f-1a88e02fad202025-07-15WarningsExact identifier
application number: M021
evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDESODIUM FLUORIDEAshtel Studios, Inc.1620c7fa-2af6-4462-af5d-9e122942788a2025-07-15WarningsExact identifier
application number: M021
Dentalclean Green Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda5653aa33-4f0e-46b2-9be0-6219143556ec2025-07-14WarningsExact identifier
application number: M021
Colgate Total Gum Protect Fresh MintSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY570e3bd6-eede-4270-9d78-055aeb2b8c172025-07-14WarningsExact identifier
application number: M021
OraPro Fluoride AnticavityFLUORIDE TOOTHPASTEProtegera, Inc.93b0181c-e29f-42f4-80f5-366463b68f092025-07-10WarningsExact identifier
application number: M021
Enamur Fluoride AntiCavity ToothpastFLUORIDE TOOTHPASTProtegera, Inc557ced45-f54e-43d8-aa13-46f75b79367c2025-07-10WarningsExact identifier
application number: M021
Super StrawberrySTRAWBERRY TOOTHPASTESuperMouth, LLC.a8c2b68d-d28b-41c0-a383-cc706b25aa1a2025-07-05WarningsExact identifier
application number: M021
Super MintSUPER MINT TOOTHPASTESuperMouth, LLC.be0915f3-36c4-4200-9d15-704cfbd632b42025-07-05WarningsExact identifier
application number: M021
Super VanillaVANILLA TOOTHPASTESuperMouth, LLC.3ddfe20a-86f1-4566-bb77-82c9749411f62025-07-05WarningsExact identifier
application number: M021
Super ChocolateCHOCOLATE TOOTHPASTESuperMouth, LLC.48607622-7c5e-4ddc-8d83-707f26c0553f2025-07-05WarningsExact identifier
application number: M021
Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINTSODIUM FLUORIDEAshtel Studios, Inc.13dba3ce-88a8-490c-a906-cfd206d1d2902025-07-01WarningsExact identifier
application number: M021
evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINTSODIUM FLUORIDEAshtel Studios, Inc.baae4f4a-54ef-472a-9c94-31703435750b2025-07-01WarningsExact identifier
application number: M021

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