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 43 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Total Care Zero Alcohol Anticavity Fresh MintSODIUM FLUORIDEKenvue Brands LLC4b594a6e-db1d-443b-bfa7-23ee15749f472024-12-19WarningsExact identifier
application number: M021
NewYork-Presbyterian AmenitySODIUM MONOFLUOROPHOSPATEASP Global, LLc4b307471-445d-4c51-a499-d074a8172f202024-12-17WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
application number: M021
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG03ec09f9-4281-9ccb-e063-6294a90aadd82024-12-01WarningsExact identifier
application number: M021
CURODONT PROTECTSTANNOUS FLUORIDECREDENTIS AG03ec591c-68c3-a380-e063-6394a90a131a2024-12-01WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Bubble Gum BlowoutSODIUM FLUORIDEChattem, Inc.61f3a3e6-645b-4368-b1d5-7de1fc14542e2024-12-01WarningsExact identifier
application number: M021
SparkleFresh Flouride ToothpasteSODIUM MONOFLUOROPHOSPHATEMedline Industries, LP1565528b-89f2-4c97-b294-15b6ebd3f80e2024-11-26WarningsExact identifier
application number: M021
Rembrandt Intense StainSODIUM FLUORIDERanir LLC55dcd063-5661-35aa-e054-00144ff8d46c2024-11-26WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLC9f98913f-6754-4e1c-98cf-b89fe87750f82024-11-25WarningsExact identifier
application number: M021
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company88f87f7a-5b2d-47c9-8830-6b88b4ddbb592024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC0c85d273-3b98-43ea-81ba-c90f70ab72f82024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC2a882210-49e6-4b9c-a2c6-eaa37b6514c32024-11-25WarningsExact identifier
application number: M021
Pepsodent Complete Care OriginalSODIUM FLUORIDEChurch & Dwight Co., Inc.3c6931cb-0ec9-41bb-b410-c355573aab572024-11-21WarningsExact identifier
application number: M021
Firefly Strawberry Natural FluorideSODIUM FLUORIDERanir LLC8ee37955-fe1a-4964-ac29-d1d7dfb694cc2024-11-21WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCabdc7f79-5f87-4307-8ddd-e6281ac67a042024-11-20WarningsExact identifier
application number: M021
AIM Bubble BerrySODIUM FLUORIDEChurch & Dwight Co., Inc.c83ccdea-d75f-4084-853e-ed4bab9a12d42024-11-20WarningsExact identifier
application number: M021
AIM TARTAR CONTROL Plus Mouthwash and WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fc71c-d28e-4afa-e054-00144ff8d46c2024-11-20WarningsExact identifier
application number: M021
Advance White Tartar Control Breath FresheningSODIUM FLUORIDEChurch & Dwight Co., Inc.aa8be8f5-ba46-4b1b-afaa-58fddf8f87802024-11-20WarningsExact identifier
application number: M021
Enamel DefenseSODIUM FLUORIDEChurch & Dwight Co., Inc.9e8f1ce9-b161-50db-e053-2995a90ad32b2024-11-20WarningsExact identifier
application number: M021
Rembrandt Deeply White Plus PeroxideSODIUM MONOFLUOROPHOSPHATERanir LLCbf7da007-ab9d-4631-bc28-6ca245fd62652024-11-20WarningsExact 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