COLGATE Great Regular Flavor

Product NDC
35000-913
11-digit product format
350000913
Labeler code
35000
Product ID
35000-913_5c864eeb-a3fa-4e6a-b624-29ed3cd6d2da
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
2005-11-05
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-91335000-913-33DDiscontinued by firm2026-10-15
excluded packagepackage35000-91335000-913-46DDiscontinued by firm2026-10-15
excluded packagepackage35000-91335000-913-60DDiscontinued by firm2026-10-15
excluded packagepackage35000-91335000-913-64DDiscontinued by firm2026-10-15
excluded packagepackage35000-91335000-913-79DDiscontinued by firm2026-10-15
excluded packagepackage35000-91335000-913-82DDiscontinued by firm2026-10-15
excluded packagepackage35000-91335000-913-93DDiscontinued by firm2026-10-15

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 · 54 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 2025-12-0535000-913-46d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-913-93d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-913-64d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-913-82d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-913-33d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-913-79d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2635000-913-46f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-913-93f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-913-64f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-913-82f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-913-33f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-913-79f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3135000-913-462ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-913-932ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-913-642ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-913-822ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-913-332ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-913-792ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2835000-913-46a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-913-93a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-913-64a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-913-82a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-913-33a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-913-79a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2135000-913-46cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-913-93cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-913-64cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-913-82cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-913-33cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-913-79cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1035000-913-46cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-913-93cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-913-64cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-913-82cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-913-33cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-913-79cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3135000-913-46302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-913-93302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-913-64302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-913-82302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-913-33302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-913-79302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2035000-913-46ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-913-93ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-913-64ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-913-82ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-913-33ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-913-79ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1035000-913-460efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-913-930efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-913-640efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-913-820efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-913-330efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-913-790efc9e666f02…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 Great Regular Flavor
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
730f40f6-6ac6-49bd-888b-c0b5818a03c8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-913-01COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-01COLGATE Great Regular Flavor28 g in 1 TUBEPASTE, DENTIFRICE283
35000-913-04COLGATE Great Regular Flavor4.25 g in 1 POUCHPASTE, DENTIFRICE4.253
35000-913-20COLGATE Great Regular Flavor24 g in 1 TUBEPASTE, DENTIFRICE243
35000-913-30COLGATE Great Regular Flavor170 g in 1 TUBEPASTE, DENTIFRICE1703
35000-913-30COLGATE Great Regular Flavor3 in 1 CARTONPASTE, DENTIFRICE33
35000-913-33COLGATE Great Regular Flavor36.8 g in 1 TUBEPASTE, DENTIFRICE36.83
35000-913-33COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-46COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-46COLGATE Great Regular Flavor130 g in 1 TUBEPASTE, DENTIFRICE1303
35000-913-48COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-48COLGATE Great Regular Flavor226 g in 1 TUBEPASTE, DENTIFRICE2263
35000-913-58COLGATE Great Regular Flavor70 g in 1 TUBEPASTE, DENTIFRICE703
35000-913-58COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-60COLGATE Great Regular Flavor170 g in 1 TUBEPASTE, DENTIFRICE1703
35000-913-64COLGATE Great Regular Flavor181 g in 1 TUBEPASTE, DENTIFRICE1813
35000-913-64COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-69COLGATE Great Regular Flavor113 g in 1 TUBEPASTE, DENTIFRICE1133
35000-913-69COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-79COLGATE Great Regular Flavor79 g in 1 TUBEPASTE, DENTIFRICE793
35000-913-79COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-82COLGATE Great Regular Flavor232 g in 1 TUBEPASTE, DENTIFRICE2323
35000-913-82COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-92COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-92COLGATE Great Regular Flavor141 g in 1 TUBEPASTE, DENTIFRICE1413
35000-913-93COLGATE Great Regular Flavor99 g in 1 TUBEPASTE, DENTIFRICE993

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-913COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]3Current NDC, Legacy NDC, 26 package rows20241127_730f40f6-6ac6-49bd-888b-c0b5818a03c8.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 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.ed617c7a-805c-4788-9bce-9b7fead4312d2026-03-31WarningsExact identifier
application number: M021
Colgate Total Enamel StrengthSTANNOUS FLUORIDEColgate-Palmolive Company1f29c893-e7c5-4a0e-941b-c2634d8211472026-03-25WarningsExact identifier
application number: M021
AP-24 WhiteningSODIUM MONOFLUOROPHOSPHATENSE Products, Inc.57e9e68c-41dd-470b-80db-dfaedc0e2a0a2026-03-24WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369c0d44-6375-dcae-e063-6394a90a74d02026-03-24WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369bc785-fb77-a56d-e063-6394a90a2e6b2026-03-24WarningsExact identifier
application number: M021
SensitiveToothpasteANTI SENSITIVETOOTHPASTEHuain Best Trade Co., Ltd.4db239f3-2ad7-3a5b-e063-6294a90a11a72026-03-23WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
application number: M021
Natures Promise Childrens Fluoride StrawberrySODIUM MONOFLUOROPHOSPHATEFoodhold U.S.A.81a4e196-8b2d-0745-e053-2991aa0a7de62026-03-16WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae8badf-f960-62fd-e054-00144ff8d46c2026-03-11WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae71258-a8c2-6eb5-e054-00144ff88e882026-03-11WarningsExact identifier
application number: M021
Delta Travel Kit Comfort plusSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.d31e0920-4317-1e0c-e053-2a95a90aebeb2026-03-11WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6caf3f2e-70a2-4530-99fa-f5af7e4c511a2026-03-10WarningsExact identifier
application number: M021
Amerfresh ToothpowderSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD1cacf93e-aa60-4717-87ab-0568a701a4f32026-03-10WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.a51357df-6d55-4030-a5db-42da7ba54a372026-03-09Warnings, Adverse reactionsExact identifier
application number: M021
FluorideFLUORIDE TOOTHPASTEMcKesson4c482e45-0502-a93a-e063-6394a90aa9612026-03-05WarningsExact identifier
application number: M021
Colgate Maximum Cavity Protection Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company0a1389f6-cac9-3d58-0744-c488abb0bbcc2026-03-03WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEAmazon.com Services LLC349eca80-2e0c-409b-af29-3235fdc0695b2026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEAmazon.com Services LLC03735abc-d1be-4ca0-a497-0a5c5f2894022026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.f8036e2e-7541-4922-92b9-0d8319f7b64c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % ToothpastePSNf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYf89bf259-b738-8229-e053-6394a90a0c592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-913-01350000913011 TUBE in 1 CARTON (35000-913-01) / 28 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-04350000913044.25 g in 1 POUCH (35000-913-04) 4.25 g2005-11-050000-00-00NoNoCurrent
35000-913-203500009132024 g in 1 TUBE (35000-913-20) 24 g2005-11-050000-00-00NoNoCurrent
35000-913-30350000913303 TUBE in 1 CARTON (35000-913-30) / 170 g in 1 TUBE3 tube2005-11-05NoNoCurrent
35000-913-33350000913331 TUBE in 1 CARTON (35000-913-33) > 36.8 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-34350000913342 TUBE in 1 CARTON (35000-913-34) / 170 g in 1 TUBE2 tube2024-01-01NoNoCurrent
35000-913-46350000913461 TUBE in 1 CARTON (35000-913-46) > 130 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-48350000913481 TUBE in 1 CARTON (35000-913-48) / 226 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-58350000913581 TUBE in 1 CARTON (35000-913-58) / 70 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-6035000091360170 g in 1 TUBE (35000-913-60) 170 g2005-11-050000-00-00NoNoCurrent
35000-913-62350000913621 TUBE in 1 CARTON (35000-913-62) / 170 g in 1 TUBE1 tube2026-01-01NoNoCurrent
35000-913-64350000913641 TUBE in 1 CARTON (35000-913-64) > 181 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-69350000913691 TUBE in 1 CARTON (35000-913-69) / 113 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-79350000913791 TUBE in 1 CARTON (35000-913-79) > 79 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-82350000913821 TUBE in 1 CARTON (35000-913-82) > 232 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-92350000913921 TUBE in 1 CARTON (35000-913-92) / 141 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent
35000-913-933500009139399 g in 1 TUBE (35000-913-93) 99 g2005-11-050000-00-00NoNoCurrent