Colgate Triple Action

Product NDC
35000-941
11-digit product format
350000941
Labeler code
35000
Product ID
35000-941_905181e2-96e2-4b14-9605-47353a251173
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-12-01
Substance
SODIUM FLUORIDE
Active strength
1.1 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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-94135000-941-46DDiscontinued by firm2026-10-15
excluded packagepackage35000-94135000-941-47DDiscontinued by firm2026-10-15
excluded packagepackage35000-94135000-941-63DDiscontinued by firm2026-10-15
excluded packagepackage35000-94135000-941-64DDiscontinued by firm2026-10-15
excluded packagepackage35000-94135000-941-79DDiscontinued by firm2026-10-15
excluded packagepackage35000-94135000-941-82DDiscontinued by firm2026-10-15
excluded packagepackage35000-94135000-941-92DDiscontinued by firm2026-10-15
excluded packagepackage35000-94135000-941-99DDiscontinued 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 · 46 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 2025-12-0535000-941-82d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-941-64d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-941-63d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-941-92d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-941-79d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-941-46d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2635000-941-92f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-941-46f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-941-79f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-941-82f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-941-64f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3135000-941-922ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-941-462ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-941-792ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-941-822ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-941-642ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2835000-941-92a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-941-46a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-941-79a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-941-82a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-941-64a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2135000-941-92cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-941-46cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-941-79cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-941-82cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-941-64cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1035000-941-92cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-941-46cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-941-79cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-941-82cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-941-64cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3135000-941-92302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-941-46302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-941-79302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-941-82302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-941-64302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2035000-941-92ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-941-46ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-941-79ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-941-82ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-941-64ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1035000-941-920efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-941-460efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-941-790efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-941-820efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-941-640efc9e666f02…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 Triple Action
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3082e9ba-66d9-4fc7-bbe6-b41b60939bd2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-941-30Colgate Triple Action3 in 1 CARTONPASTE, DENTIFRICE310
35000-941-30Colgate Triple Action170 g in 1 TUBEPASTE, DENTIFRICE17010
35000-941-46Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE110
35000-941-46Colgate Triple Action130 g in 1 TUBEPASTE, DENTIFRICE13010
35000-941-47Colgate Triple Action133 g in 1 TUBEPASTE, DENTIFRICE13310
35000-941-47Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE110
35000-941-48Colgate Triple Action226 g in 1 TUBEPASTE, DENTIFRICE22610
35000-941-48Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE110
35000-941-58Colgate Triple Action70 g in 1 TUBEPASTE, DENTIFRICE7010
35000-941-58Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE110
35000-941-60Colgate Triple Action170 g in 1 TUBEPASTE, DENTIFRICE17010
35000-941-60Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE110
35000-941-63Colgate Triple Action85 g in 1 TUBEPASTE, DENTIFRICE8510
35000-941-63Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE110
35000-941-64Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE110
35000-941-64Colgate Triple Action181 g in 1 TUBEPASTE, DENTIFRICE18110
35000-941-69Colgate Triple Action113 g in 1 TUBEPASTE, DENTIFRICE11310
35000-941-69Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE110
35000-941-79Colgate Triple Action79 g in 1 TUBEPASTE, DENTIFRICE7910
35000-941-79Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE110
35000-941-82Colgate Triple Action232 g in 1 TUBEPASTE, DENTIFRICE23210
35000-941-82Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE110
35000-941-92Colgate Triple Action141 g in 1 TUBEPASTE, DENTIFRICE14110
35000-941-92Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE110
35000-941-99Colgate Triple Action1 in 1 CARTONPASTE, DENTIFRICE110
35000-941-99Colgate Triple Action99 g in 1 TUBEPASTE, DENTIFRICE9910

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-941COLGATE TRIPLE ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE PALMOLIVE COMPANY]7Current NDC, Legacy NDC, 26 package rows20241127_3082e9ba-66d9-4fc7-bbe6-b41b60939bd2.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 16 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Toms of Maine Whiten Plus Deep Clean PeppermintSODIUM FLUORIDETom's of Maine4c535776-3f80-4eeb-bb63-2d734c3c3a6b2026-02-18WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIdd6bf8df-1e28-4f61-b876-b9f1f8d5993a2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI8283cea0-7b62-4796-8763-6654039664cd2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI9d055fed-26d8-4827-a4cc-8c314514a6c32026-02-17WarningsExact identifier
application number: M021
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.28d1b8c3-930f-4ac9-aa5a-b72b832bb77e2026-02-17WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEValu Merchandisers Company088b95e6-30fd-4263-9fdc-57cd63385b712026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEValu Merchandisers Companye31c1609-a1c3-4ed5-adfd-3cfa63205ec32026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI3602c528-5f53-4d41-bf67-163149f52b352026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIe696038c-182e-4325-9b90-87fe498d9f672026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLC3b04142a-4a65-45ba-a5a2-e62b0c47ec552026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDETopco Associates LLCc640adc0-e178-4b6a-af44-07d2f7da81d32026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLCf760f8f8-0c74-4a6e-b5c9-cc82b8758a452026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDETopco Associates LLCade7dcb2-b4e2-4cef-b9a7-469867ead68a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDETopco Associates LLC84b30711-a7e5-4189-895a-a7989f05591c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity fluoride rinseSODIUM FLUORIDETopco Associates LLCc3f2e952-a8d5-4e9d-a5c6-09e4f25441792026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDETopco Associates LLCa9b8b2fe-0a60-4f65-b6f6-aae8509c919f2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
SaliveaFLUORIDE TOOTHPASTELaclede, Inc.4abb0f80-d87d-730f-e063-6294a90a15f72026-02-13WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchanges581d5cdb-018a-42ad-899d-5331f00633762026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEYour Military Exchanges965911c3-7aa8-4830-8269-6aa5d526ee732026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDEWalgreen Co.eae87899-3eba-4d50-bc31-9eaf54ff9e002026-02-12Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN3082e9ba-66d9-4fc7-bbe6-b41b60939bd210
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3082e9ba-66d9-4fc7-bbe6-b41b60939bd210
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3082e9ba-66d9-4fc7-bbe6-b41b60939bd210
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3082e9ba-66d9-4fc7-bbe6-b41b60939bd210
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3082e9ba-66d9-4fc7-bbe6-b41b60939bd210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-941-30350000941303 TUBE in 1 CARTON (35000-941-30) / 170 g in 1 TUBE3 tube2025-01-01NoNoCurrent
35000-941-46350000941461 TUBE in 1 CARTON (35000-941-46) > 130 g in 1 TUBE1 tube2010-12-010000-00-00NoNoCurrent
35000-941-47350000941471 TUBE in 1 CARTON (35000-941-47) > 133 g in 1 TUBE1 tube2020-12-140000-00-00NoNoCurrent
35000-941-48350000941481 TUBE in 1 CARTON (35000-941-48) / 226 g in 1 TUBE1 tube2010-12-010000-00-00NoNoCurrent
35000-941-58350000941581 TUBE in 1 CARTON (35000-941-58) / 70 g in 1 TUBE1 tube2010-12-010000-00-00NoNoCurrent
35000-941-60350000941601 TUBE in 1 CARTON (35000-941-60) / 170 g in 1 TUBE1 tube2010-12-010000-00-00NoNoCurrent
35000-941-63350000941631 TUBE in 1 CARTON (35000-941-63) > 85 g in 1 TUBE1 tube2010-12-010000-00-00NoNoCurrent
35000-941-64350000941641 TUBE in 1 CARTON (35000-941-64) > 181 g in 1 TUBE1 tube2010-12-010000-00-00NoNoCurrent
35000-941-69350000941691 TUBE in 1 CARTON (35000-941-69) / 113 g in 1 TUBE1 tube2010-12-010000-00-00NoNoCurrent
35000-941-79350000941791 TUBE in 1 CARTON (35000-941-79) > 79 g in 1 TUBE1 tube2010-12-010000-00-00NoNoCurrent
35000-941-82350000941821 TUBE in 1 CARTON (35000-941-82) > 232 g in 1 TUBE1 tube2010-12-010000-00-00NoNoCurrent
35000-941-92350000941921 TUBE in 1 CARTON (35000-941-92) > 141 g in 1 TUBE1 tube2010-12-010000-00-00NoNoCurrent
35000-941-99350000941991 TUBE in 1 CARTON (35000-941-99) > 99 g in 1 TUBE1 tube2020-11-090000-00-00NoNoCurrent