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 32 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec2025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC8b28b857-9162-4065-b0a0-571efffe97872025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste OrthoSODIUM FLUORIDEDr Jen Natural, LLC9dd248bf-9488-43cd-a041-e8315a05ce5d2025-12-04WarningsExact identifier
application number: M021
Dr. Jen SuperPaste PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
application number: M021
Colgate Total Plaque CleanseSTANNOUS FLUORIDEColgate-Palmolive Companyb2980238-5bcb-467f-9e90-a307938632c22025-12-03WarningsExact identifier
application number: M021
Advance White Extreme Whitening Tartar ControlSODIUM FLUORIDEChurch & Dwight Co., Inc.b539264f-e1ff-440b-af76-84266fe2c0a22025-12-02WarningsExact identifier
application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh BreathPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC34a1a32e-3017-f018-e063-6394a90a02302025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDE AND POTASSIUM NITRATEBenco Dental4e470ba4-60bb-1815-e063-6294a90abacc2025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDEBenco Dental4e539cb2-bcbd-95fc-e063-6294a90a21212025-12-01WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDONG IL PHARMS CO., LTD.44763bf6-caf3-ec69-e063-6394a90a0ee12025-11-25WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD44765e86-2eb2-6381-e063-6394a90a761f2025-11-25WarningsExact identifier
application number: M021
TheraBreath for Kids Anticavity Wacky WatermelonSODIUM FLUORIDEChurch & Dwight Co., Inc.578f8010-6b1c-4c6b-91d3-e483ace40f662025-11-25WarningsExact identifier
application number: M021
Sensodyne Cavity and SensitivityPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCd002074b-0580-4247-b3c7-121b8c0986972025-11-24WarningsExact identifier
application number: M021
CVS Pharmacy Enamel GuardFLUORIDECVS Pharmacy18295a1c-c2a6-489b-be34-9252b9e1e2b82025-11-21WarningsExact identifier
application number: M021
365 Everyday Value Cavity Fighting and WhiteningSODIUM MONOFLOUROPHOSPHATEWhole Foods Market, Inc.83704717-19bc-2634-e053-2991aa0a29792025-11-21WarningsExact identifier
application number: M021
WhiteningMONOFLUOROPHOSPHATETarget0074630f-9d8d-9209-e063-6294a90a4f012025-11-21WarningsExact identifier
application number: M021
Rite Aid Enamel GuardFLUORIDERite Aid67c1fc04-0f21-4944-8b9d-0d8ffd0518742025-11-21WarningsExact identifier
application number: M021
ME MOTHER EARTHZERO WASTE TOOTHPASTE TABLETS PEPPERMINTA PLUS MERCHANDISE LLC43d30abc-889a-5377-e063-6294a90ab8042025-11-17WarningsExact identifier
application number: M021
Natural White Sensitivity and GumSTANNOUS FLUORIDELornamead Products2e83bda8-4d4b-640f-e063-6294a90abc602025-11-14WarningsExact identifier
application number: M021
CVS Pharmacy Restore and DefendFLUORIDECVS Pharmacy99f86135-05b7-42b1-aef5-df4513259b8f2025-11-14WarningsExact 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