FDA.reportPublic FDA data

Colgate

Manufacturer
Team Technologies, Inc
Effective date
2018-07-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:31

Label at a glance#

ProductColgate Total Advance Whitening
Active ingredientSODIUM FLUORIDE, TRICLOSAN
Label structure10 sections

Indications and uses

aids in the prevention of: cavities plaque gingivitis

Dosage and administration

supervise children as necessary until capable of using without supervision. adults and children 6 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician children under 12 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 6 years do not use unless directed by a dentist or a physician Antip...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Triclosan 0.30%

Purpose

OTC - PURPOSE SECTION

Anticavity

Antigingivitis

Uses

INDICATIONS & USAGE SECTION

aids in the prevention of:

  • cavities
  • plaque
  • gingivitis

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Ask a dentist before use if you have

OTC - ASK DOCTOR SECTION

  • bleeding or redness lasting more than 2 weeks
  • pain, swelling, pus, loose teeth, or more spacing between teeth

These may be signs of periodontitis, a serious form of gum disease.

Directions

DOSAGE & ADMINISTRATION SECTION

supervise children as necessary until capable of using without supervision.

adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician
children under 12 yearsinstruct in good brushing and rinsing habits
(to minimize swallowing)
children under 6 yearsdo not use unless directed by a dentist or a physician

Antiplaque and antigingivitis use not proven in children.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, hydrated silica, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022  Made in U.S.A.
www.colgatetotal.com

PRINCIPAL DISPLAY PANEL - 226 g Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helps Prevent Cavities • Gingivitis • Plaque

Colgate ®
Total ®
Anticavity Fluoride and Antigingivitis Toothpaste

ADVANCED WHITENING
PASTE

HELPS
REMOVE &
PREVENT
STAINS*

ADA
ACCEPTED
American
Dental
Association ®

NET WT 8.0 OZ (226 g)

Principal Display Panel - 226 g Tube
Principal Display Panel - 226 g Tube

PRINCIPAL DISPLAY PANEL - 226 g carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helps Prevent Cavities • Gingivitis • Plaque

Colgate ®
Total®
Anticavity Fluoride and Antigingivitis Toothpaste

ADVANCED WHITENING
PASTE

HELPS
REMOVE &
PREVENT
STAINS*

ADA
ACCEPTED
American
Dental
Association ®

NET WT 8.0 OZ (226 g)

Principal Display Panel - 226 g carton
Principal Display Panel - 226 g carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
894876sodium fluoride 0.24 % / triclosan 0.3 % ToothpastePSN2
894876sodium fluoride 0.0024 MG/MG / triclosan 0.003 MG/MG ToothpasteSCD2
894876sodium fluoride 0.24 % (fluoride ion 0.14 % / triclosan 0.3 % ) ToothpasteSY2
894876sodium fluoride 0.24 % / triclosan 0.3 % ToothpasteSY2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67659-350-062020-01-31C16284748780-19d75b9d0-c430-f424-e053-dadaa90a57ceColgate ® Anticavity Fluoride and Antigingivitis Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67659-350-06ColgateTotal Advance Whitening226 g in 1 TUBEPASTE, DENTIFRICE2262

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67659-350COLGATE TOTAL ADVANCE WHITENING (SODIUM FLUORIDE AND TRICLOSAN) PASTE, DENTIFRICE [TEAM TECHNOLOGIES, INC]2Legacy NDC, 1 package rows20181206_334a3704-d08f-0a85-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67659-35067659-350-06
35000-364

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW)389H2R62BDIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
TRICLOSAN4NM5039Y5XACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020231-001COLGATE TOTALSODIUM FLUORIDE; TRICLOSAN0.24%;0.3%PASTE / DENTALRLD1997-07-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-1184e616aacf4f…
2026-08-18 06:07:402026-07N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-1187673890dc5c…
2021-03-12 10:30 UTC2021-03N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-113f01610625f2…
2019-09-15 20:21 UTC2019-09N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11b00525d2431f…
2019-07-19 19:46 UTC2019-07N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-113f0d92c62455…
2023-05-13 08:27 UTC2023-05N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11053a50430f4f…
2023-01-26 05:58 UTC2023-01N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11f41ea6bd6efb…

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
71c08847-9679-ff89-e053-2a95a90ad9cc334a3704-d08f-0a85-e054-00144ff8d46c2018-07-24WarningsExact identifier
spl id: 71c08847-9679-ff89-e053-2a95a90ad9cc
spl set id: 334a3704-d08f-0a85-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.