FDA.reportPublic FDA data

Colgate ® Total ® Whitening Gel

Manufacturer
Mission Hills, S.A. de C.V.
Effective date
2010-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:52:27

Label at a glance#

ProductColgate Total Whitening
Active ingredientSodium Fluoride, Triclosan
Label structure9 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#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Sodium fluoride 0.24% (0.14% w/v fluoride ion)Anticavity
Triclosan 0.30%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.

OTC - WHEN USING SECTION

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, cellulose gum, flavor, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, mica, titanium dioxide, FD&C blue no.1

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-468-6502

PRINCIPAL DISPLAY PANEL - 221 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helps Prevent Cavities • Gingivitis • Plaque

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®
Whitening
Gel

ADA
Accepted
American
Dental
Association ®

NET WT 7.8 OZ (221 g)

Fights Tartar Buildup • Whitens Teeth

PRINCIPAL DISPLAY PANEL - 221 g Tube Carton
PRINCIPAL DISPLAY PANEL - 221 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65954-002-782019-10-25C16284748780-1956f9ecf-cd5c-621f-e053-dbdaa90a74adColgate ® Total ® Whitening Gel
65954-002-782019-10-21C16284748780-1956f9ecf-cd5c-621f-e053-dbdaa90a74adColgate ® Total ® Whitening Gel

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W71
TriclosanACTIVE INGREDIENT4NM5039Y5X1
Fluoride IonACTIVE MOIETYQ80VPU408O1
TriclosanACTIVE MOIETY4NM5039Y5X1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65954-00265954-002-78

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium Fluoride8ZYQ1474W7ACTIB
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
8764f5b8-d9b4-4bc2-9973-b8fd16928b566d23bd9d-7cde-4426-ba24-993a91ace9d02022-01-14WarningsExact identifier
spl set id: 6d23bd9d-7cde-4426-ba24-993a91ace9d0

Reported adverse events (FAERS/openFDA)#

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