FDA.reportPublic FDA data

Colgate Total Daily Repair

Manufacturer
Colgate-Palmolive Company | Colgate-Palmolive
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:25:27

Label at a glance#

ProductColgate Total Daily Repair
Active ingredientSODIUM FLUORIDE, TRICLOSAN
Label structure6 sections

Indications and uses

aids in the prevention of: cavities plaque gingivitis

Label contents#

Full prescribing information#

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. 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 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. 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, titanium dioxide

Questions or comments?

SPL UNCLASSIFIED SECTION

Call toll-free 1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®

DAILY REPAIR

  • CAVITIES
  • PLAQUE
  • GINGIVITIS
  • ENAMEL
  • TARTAR
  • BREATH
  • WHITENS

Paste

NET WT 4.0 OZ (113 g)

HELPS REVERSE EARLY DAMAGE FOR BETTER ORAL HEALTH

PRINCIPAL DISPLAY PANEL - 113 g Tube Label
PRINCIPAL DISPLAY PANEL - 113 g Tube Label

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
35000-16835000-168-16, 35000-168-69, 35000-168-10, 35000-168-87, 35000-168-67

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
SODIUM FLUORIDE8ZYQ1474W7ACTIM
TRICLOSAN4NM5039Y5XACTIB
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
TITANIUM DIOXIDE15FIX9V2JPIACT
CARRAGEENAN5C69YCD2YJIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT

Source Document#

Source XML · Source PDF

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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11c2088c7a36db…
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…

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
d51ecb55-a8a1-4822-bee1-bd616a7484af933a6e9b-06a6-4fca-bd28-40362cfbec902019-12-09WarningsExact identifier
spl set id: 933a6e9b-06a6-4fca-bd28-40362cfbec90

Reported adverse events (FAERS/openFDA)#

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