FDA.reportPublic FDA data

Application 020231

Type
NDA
Sponsor
COLGATE PALMOLIVE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COLGATE TOTALSODIUM FLUORIDE; TRICLOSANPASTE;DENTAL0.24%;0.3%YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-09-29 23:25 UTC2022-09N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11e64feba35796…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35000-002Colgate Total WhiteningSodium Fluoride and TriclosanColgate-PalmoliveNDACurrent
35000-002Colgate Total WhiteningSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-003ColgateSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-003ColgateSodium Fluoride and TriclosanColgate-PalmoliveNDACurrent
35000-004Colgate Total Advanced Fresh plus WhiteningSODIUM FLUORIDE and TRICLOSANColgate-PalmoliveNDACurrent
35000-004Colgate Total Advanced Fresh plus WhiteningSODIUM FLUORIDE and TRICLOSANColgate-Palmolive CompanyNDACurrent
35000-021ColgateSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-021ColgateSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-161Colgate Total Fresh Mint StripeSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-161Colgate Total Fresh Mint StripeSodium Fluoride and TriclosanColgate-PalmoliveNDACurrent
35000-161Colgate Total Fresh Mint StripeSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-168Colgate Total Daily RepairSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-168Colgate Total Daily RepairSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-168Colgate Total Daily RepairSodium Fluoride and TriclosanColgate-PalmoliveNDACurrent
35000-353Colgate Total Advanced Deep CleanSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-353Colgate Total Advanced Deep CleanSodium Fluoride and TriclosanColgate-PalmoliveNDACurrent
35000-354Colgate Total Advanced WhiteningSodium Fluoride and TriclosanColgate-PalmoliveNDACurrent
35000-354Colgate Total Advanced WhiteningSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-354Colgate Total Advanced WhiteningSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-364ColgateSodium Fluoride and TriclosanColgate-PalmoliveNDACurrent
35000-364ColgateSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-384Colgate Total Clean in BetweenSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-384Colgate Total Clean in BetweenSodium Fluoride and TriclosanColgate-PalmoliveNDACurrent
35000-384Colgate Total Clean in BetweenSodium Fluoride and TriclosanColgate-Palmolive CompanyNDACurrent
35000-570ColgateSodium Fluoride and TriclosanColgate-PalmoliveNDACurrent
65954-002ColgateSodium Fluoride and TriclosanMission Hills, S.A. de C.V.NDACurrent
65954-003ColgateSodium Fluoride and TriclosanMission Hills, S.A. de C.V.NDACurrent
65954-353ColgateSODIUM FLUORIDE and TRICLOSANColgate-Palmolive CompanyNDACurrent
65954-354ColgateSODIUM FLUORIDE and TRICLOSANColgate-Palmolive CompanyNDACurrent
67659-300Total WhiteningSodium Fluoride and TriclosanTeam Technologies, IncNDACurrent
67659-310Colgate Total Whitening GelSodium Fluoride and TriclosanTeam Technologies, IncNDACurrent
67659-320Colgate Total Fresh Mint StripeSodium Fluoride and TriclosanTeam Technologies, IncNDACurrent
67659-350ColgateSodium Fluoride and TriclosanTeam Technologies, IncNDACurrent
67659-360Colgate Total Advanced WhiteningSodium Fluoride and TriclosanTeam Technologies, IncNDACurrent
67751-131Colgate Total Clean Mint ANTIGINGIVITISSODIUM FLUORIDENavajo Manufacturing Company IncNDACurrent
67751-131Colgate Total Clean Mint ANTIGINGIVITISSODIUM FLUORIDENavajo Manufacturing Company IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
12334SUPPL2016-04-11
2202SUPPL2016-03-29
12333SUPPL2014-08-05
12332SUPPL2014-08-05
24612SUPPL2014-06-17
2201SUPPL2014-06-17
24610SUPPL2010-09-20
24611SUPPL2009-02-23
20542ORIG2008-09-25
2200SUPPL2008-01-09
24608SUPPL2007-11-19
24607SUPPL2007-11-19
2199SUPPL2007-10-22
24609SUPPL2007-09-25
2198SUPPL2007-09-25
34393SUPPL2007-09-11
34392SUPPL2007-03-23
24606SUPPL2007-03-23
2197SUPPL2007-03-23
2196SUPPL2006-09-20
24605SUPPL2006-04-25
2195SUPPL2005-11-17
34391SUPPL2005-08-08
24604SUPPL2005-08-08
2194SUPPL2005-02-03
2193SUPPL2004-04-20
2192SUPPL2003-12-02
2190SUPPL2003-10-16
34389SUPPL2003-04-22
2191SUPPL2003-04-18
2189SUPPL2002-12-06
2188SUPPL2002-12-06
34390SUPPL2002-04-30
2187SUPPL2002-04-30