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 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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

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