Sodium Fluoride / Triclosan Toothpaste

Brand(s)
Colgate Total Advanced
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Colgate-Palmolive Company (2015-09-02)
Oldest Current Product
2008-08-09
License(s)
NDA
RxNORM
TOOTHPASTE\SODIUM FLUORIDE:TRICLOSAN
FDAOB
DENTAL\PASTE\SODIUM FLUORIDE: TRICLOSAN
SPL Active
DENTAL\GEL, DENTIFRICE\SODIUM FLUORIDE: TRICLOSAN
DENTAL\PASTE, DENTIFRICE\SILICON DIOXIDE: SODIUM FLUORIDE: TRICLOSAN
DENTAL\PASTE, DENTIFRICE\SODIUM FLUORIDE: TRICLOSAN
SPL Moiety
DENTAL\GEL, DENTIFRICE\FLUORIDE ION: TRICLOSAN
DENTAL\PASTE, DENTIFRICE\FLUORIDE ION: SILICON DIOXIDE: TRICLOSAN
DENTAL\PASTE, DENTIFRICE\FLUORIDE ION: TRICLOSAN

product(s) by strength(s)

sodium fluoride 0.0024 mg/mg / triclosan 0.003 mg/mg toothpaste

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1350000004Colgate Total AdvancedNDAColgate-Palmolive Company2015-05-15SODIUM FLUORIDE, TRICLOSANDENTALPASTE, DENTIFRICENDA02023152a1e045-0c94-4de4-8a05-9f0724cd0473
2350000021Colgate Total AdvancedNDAColgate-Palmolive Company2010-11-30SILICON DIOXIDE, SODIUM FLUORIDE, TRICLOSANDENTALPASTE, DENTIFRICENDA020231319fc2ff-b86f-4162-acf6-a53716f4fe1e
3350000354Colgate Total AdvancedNDAColgate-Palmolive Company2010-09-21SODIUM FLUORIDE, TRICLOSANDENTALPASTE, DENTIFRICENDA020231748cbe27-5c9f-43b9-b5b6-0b4b1ee0c891
4350000364Colgate Total AdvancedNDAColgate-Palmolive Company2008-08-09SODIUM FLUORIDE, TRICLOSANDENTALPASTE, DENTIFRICENDA020231219a0e97-f89b-4cde-9965-3d25b6896573
5350000570Colgate Total AdvancedNDAColgate-Palmolive Company2011-08-12SODIUM FLUORIDE, TRICLOSANDENTALPASTE, DENTIFRICENDA020231326cec20-b0e0-42c8-b026-80bcc996f86d
6659540002Colgate Total AdvancedNDAMission Hills S.A De C.V2009-10-01SODIUM FLUORIDE, TRICLOSANDENTALGEL, DENTIFRICENDA0202316d23bd9d-7cde-4426-ba24-993a91ace9d0
7659540353Colgate Total AdvancedNDAMission Hills S.A De C.V2009-07-07SODIUM FLUORIDE, TRICLOSANDENTALPASTE, DENTIFRICENDA020231777dbfc2-8cc2-419e-afa8-d4650c0475a2
8659540354Colgate Total AdvancedNDAMission Hills S.A De C.V2009-07-07SODIUM FLUORIDE, TRICLOSANDENTALGEL, DENTIFRICENDA0202312f82bfe9-a861-4051-9133-9c590d09f0b6

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1NDA020231COLGATE TOTALCOLGATE PALMOLIVE1997-07-11NDA020231_001monofluorophosphate / potassium nitrate / ZINC CITRATE Toothpaste

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020231_001OTCTRICLOSAN (0.3%), SODIUM FLUORIDE (0.24%)DENTALPASTETrue1997-07-11COLGATE TOTAL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10c19f549-b64b-487e-b582-e31a3d6bef3c (view SPL)Colgate Total GUM DEFENSEotcHuman OTCColgate-Palmolive Company2011-07-271350000048
2219a0e97-f89b-4cde-9965-3d25b6896573 (view SPL)Colgate Anticavity Fluoride and Antigingivitis ToothpasteotcHuman OTCColgate-Palmolive Company2009-09-081350000364
32f82bfe9-a861-4051-9133-9c590d09f0b6 (view SPL)Colgate Anticavity Fluoride and Antigingivitis ToothpasteotcHuman OTCMission Hills S.A De C.V2009-07-131659540354
4319fc2ff-b86f-4162-acf6-a53716f4fe1e (view SPL)Colgate Total Clean Mint PasteotcHuman OTCColgate-Palmolive Company2011-07-263350000021
5326cec20-b0e0-42c8-b026-80bcc996f86d (view SPL)Colgate Total Advanced Fresh plus WhiteningotcHuman OTCColgate-Palmolive Company2013-01-032350000570
652a1e045-0c94-4de4-8a05-9f0724cd0473 (view SPL)Colgate Total Advanced Fresh plus WhiteningotcHuman OTCColgate-Palmolive Company2015-05-131350000004
756d0b2c6-b45a-4239-8a14-45d44d68f013 (view SPL)Colgate Total Advanced Deep Clean PasteotcHuman OTCColgate-Palmolive Company2015-09-021350000353
86d23bd9d-7cde-4426-ba24-993a91ace9d0 (view SPL)Colgate Total Whitening GelotcHuman OTCMission Hills S.A De C.V2010-09-031659540002
9748cbe27-5c9f-43b9-b5b6-0b4b1ee0c891 (view SPL)Colgate Total Advanced Whitening GelotcHuman OTCColgate-Palmolive Company2015-09-021350000354
10777dbfc2-8cc2-419e-afa8-d4650c0475a2 (view SPL)Colgate Anticavity Fluoride and Antigingivitis ToothpasteotcHuman OTCMission Hills S.A De C.V2009-07-131659540353
117b62ffcf-a7f2-46de-ab8c-88688c984fca (view SPL)Colgate Total Whitening GelotcHuman OTCColgate-Palmolive Company2011-07-263350000002
1287ca035b-f3aa-4477-91d7-1bde3e3e133e (view SPL)Colgate Total Whitening PasteotcHuman OTCMission Hills S.A De C.V2010-09-031659540003
1391b607d3-43e9-4256-8ec0-42c2fd25106a (view SPL)Colgate Total Clean Mint ANTIGINGIVITIS TOOTHPASTEotcHuman OTCNavajo Manufacturing Company Inc.manufacture, relabel, repack2013-06-274677510131
14d7137335-1c85-4d7a-adae-72ff8d63f571 (view SPL)Colgate Total Whitening PasteotcHuman OTCColgate-Palmolive Company2011-07-263350000003
15eeae522f-645c-4a16-8514-37907da323df (view SPL)Colgate Total Fresh Mint Stripe GelotcHuman OTCColgate-Palmolive Company2015-09-151350000161

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII