Home NDC 65954-002 Colgate
Product NDC 65954-002
11-digit product format 659540002
Labeler code 65954
Product ID 65954-002_ddb01802-192a-4338-9c6a-c21bae7df346
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride and Triclosan
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Mission Hills, S.A. de C.V.
Application NDA020231
Marketing category NDA
Marketing start 2009-10-01
Marketing end 0000-00-00
Substance SODIUM FLUORIDE; TRICLOSAN
Active strength 2 mg/g; mg/g
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 32 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 65954-002-78 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 65954-002-78 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 65954-002-78 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 65954-002-78 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 65954-002-78 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 65954-002-78 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 65954-002-78 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 65954-002-78 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 65954-002-78 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 65954-002-78 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 65954-002-78 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 65954-002-78 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product U Excluded because listing certification expired 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 65954-002-78 U Excluded because listing certification expired 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product E Excluded after deficient or non-compliant submission was not corrected e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 65954-002-78 E Excluded after deficient or non-compliant submission was not corrected e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product E Excluded after deficient or non-compliant submission was not corrected 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 65954-002-78 E Excluded after deficient or non-compliant submission was not corrected 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 65954-002-78 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020231-001 COLGATE TOTAL SODIUM FLUORIDE; TRICLOSAN 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020231-001 COLGATE TOTAL 0.24%;0.3% PASTE / DENTAL RLD 1997-07-11 e64feba35796…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Sodium Fluoride ACTIVE INGREDIENT 8ZYQ1474W7 COLGATE TOTAL WHITENING (SODIUM FLUORIDE AND TRICLOSAN) GEL, DENTIFRICE [MISSION HILLS, S.A. DE C.V.] 1 Triclosan ACTIVE INGREDIENT 4NM5039Y5X COLGATE TOTAL WHITENING (SODIUM FLUORIDE AND TRICLOSAN) GEL, DENTIFRICE [MISSION HILLS, S.A. DE C.V.] 1 Fluoride Ion ACTIVE MOIETY Q80VPU408O COLGATE TOTAL WHITENING (SODIUM FLUORIDE AND TRICLOSAN) GEL, DENTIFRICE [MISSION HILLS, S.A. DE C.V.] 1 Triclosan ACTIVE MOIETY 4NM5039Y5X COLGATE TOTAL WHITENING (SODIUM FLUORIDE AND TRICLOSAN) GEL, DENTIFRICE [MISSION HILLS, S.A. DE C.V.] 1