Home NDC 65954-046-02 Colgate Sensitive Multiprotection
Product NDC 65954-046
Requested package NDC 65954-046-02
11-digit product format 659540046
Labeler code 65954
Product ID 65954-046_4cdf7b1c-a409-4a32-a277-310893e79f0e
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE and POTASSIUM NITRATE
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Mission Hills S.A de C.V
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2010-01-12
Marketing end 0000-00-00
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength 1 mg/g; mg/g
NDC exclude flag No
Listing certified through 2020-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POTASSIUM NITRATE ACTIVE INGREDIENT RU45X2JN0Z COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 POTASSIUM NITRATE ACTIVE INGREDIENT RU45X2JN0Z COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 NITRATE ION ACTIVE MOIETY T93E9Y2844 COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 POTASSIUM CATION ACTIVE MOIETY 295O53K152 COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 carboxymethylcellulose sodium INACTIVE INGREDIENT K679OBS311 COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 cocamidopropyl betaine INACTIVE INGREDIENT 5OCF3O11KX COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 hydrated silica INACTIVE INGREDIENT Y6O7T4G8P9 COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 POLYETHYLENE GLYCOL 600 INACTIVE INGREDIENT NL4J9F21N9 COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 sodium pyrophosphate INACTIVE INGREDIENT O352864B8Z COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 SODIUM PYROPHOSPHATE INACTIVE INGREDIENT O352864B8Z COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 sodium tripolyphosphate INACTIVE INGREDIENT 5HK03SA80J COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 SODIUM TRIPOLYPHOSPHATE INACTIVE INGREDIENT 5HK03SA80J COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 sorbitol INACTIVE INGREDIENT 506T60A25R COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 water INACTIVE INGREDIENT 059QF0KO0R COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE COLGATE SENSITIVE MULTIPROTECTION (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 1 xanthan gum INACTIVE INGREDIENT TTV12P4NEE COLGATE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A. DE C.V.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65954-046-02 65954004602 1 TUBE in 1 CARTON (65954-046-02) > 59 g in 1 TUBE 1 tube 2010-06-21 0000-00-00 No No Current