Home NDC 35000-206-20 Colgate Enamel Health Sensitivity Relief
Product NDC 35000-206
Requested package NDC 35000-206-20
11-digit product format 350000206
Labeler code 35000
Product ID 35000-206_99e12e24-1c9e-44d5-bd5c-61e68e85479e
Type HUMAN OTC DRUG
Nonproprietary name POTASSIUM NITRATE and SODIUM FLUORIDE
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Colgate-Palmolive
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2014-06-30
Marketing end 2023-09-30
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 50 mg/g; mg/g
NDC exclude flag No
Listing certified through 0000-00-00
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 ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 NITRATE ION ACTIVE MOIETY T93E9Y2844 COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 MICA INACTIVE INGREDIENT V8A1AW0880 COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 POLYETHYLENE GLYCOL 600 INACTIVE INGREDIENT NL4J9F21N9 COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 SODIUM PYROPHOSPHATE INACTIVE INGREDIENT O352864B8Z COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 WATER INACTIVE INGREDIENT 059QF0KO0R COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1 ZINC PHOSPHATE INACTIVE INGREDIENT 1E2MCT2M62 COLGATE ENAMEL HEALTH SENSITIVITY RELIEF (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 35000-206-20 35000020620 1 TUBE in 1 CARTON (35000-206-20) > 24 g in 1 TUBE 1 tube 2014-06-30 2023-09-30 No No Current