Home NDC 64854-018-01 BreathRx with Zytex
Product NDC 64854-018
Requested package NDC 64854-018-01
11-digit product format 648540018
Labeler code 64854
Product ID 64854-018_eff877d7-3c87-c1b0-e053-2995a90a46af
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Discus Dental, LLC
Application part355
Marketing category OTC MONOGRAPH FINAL
Marketing start 2005-11-21
Marketing end 0000-00-00
Substance SODIUM FLUORIDE
Active strength 2 mg/g
NDC exclude flag No
Listing certified through 2023-12-31
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 SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 FLUORIDE ION ACTIVE MOIETY Q80VPU408O BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 FLUORIDE ION ACTIVE MOIETY Q80VPU408O BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 CARBOXYMETHYLCELLULOSE INACTIVE INGREDIENT 05JZI7B19X BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 CARBOXYMETHYLCELLULOSE INACTIVE INGREDIENT 05JZI7B19X BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 EUCALYPTUS OIL INACTIVE INGREDIENT 2R04ONI662 BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 EUCALYPTUS OIL INACTIVE INGREDIENT 2R04ONI662 BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 MICA INACTIVE INGREDIENT V8A1AW0880 BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 MICA INACTIVE INGREDIENT V8A1AW0880 BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 MINT INACTIVE INGREDIENT FV98Z8GITP BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 MINT INACTIVE INGREDIENT FV98Z8GITP BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 POLYETHYLENE GLYCOL 600 INACTIVE INGREDIENT NL4J9F21N9 BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 POLYETHYLENE GLYCOL 600 INACTIVE INGREDIENT NL4J9F21N9 BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 POTASSIUM PYROPHOSPHATE INACTIVE INGREDIENT B9W4019H5G BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 POTASSIUM PYROPHOSPHATE INACTIVE INGREDIENT B9W4019H5G BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 SODIUM METHYL COCOYL TAURATE INACTIVE INGREDIENT JVL98CG53G BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 SODIUM METHYL COCOYL TAURATE INACTIVE INGREDIENT JVL98CG53G BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 SODIUM PYROPHOSPHATE INACTIVE INGREDIENT O352864B8Z BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 SODIUM PYROPHOSPHATE INACTIVE INGREDIENT O352864B8Z BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 THYMOL INACTIVE INGREDIENT 3J50XA376E BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 THYMOL INACTIVE INGREDIENT 3J50XA376E BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 ZINC GLUCONATE INACTIVE INGREDIENT U6WSN5SQ1Z BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2 ZINC GLUCONATE INACTIVE INGREDIENT U6WSN5SQ1Z BREATHRX WITH ZYTEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DISCUS DENTAL, LLC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64854-018-01 64854001801 112 g in 1 TUBE (64854-018-01) 112 g 2005-11-21 0000-00-00 No No Current