Home NDC 64854-014-12 BreathRx with Zytex
Product NDC 64854-014
Requested package NDC 64854-014-12
11-digit product format 648540014
Labeler code 64854
Product ID 64854-014_eff84a0d-b41b-ad66-e053-2995a90aa14c
Type HUMAN OTC DRUG
Nonproprietary name Cetylpyridinium Chloride
Dosage form RINSE
Route ORAL
Labeler Discus Dental, LLC
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2006-07-21
Marketing end 0000-00-00
Substance CETYLPYRIDINIUM CHLORIDE
Active strength 1 mg/mL
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 CETYLPYRIDINIUM CHLORIDE ACTIVE INGREDIENT D9OM4SK49P BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 CETYLPYRIDINIUM ACTIVE MOIETY CUB7JI0JV3 BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 EUCALYPTUS OIL INACTIVE INGREDIENT 2R04ONI662 BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 MINT INACTIVE INGREDIENT FV98Z8GITP BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 PEG-40 CASTOR OIL INACTIVE INGREDIENT 4ERD2076EF BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 THYMOL INACTIVE INGREDIENT 3J50XA376E BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 WATER INACTIVE INGREDIENT 059QF0KO0R BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 ZINC GLUCONATE INACTIVE INGREDIENT U6WSN5SQ1Z BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 3 CETYLPYRIDINIUM CHLORIDE ACTIVE INGREDIENT D9OM4SK49P BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 CETYLPYRIDINIUM CHLORIDE ACTIVE INGREDIENT D9OM4SK49P BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 CETYLPYRIDINIUM ACTIVE MOIETY CUB7JI0JV3 BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 CETYLPYRIDINIUM ACTIVE MOIETY CUB7JI0JV3 BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 EUCALYPTUS OIL INACTIVE INGREDIENT 2R04ONI662 BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 EUCALYPTUS OIL INACTIVE INGREDIENT 2R04ONI662 BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 MINT INACTIVE INGREDIENT FV98Z8GITP BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 MINT INACTIVE INGREDIENT FV98Z8GITP BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 PEG-40 CASTOR OIL INACTIVE INGREDIENT 4ERD2076EF BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 PEG-40 CASTOR OIL INACTIVE INGREDIENT 4ERD2076EF BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 THYMOL INACTIVE INGREDIENT 3J50XA376E BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 THYMOL INACTIVE INGREDIENT 3J50XA376E BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 ZINC GLUCONATE INACTIVE INGREDIENT U6WSN5SQ1Z BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1 ZINC GLUCONATE INACTIVE INGREDIENT U6WSN5SQ1Z BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64854-014-12 64854001412 473 mL in 1 BOTTLE, PLASTIC (64854-014-12) 473 ml 2006-07-21 0000-00-00 No No Current