BreathRx with Zytex

Product NDC
64854-014
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 18 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64854-014DDiscontinued by firm2026-10-05
excluded productproduct64854-014DDiscontinued by firm2026-10-05
excluded productproduct64854-014DDiscontinued by firm2026-10-05
excluded productproduct64854-014DDiscontinued by firm2026-10-05
excluded productproduct64854-014DDiscontinued by firm2026-10-05
excluded productproduct64854-014DDiscontinued by firm2026-10-05
excluded productproduct64854-014DDiscontinued by firm2026-10-05
excluded packagepackage64854-01464854-014-11DDiscontinued by firm2026-10-05
excluded packagepackage64854-01464854-014-12DDiscontinued by firm2026-10-05
excluded packagepackage64854-01464854-014-13DDiscontinued by firm2026-10-05
excluded packagepackage64854-01464854-014-14DDiscontinued by firm2026-10-05
excluded packagepackage64854-01464854-014-06DDiscontinued by firm2026-10-05
excluded packagepackage64854-01464854-014-03DDiscontinued by firm2026-10-05
excluded packagepackage64854-01464854-014-07DDiscontinued by firm2026-10-05
excluded packagepackage64854-01464854-014-02DDiscontinued by firm2026-10-05
excluded packagepackage64854-01464854-014-10DDiscontinued by firm2026-10-05
excluded packagepackage64854-01464854-014-20DDiscontinued by firm2026-10-05
excluded packagepackage64854-01464854-014-04DDiscontinued by firm2026-10-05

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 4 · 216 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64854-014-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64854-014-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64854-014-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64854-014-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64854-014-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64854-014-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64854-014-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64854-014-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64854-014-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64854-014-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64854-014-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64854-014-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64854-014-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64854-014-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64854-014-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64854-014-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64854-014-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64854-014-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64854-014-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64854-014-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64854-014-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64854-014-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64854-014-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64854-014-112ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64854-014-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64854-014-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64854-014-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64854-014-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64854-014-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64854-014-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64854-014-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64854-014-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64854-014-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49PBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV3BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
MINTINACTIVE INGREDIENTFV98Z8GITPBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
PEG-40 CASTOR OILINACTIVE INGREDIENT4ERD2076EFBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
SORBITOLINACTIVE INGREDIENT506T60A25RBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
THYMOLINACTIVE INGREDIENT3J50XA376EBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
ZINC GLUCONATEINACTIVE INGREDIENTU6WSN5SQ1ZBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]3
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49PBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49PBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV3BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV3BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
MINTINACTIVE INGREDIENTFV98Z8GITPBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
MINTINACTIVE INGREDIENTFV98Z8GITPBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
PEG-40 CASTOR OILINACTIVE INGREDIENT4ERD2076EFBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
PEG-40 CASTOR OILINACTIVE INGREDIENT4ERD2076EFBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
THYMOLINACTIVE INGREDIENT3J50XA376EBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
THYMOLINACTIVE INGREDIENT3J50XA376EBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
ZINC GLUCONATEINACTIVE INGREDIENTU6WSN5SQ1ZBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1
ZINC GLUCONATEINACTIVE INGREDIENTU6WSN5SQ1ZBREATHRX WITH ZYTEX (CETYLPYRIDINIUM CHLORIDE) RINSE [DISCUS DENTAL, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64854-014-0264854001402976 mL in 1 BOTTLE, PLASTIC (64854-014-02) 976 ml2006-07-210000-00-00NoNoCurrent
64854-014-03648540014033785 mL in 1 BOTTLE, PLASTIC (64854-014-03) 3785 ml2006-07-210000-00-00NoNoCurrent
64854-014-066485400140659 mL in 1 BOTTLE, PLASTIC (64854-014-06) 59 ml2006-07-210000-00-00NoNoCurrent
64854-014-0764854001407237 mL in 1 BOTTLE, PLASTIC (64854-014-07) 237 ml2006-07-210000-00-00NoNoCurrent
64854-014-106485400141059 mL in 1 BOTTLE, PLASTIC (64854-014-10) 59 ml2006-07-210000-00-00NoNoCurrent
64854-014-1164854001411237 mL in 1 BOTTLE, PLASTIC (64854-014-11) 237 ml2006-07-210000-00-00NoNoCurrent
64854-014-1264854001412473 mL in 1 BOTTLE, PLASTIC (64854-014-12) 473 ml2006-07-210000-00-00NoNoCurrent
64854-014-1364854001413976 mL in 1 BOTTLE, PLASTIC (64854-014-13) 976 ml2006-07-210000-00-00NoNoCurrent
64854-014-14648540014143785 mL in 1 BOTTLE, PLASTIC (64854-014-14) 3785 ml2006-07-210000-00-00NoNoCurrent
64854-014-20648540014201 BOTTLE, PLASTIC in 1 PACKAGE (64854-014-20) > 59 mL in 1 BOTTLE, PLASTIC (64854-014-10) 2014-09-010000-00-00NoNoCurrent