Home NDC 54473-293 BreathAway
Product NDC 54473-293
11-digit product format 544730293
Labeler code 54473
Product ID 54473-293_a13cc0a7-9938-05ff-e053-2a95a90aea0d
Type HUMAN OTC DRUG
Nonproprietary name Cetylpyridinium Chloride
Dosage form MOUTHWASH
Route TOPICAL
Labeler Melaleuca, Inc.
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2011-05-02
Marketing end 0000-00-00
Substance CETYLPYRIDINIUM CHLORIDE
Active strength 0 g/473mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CETYLPYRIDINIUM CHLORIDE ACTIVE INGREDIENT D9OM4SK49P BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 CETYLPYRIDINIUM ACTIVE MOIETY CUB7JI0JV3 BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 ETHYL MENTHANE CARBOXAMIDE INACTIVE INGREDIENT 6S7S02945H BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 MYRRH OIL INACTIVE INGREDIENT H74221J5J4 BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 POLYOXYL 40 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 7YC686GQ8F BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 TEA TREE OIL INACTIVE INGREDIENT VIF565UC2G BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1 ZINC CITRATE INACTIVE INGREDIENT K72I3DEX9B BREATHAWAY MOUTH RINSE CINNAMON (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54473-293-08 54473029308 237 mL in 1 BOTTLE (54473-293-08) 237 ml 2018-01-01 0000-00-00 No No Current 54473-293-16 54473029316 473 mL in 1 BOTTLE (54473-293-16) 473 ml 2018-01-01 0000-00-00 No No Current