Home NDC 54473-294-08 BreathAway
Product NDC 54473-294
Requested package NDC 54473-294-08
11-digit product format 544730294
Labeler code 54473
Product ID 54473-294_f2053d5d-50f2-f9b2-e053-2a95a90a6d14
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 2024-12-31
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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54473-294-08 BreathAwayMouth Rinse Fresh Mint 237 mL in 1 BOTTLE MOUTHWASH 237 6 54473-294-16 BreathAwayMouth Rinse Fresh Mint 473 mL in 1 BOTTLE MOUTHWASH 473 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CETYLPYRIDINIUM CHLORIDE ACTIVE INGREDIENT D9OM4SK49P BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 CETYLPYRIDINIUM ACTIVE MOIETY CUB7JI0JV3 BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 ETHYL MENTHANE CARBOXAMIDE INACTIVE INGREDIENT 6S7S02945H BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 MYRRH OIL INACTIVE INGREDIENT H74221J5J4 BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 POLYOXYL 40 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 7YC686GQ8F BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 TEA TREE OIL INACTIVE INGREDIENT VIF565UC2G BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2 ZINC CITRATE INACTIVE INGREDIENT K72I3DEX9B BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-294 BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.] 6 Legacy NDC, 2 package rows 20230131_37b2c031-ecc9-4420-9d84-e71c0e529187.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54473-294-08 54473029408 237 mL in 1 BOTTLE (54473-294-08) 237 ml 2018-01-01 0000-00-00 No No Current