Home NDC 63824-517-01 Mucinex Fast-Max
Product NDC 63824-517
Requested package NDC 63824-517-01
11-digit product format 638240517
Labeler code 63824
Product ID 63824-517_ab6260bb-4d5b-43e0-ab87-38b19a1a68d8
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide
Dosage form TABLET, COATED
Route ORAL
Labeler RB Health (US) LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2018-08-01
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63824-517 63824-517-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-517 MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED [RB HEALTH (US) LLC] 4 Legacy NDC 20231003_492b48ce-2d03-45b4-9af6-c3dd315b74f8.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63824-517-01 63824051701 2 BLISTER PACK in 1 CARTON (63824-517-01) > 10 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2018-08-01 0000-00-00 No No Current