Home NDC 63824-791 Mucinex Fast-Max
Product NDC 63824-791
11-digit product format 638240791
Labeler code 63824
Product ID 63824-791_e778c133-746e-449e-ac80-5bbc458d8f48
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form TABLET, FILM 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; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 · 2 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 product product 63824-791 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63824-791 63824-791-01 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 63824-791 MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [RB HEALTH (US) LLC] 4 Legacy NDC 20230927_7f6f8a9d-e5da-4be5-b5e2-eb6c5241d227.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63824-791-01 63824079101 2 BLISTER PACK in 1 CARTON (63824-791-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2018-08-01 0000-00-00 No No Current