Home NDC 63824-558-40 Mucinex Fast-Max Day Time Severe Congestion and Cough - Mucinex Fast-Max Night Time Cold and Flu
Product NDC 63824-558
Requested package NDC 63824-558-40
11-digit product format 638240558
Labeler code 63824
Product ID 63824-558_32b4f741-b546-4ac6-984f-fb0506ceda31
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form KIT
Labeler RB Health (US) LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2020-06-01
Marketing end 0000-00-00
Active strength 0
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 · 3 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 2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 63824-558 63824-558-40 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 63824-558 63824-558-40 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 63824-558 63824-558-40 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-558 MUCINEX FAST-MAX DAY TIME SEVERE CONGESTION AND COUGH - MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC] 3 Legacy NDC 20231003_498e597c-b372-4c3a-940e-e51a932fb31c.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63824-558-40 63824055840 4 KIT in 1 CARTON (63824-558-40) > 1 KIT in 1 KIT * 6 TABLET, COATED in 1 BLISTER PACK * 4 TABLET, COATED in 1 BLISTER PACK 4 kit 2020-06-01 0000-00-00 No No Current