Home NDC 11822-7224-6 Mucus Relief DM
Product NDC 11822-7224
Requested package NDC 11822-7224-6
11-digit product format 118227224
Labeler code 11822
Product ID 11822-7224_cab798c2-9876-4926-818a-2be006d77786
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Rite Aid Corporation
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2021-11-26
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20 mg/20mL; mg/20mL
Pharmacologic classes 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]
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 · 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 11822-7224 11822-7224-6 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 11822-7224 11822-7224-6 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 11822-7224 11822-7224-6 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11822-7224 MUCUS RELIEF DM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [RITE AID CORPORATION] 4 Legacy NDC 20240509_552c942a-ae19-4e48-8bb7-198cd4e24a12.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11822-7224-6 11822722406 117 mL in 1 BOTTLE (11822-7224-6) 117 ml 2021-11-26 0000-00-00 No No Current