Mucus Relief DM

Product NDC
69517-120
11-digit product format
695170120
Labeler code
69517
Product ID
69517-120_eec75c63-bdcd-aaad-e053-2995a90a8d07
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr Tablets
Dosage form
TABLET
Route
ORAL
Labeler
Healthlife of USA LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-05-31
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
15 mg/1; mg/1
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69517-120DDiscontinued by firm2026-10-05
excluded packagepackage69517-12069517-120-12DDiscontinued by firm2026-10-05

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct69517-120DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69517-12069517-120-12DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…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
NDCDashboard titleSPL versionValidationDashboard ZIP
69517-120MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR TABLETS) TABLET [HEALTHLIFE OF USA LLC]6Legacy NDC20231021_53d4d306-3175-49e3-8c30-eae71a332f09.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69517-120-12695170120121 BOTTLE in 1 CARTON (69517-120-12) > 12 TABLET in 1 BOTTLE1 bottle2017-05-310000-00-00NoNoCurrent