Adult Tussin Cough and Chest Congestion DM

Product NDC
55301-817
11-digit product format
553010817
Labeler code
55301
Product ID
55301-817_7224ef2d-b906-43c7-8d27-5c19a94f28a0
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
AAFES/Your Military Exchanges
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-12-31
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/10mL; mg/10mL
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 productproduct55301-817DDiscontinued by firm2026-10-15
excluded packagepackage55301-81755301-817-04DDiscontinued by firm2026-10-15

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
55301-817ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]5Legacy NDC20250510_447deb85-fb65-4242-87f1-6e1477b84690.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55301-817-04553010817041 BOTTLE, PLASTIC in 1 BOX (55301-817-04) > 118 mL in 1 BOTTLE, PLASTIC2018-12-310000-00-00NoNoCurrent