FDA.reportPublic FDA data

Tussin Cough and Chest Congestion DM

Product NDC
55301-385
11-digit product format
553010385
Labeler code
55301
Product ID
55301-385_d89b742b-4463-48a6-a3be-d71331f69d7e
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
2015-09-30
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/10mL; mg/10mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct55301-385DDiscontinued by firm2026-10-12
excluded packagepackage55301-38555301-385-08DDiscontinued by firm2026-10-12

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 productproduct55301-385DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55301-38555301-385-08DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55301-385-082023-05-09C16284748780-1f386c649-c0b3-0266-e053-dadaa90a7c1aDrug Facts
55301-385-082023-01-30C16284748780-1f386c649-c0b3-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
DEXTROSE, UNSPECIFIED FORMINACTIVE INGREDIENTIY9XDZ35W2TUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3ATUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-385TUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AAFES/YOUR MILITARY EXCHANGES]7Legacy NDC20250510_382efbca-0a45-4ece-b43d-6948dc7c4b4d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55301-385-08553010385081 BOTTLE, PLASTIC in 1 BOX (55301-385-08) > 237 mL in 1 BOTTLE, PLASTIC2015-09-300000-00-00NoNoCurrent