Tussin Cough and Chest Congestion DM

Product NDC
55319-385
11-digit product format
553190385
Labeler code
55319
Product ID
55319-385_13b0f8c9-5bee-408e-8d55-822413fc2066
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-02-28
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 productproduct55319-385DDiscontinued by firm2026-10-16
excluded packagepackage55319-38555319-385-08DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-385TUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]6Legacy NDC20230131_691f5813-10bb-461c-b565-d6564dc9820d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55319-385-08553190385081 BOTTLE, PLASTIC in 1 BOX (55319-385-08) > 237 mL in 1 BOTTLE, PLASTIC2015-02-280000-00-00NoNoCurrent