CounterAct

Product NDC
54473-080
11-digit product format
544730080
Labeler code
54473
Product ID
54473-080_5e625e37-7a05-469e-88f4-b66404c78d26
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr. and Guaifenesin
Dosage form
SYRUP
Route
ORAL
Labeler
Melaleuca, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-08-28
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 mg/5mL; mg/5mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-080-042025-12-04C16284748780-19d75b9d1-2451-f424-e053-dadaa90a57ce09c5b6d1-5ddf-419f-86d8-4e1c371b99c8
54473-080-042020-01-31C16284748780-19d75b9d1-2451-f424-e053-dadaa90a57ce09c5b6d1-5ddf-419f-86d8-4e1c371b99c8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUNTERACT COUGH (DEXTROMETHORPHAN HBR. AND GUAIFENESIN) SYRUP [MELALEUCA, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCOUNTERACT COUGH (DEXTROMETHORPHAN HBR. AND GUAIFENESIN) SYRUP [MELALEUCA, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUNTERACT COUGH (DEXTROMETHORPHAN HBR. AND GUAIFENESIN) SYRUP [MELALEUCA, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQCOUNTERACT COUGH (DEXTROMETHORPHAN HBR. AND GUAIFENESIN) SYRUP [MELALEUCA, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCOUNTERACT COUGH (DEXTROMETHORPHAN HBR. AND GUAIFENESIN) SYRUP [MELALEUCA, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOUNTERACT COUGH (DEXTROMETHORPHAN HBR. AND GUAIFENESIN) SYRUP [MELALEUCA, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOUNTERACT COUGH (DEXTROMETHORPHAN HBR. AND GUAIFENESIN) SYRUP [MELALEUCA, INC.]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCOUNTERACT COUGH (DEXTROMETHORPHAN HBR. AND GUAIFENESIN) SYRUP [MELALEUCA, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COUNTERACT COUGH (DEXTROMETHORPHAN HBR. AND GUAIFENESIN) SYRUP [MELALEUCA, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOUNTERACT COUGH (DEXTROMETHORPHAN HBR. AND GUAIFENESIN) SYRUP [MELALEUCA, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOUNTERACT COUGH (DEXTROMETHORPHAN HBR. AND GUAIFENESIN) SYRUP [MELALEUCA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCOUNTERACT COUGH (DEXTROMETHORPHAN HBR. AND GUAIFENESIN) SYRUP [MELALEUCA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-080COUNTERACT COUGH (DEXTROMETHORPHAN HBR. AND GUAIFENESIN) SYRUP [MELALEUCA, INC.]1Legacy NDC20110321_09c5b6d1-5ddf-419f-86d8-4e1c371b99c8.zip