Mucus Relief

Product NDC
41520-037
11-digit product format
415200037
Labeler code
41520
Product ID
41520-037_7c54acfe-c56c-4b73-b827-5ba66dfbbe0c
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Care One (American Sales Company)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-10-31
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20 mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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 productproduct41520-037DDiscontinued by firm2026-10-05
excluded packagepackage41520-03741520-037-06DDiscontinued by firm2026-10-05

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 INGREDIENT9D2RTI9KYHMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
GUAIFENESINACTIVE MOIETY495W7451VQMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92MUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
SORBITOLINACTIVE INGREDIENT506T60A25RMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4MUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
WATERINACTIVE INGREDIENT059QF0KO0RMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-037MUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]7Legacy NDC20241011_236ea84d-c09e-4fed-8be4-512dc634a72f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-037-0641520003706177 mL in 1 BOTTLE, PLASTIC (41520-037-06) 177 ml2014-10-310000-00-00NoNoCurrent