FDA.reportPublic FDA data

MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX

Product NDC
53943-517
11-digit product format
539430517
Labeler code
53943
Product ID
53943-517_4655e03d-388e-39d8-e063-6294a90aef8f
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Discount Drug Mart
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-12-10
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20; 400; 10 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1043543

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-517-252022-12-18C16284748780-19d75b9d0-cc25-f424-e053-dadaa90a57cef17385bc-82bb-4183-a4c9-067d8afb3757
53943-517-252022-01-28C16284748780-19d75b9d0-cc25-f424-e053-dadaa90a57cef17385bc-82bb-4183-a4c9-067d8afb3757
53943-517-252020-12-31C16284748780-19d75b9d0-cc25-f424-e053-dadaa90a57cef17385bc-82bb-4183-a4c9-067d8afb3757
53943-517-252020-01-31C16284748780-19d75b9d0-cc25-f424-e053-dadaa90a57cef17385bc-82bb-4183-a4c9-067d8afb3757

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-517-25MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX177 mL in 1 BOTTLELIQUID1777

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
GUAIFENESINACTIVE INGREDIENT495W7451VQMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
GUAIFENESINACTIVE MOIETY495W7451VQMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92MAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
SORBITOLINACTIVE INGREDIENT506T60A25RMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4MAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
WATERINACTIVE INGREDIENT059QF0KO0RMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-517MAXIUM STRENGTH SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]6Current NDC, Legacy NDC, 1 package rows20241225_f17385bc-82bb-4183-a4c9-067d8afb3757.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNf17385bc-82bb-4183-a4c9-067d8afb37577
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDf17385bc-82bb-4183-a4c9-067d8afb37577
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYf17385bc-82bb-4183-a4c9-067d8afb37577
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYf17385bc-82bb-4183-a4c9-067d8afb37577

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-517-2553943051725177 mL in 1 BOTTLE (53943-517-25) 177 ml2013-12-102023-12-31NoNoCurrent