FDA.reportPublic FDA data

Mucinex Fast-Max

Product NDC
63824-015
11-digit product format
638240015
Labeler code
63824
Product ID
63824-015_51a49739-9f9d-ccd7-e063-6394a90a1003
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-07
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 20; 400; 10 mg/20mL; 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucinex Fast-Max
Brand name suffix
Cold, Flu and Sore Throat
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1116572

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-015-66Mucinex Fast-MaxCold, Flu and Sore Throat180 mL in 1 BOTTLESOLUTION18012
63824-015-69Mucinex Fast-MaxCold, Flu and Sore Throat266 mL in 1 BOTTLESOLUTION26612

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-015-66ML - Milliliter63824-0159e1d0fea-96e4-4abe-be6b-7a79cd90af7e12012-07-24
63824-015-69ML - Milliliter63824-01543719413-5127-43ea-a198-470846792c6912013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
acetaminophenACTIVE INGREDIENT362O9ITL9DMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYHMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
guaifenesinACTIVE INGREDIENT495W7451VQMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
acetaminophenACTIVE MOIETY362O9ITL9DMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
dextromethorphanACTIVE MOIETY7355X3ROTSMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
guaifenesinACTIVE MOIETY495W7451VQMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
phenylephrineACTIVE MOIETY1WS297W6MVMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
edetate disodiumINACTIVE INGREDIENT7FLD91C86KMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
FD&C Blue NO. 1INACTIVE INGREDIENTH3R47K3TBDMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
FD&C Red NO. 40INACTIVE INGREDIENTWZB9127XOAMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
glycerinINACTIVE INGREDIENTPDC6A3C0OXMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
propyl gallateINACTIVE INGREDIENT8D4SNN7V92MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
sorbitolINACTIVE INGREDIENT506T60A25RMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
waterINACTIVE INGREDIENT059QF0KO0RMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4
xanthan gumINACTIVE INGREDIENTTTV12P4NEEMUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-015MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RB HEALTH (US) LLC]10Current NDC, Legacy NDC, 2 package rows20241222_c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSNc902b4fc-c71c-4ef2-b5cb-6c2bd019acbc12
1116572acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDc902b4fc-c71c-4ef2-b5cb-6c2bd019acbc12
1116572acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYc902b4fc-c71c-4ef2-b5cb-6c2bd019acbc12
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSYc902b4fc-c71c-4ef2-b5cb-6c2bd019acbc12
1116572APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSYc902b4fc-c71c-4ef2-b5cb-6c2bd019acbc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-015-6663824001566180 mL in 1 BOTTLE (63824-015-66) 180 ml2012-02-070000-00-00NoNoCurrent
63824-015-6963824001569266 mL in 1 BOTTLE (63824-015-69) 266 ml2012-02-070000-00-00NoNoCurrent