Maximum Strength Mucinex Fast-Max Cold and Flu

Product NDC
63824-518
11-digit product format
638240518
Labeler code
63824
Product ID
63824-518_51a452ea-cabe-dbe7-e063-6294a90ac838
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-28
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
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
Maximum Strength Mucinex Fast-Max Cold and Flu
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1656815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-518-08Maximum Strength Mucinex Fast-Max Cold and Flu8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED86
63824-518-08Maximum Strength Mucinex Fast-Max Cold and Flu1 in 1 CARTONCAPSULE, LIQUID FILLED16
63824-518-16Maximum Strength Mucinex Fast-Max Cold and Flu8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED86
63824-518-16Maximum Strength Mucinex Fast-Max Cold and Flu2 in 1 CARTONCAPSULE, LIQUID FILLED26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-518-16EA - Each63824-518a48c4a0b-f2f4-4f6b-b32b-b49a0ad3038e12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-518MAXIMUM STRENGTH MUCINEX FAST-MAX COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RB HEALTH (US) LLC]5Current NDC, Legacy NDC, 4 package rows20241220_fe7eeb71-e219-4c84-ac06-98c3a40b14dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSNfe7eeb71-e219-4c84-ac06-98c3a40b14dc6
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDfe7eeb71-e219-4c84-ac06-98c3a40b14dc6
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYfe7eeb71-e219-4c84-ac06-98c3a40b14dc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-518-08638240518081 BLISTER PACK in 1 CARTON (63824-518-08) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2020-06-010000-00-00NoNoCurrent
63824-518-16638240518162 BLISTER PACK in 1 CARTON (63824-518-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2018-07-280000-00-00NoNoCurrent