FDA.reportPublic FDA data

Mucinex Fast-Max

Product NDC
63824-193
11-digit product format
638240193
Labeler code
63824
Product ID
63824-193_51a49920-1f2b-2b23-e063-6294a90ace67
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-15
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10; 200; 5 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
Mucinex Fast-Max
Brand name suffix
Severe Congestion and Cough
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1372652

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-193-20Mucinex Fast-MaxSevere Congestion and Cough10 in 1 BLISTER PACKTABLET, COATED1012
63824-193-20Mucinex Fast-MaxSevere Congestion and Cough2 in 1 CARTONTABLET, COATED212
63824-193-21Mucinex Fast-MaxSevere Congestion and Cough2 in 1 CARTONTABLET, COATED212
63824-193-21Mucinex Fast-MaxSevere Congestion and Cough10 in 1 BLISTER PACKTABLET, COATED1012
63824-193-30Mucinex Fast-MaxSevere Congestion and Cough3 in 1 CARTONTABLET, COATED312
63824-193-30Mucinex Fast-MaxSevere Congestion and Cough10 in 1 BLISTER PACKTABLET, COATED1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-193-20EA - Each63824-193ce7e2c2e-b0c4-44d2-9cf8-7f3b1991e1c312013-11-04
63824-193-30EA - Each63824-193f55e9eef-3a6b-42c7-9cfe-b7dd61da2d6212014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYHMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
GuaifenesinACTIVE INGREDIENT495W7451VQMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
DextromethorphanACTIVE MOIETY7355X3ROTSMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
GuaifenesinACTIVE MOIETY495W7451VQMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
PhenylephrineACTIVE MOIETY1WS297W6MVMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
aluminum oxideINACTIVE INGREDIENTLMI26O6933MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQKMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOAMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
micaINACTIVE INGREDIENTV8A1AW0880MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
polyvinyl alcoholINACTIVE INGREDIENT532B59J990MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
povidone K29/32INACTIVE INGREDIENT390RMW2PEQMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
talcINACTIVE INGREDIENT7SEV7J4R1UMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-193MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RB HEALTH (US) LLC]11Current NDC, Legacy NDC, 6 package rows20241222_3ff4c4ea-7628-4d2b-a6e9-d994c25baef4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372652dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN3ff4c4ea-7628-4d2b-a6e9-d994c25baef412
1372652dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD3ff4c4ea-7628-4d2b-a6e9-d994c25baef412
1372652dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral TabletSY3ff4c4ea-7628-4d2b-a6e9-d994c25baef412
2560238{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral Tablet) / 1 (dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } PackGPCKa401eb92-60b6-427d-a677-29371a3150be4
25602381 daytime (dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral Tablet) PackPSNa401eb92-60b6-427d-a677-29371a3150be4
2549034acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral TabletPSNa401eb92-60b6-427d-a677-29371a3150be4
1372652dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNa401eb92-60b6-427d-a677-29371a3150be4
2549034acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral TabletSCDa401eb92-60b6-427d-a677-29371a3150be4
1372652dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDa401eb92-60b6-427d-a677-29371a3150be4
25602381 daytime (dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral Tablet) PackSYa401eb92-60b6-427d-a677-29371a3150be4
2549034APAP 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral TabletSYa401eb92-60b6-427d-a677-29371a3150be4
1372652dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral TabletSYa401eb92-60b6-427d-a677-29371a3150be4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-193-20638240193202 BLISTER PACK in 1 CARTON (63824-193-20) > 10 TABLET, COATED in 1 BLISTER PACK2 blister pack2013-03-150000-00-00NoNoCurrent
63824-193-21638240193212 BLISTER PACK in 1 CARTON (63824-193-21) / 10 TABLET, COATED in 1 BLISTER PACK2 blister pack2020-10-010000-00-00NoNoCurrent
63824-193-30638240193303 BLISTER PACK in 1 CARTON (63824-193-30) > 10 TABLET, COATED in 1 BLISTER PACK3 blister pack2013-03-150000-00-00NoNoCurrent