Mucinex Fast-Max

Product NDC: 63824-591
11-digit product format: 638240591
Labeler code: 63824
Product ID: 63824-591_51b46950-2d62-8fbc-e063-6294a90a76e6
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: 2015-07-15
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63824-591-16	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63824-591-16	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1
GUAIFENESIN	200 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1656815	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a3523aa3-9ed1-472d-9986-438440d0a3eb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63824-591-16	2022-08-08	C162847	48780-1	d6a99b39-50ad-a426-e053-dadaa90af4c2	Mucinex® Fast-Max ® Cold, Flu & Sore Throat
63824-591-16	2022-01-28	C162847	48780-1	d6a99b39-50ad-a426-e053-dadaa90af4c2	Mucinex® Fast-Max ® Cold, Flu & Sore Throat

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63824-591-16	Mucinex Fast-MaxCold, Flu and Sore Throat	8 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	8		10
63824-591-16	Mucinex Fast-MaxCold, Flu and Sore Throat	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-591-16	EA - Each	63824-591	fc2e079d-bbcc-4aa8-b185-34673df99f50	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
Dextromethorphan hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
Guaifenesin	ACTIVE MOIETY	495W7451VQ	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
gelatin	INACTIVE INGREDIENT	2G86QN327L	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
lecithin, soybean	INACTIVE INGREDIENT	1DI56QDM62	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
povidones	INACTIVE INGREDIENT	FZ989GH94E	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
sorbitol	INACTIVE INGREDIENT	506T60A25R	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2
water	INACTIVE INGREDIENT	059QF0KO0R	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63824-591	MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RB HEALTH (US) LLC]	9	Current NDC, Legacy NDC, 2 package rows	20241222_a3523aa3-9ed1-472d-9986-438440d0a3eb.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vicks childrens Cough Congestion	PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN	The Procter & Gamble Manufacturing Company	e2356457-9791-3710-e053-2995a90ad140	2026-09-08	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	077fac1a-0ec5-40d9-8861-a281b48f650a	2026-09-08	Warnings	Exact identifier application number: M012
Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	RARITAN PHARMACEUTICALS	eef00453-9f4f-4a05-bb4e-49b94705b52c	2026-09-08	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	RARITAN PHARMACEUTICALS INC	9819155b-2713-42be-867e-16605e7643d0	2026-09-08	Warnings	Exact identifier application number: M012
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	WALMART INC.	f9d1dfd1-527f-491d-9188-14886ac70ced	2026-09-08	Warnings	Exact identifier application number: M012
severe cold and cough daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	RARITAN PHARMACEUTICALS INC	3ce8508e-7d9d-4413-858a-8f952e760c01	2026-09-08	Warnings	Exact identifier application number: M012
Multi Symptom Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	RARITAN PHARMACEUTICALS INC	d9606c9a-31b1-4121-9870-809a05f5b68a	2026-09-08	Warnings	Exact identifier application number: M012
Mucus Relief DM Honey and Berry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	RARITAN PHARMACEUTICALS INC	4898b1c2-55ef-4589-982b-2279c01707e5	2026-09-08	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Chain Drug Marketing Association, Inc.	2a7afe03-3c34-4e30-827e-b3bb2568cb97	2026-09-08	Warnings	Exact identifier application number: M012
Drx Choice childrens allergy chews	DIPHENHYDRAMINE HCL	RARITAN PHARMACEUTICALS INC	dd2be906-bd0a-437c-9693-54b9391a5da3	2026-09-05	Warnings	Exact identifier application number: M012
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	49235f4f-e661-4a83-88ef-b9a956848777	2026-09-04	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	71845bf9-8981-4ca0-a62c-dbef102b1b02	2026-09-04	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	774d2bde-9f57-4ced-800a-cada39c685ed	2026-09-04	Warnings	Exact identifier application number: M012
Nostrilla	OXYMETAZOLINE HYDROCHLORIDE	Insight Pharmaceuticals LLC	86217847-8e2b-48cc-b289-4987fd3aa7c3	2026-09-04	Warnings	Exact identifier application number: M012
tussin cough chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Rite Aid Corporation	86fc3723-5fc5-4de5-bd04-7774c2abe539	2026-09-04	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Topco Associates, LLC	ed576bf1-3949-423e-af2e-e4b1a3839b21	2026-09-04	Warnings	Exact identifier application number: M012
tussin nighttime cough	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Rite Aid Corporation	80d51af8-3a7b-4d22-8d4f-df5f91913047	2026-09-04	Warnings	Exact identifier application number: M012
NO MORE NOSEBLEED	OXYMETAZOLINE HYDROCHLORIDE	DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.	69d3f1fe-b476-4f84-8c5e-94957b74b46c	2026-09-04	Warnings	Exact identifier application number: M012
Ultra Fine Mist Sinus Relief	OXYMETAZOLINE HYDROCHLORIDE	DOLGENCORP, INC.	5f134840-2465-4585-a85d-08d746f76f7a	2026-09-03	Warnings	Exact identifier application number: M012
Daytime Nighttime Severe Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATE	Family Dollar (FAMILY WELLNESS)	22918db6-9096-4eb8-a742-aaa2dd5c31da	2026-09-03	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1656815	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	a3523aa3-9ed1-472d-9986-438440d0a3eb	10
1656815	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	a3523aa3-9ed1-472d-9986-438440d0a3eb	10
1656815	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule	SY	a3523aa3-9ed1-472d-9986-438440d0a3eb	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63824-591-16	63824059116	2 BLISTER PACK in 1 CARTON (63824-591-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2015-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mucinex® Fast-Max ® Cold, Flu & Sore Throat	Reckitt Benckiser LLC	2026-05-13	HUMAN OTC DRUG LABEL	10