Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain

Product NDC: 63824-266
11-digit product format: 638240266
Labeler code: 63824
Product ID: 63824-266_5dcc75a5-5a70-a8e1-e063-6394a90a8050
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Reckitt Benckiser LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-03-01
Substance: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 650; 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/20mL
GUAIFENESIN	400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE	10 mg/20mL

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
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
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
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
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
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-02-11	Maximum Strength Mucinex® Sinus-Max® Severe Congestion and Pain
2020-02-11	Maximum Strength Mucinex® Sinus-Max® Severe Congestion and Pain
2020-01-31	Maximum Strength Mucinex® Sinus-Max® Severe Congestion and Pain
2020-01-31	Maximum Strength Mucinex® Sinus-Max® Severe Congestion and Pain

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63824-266-66	Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain	180 mL in 1 BOTTLE	SOLUTION	180		7
63824-266-66	Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain and Mucinex Nightshift Sinus	180 mL in 1 BOTTLE	SOLUTION	180 mL	650 mg in 20mL	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63824-266	MAXIMUM STRENGTH MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RB HEALTH (US) LLC]	6	Current NDC, Legacy NDC, 1 package rows	20241220_cea08797-1d53-4434-be1a-144f2ded5f9d.zip
63824-266	MAXIMUM STRENGTH MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN AND MUCINEX NIGHTSHIFT SINUS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC]	3	Current NDC, Legacy NDC	20241220_75c6b92f-219f-4740-bb72-c02a927a21ff.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 28 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Childrens Stuffy Nose and Chest Congestion	GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	7354f57c-0ecf-481f-9482-0040c90c4350	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	5bda415d-739f-4ca5-b5b2-07c14a81863b	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8f3eb5c5-832e-4806-b3da-ef112cf55dcf	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDE	Reckitt Benckiser LLC	e3aea6df-37a4-43c5-a192-a902cbff3f92	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d9e5a8d7-814c-4ab1-bb05-e4cb9155978e	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack	ACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	Reckitt Benckiser LLC	c7ab5201-8550-4bf4-957c-c8f049aeaa4a	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	84e7be8f-2785-45ef-9c44-de05394fcd99	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	771d7fd8-184f-48a3-90ed-e8f00159d97e	2026-05-18	Warnings	Exact identifier application number: M012
MUCINEX Childrens Stuffy Nose	OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	de1c0abd-1644-4351-8106-e9df6ca5c142	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Fever Sore Throat and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	1538a75d-582a-9501-e063-6394a90a6c55	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	19105007-0193-0764-e063-6294a90a01a4	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and Flu	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN,TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	34fd2458-9acd-cdf7-e063-6394a90a3d0a	2026-05-18	Warnings	Exact identifier application number: M012
MUCINEX FAST-MAX NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3a24b06c-00a6-c2ef-e063-6294a90a4d72	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	14be3ab0-d6ae-e342-e063-6294a90ab851	2026-05-18	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Bryant Ranch Prepack	20f00537-2c8a-45d1-8e5f-ec276d0a47b6	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	38df2308-f6f9-4476-ad34-4b5bc5f9fdf2	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Plus Headache Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALMART INC.	88e3b969-79d0-4e64-95c0-c5cfd41e365f	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	db264d2f-bf81-4da2-8595-2bfa1e4ba2f1	2026-05-18	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c	2026-05-15	Warnings	Exact identifier application number: M012
good neighbor pharmacy cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	da91e6b6-32ff-44fd-afce-33ea9549554b	2026-05-15	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
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
1116568	acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution	PSN	cea08797-1d53-4434-be1a-144f2ded5f9d	7
1116568	acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	cea08797-1d53-4434-be1a-144f2ded5f9d	7
1116568	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	cea08797-1d53-4434-be1a-144f2ded5f9d	7
1116568	acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	cea08797-1d53-4434-be1a-144f2ded5f9d	7
1116568	APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution	SY	cea08797-1d53-4434-be1a-144f2ded5f9d	7
1116568	APAP 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	cea08797-1d53-4434-be1a-144f2ded5f9d	7
2397132	{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack	GPCK	75c6b92f-219f-4740-bb72-c02a927a21ff	4
2397132	1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) / 1 daytime (acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution) Pack	PSN	75c6b92f-219f-4740-bb72-c02a927a21ff	4
2173662	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution	PSN	75c6b92f-219f-4740-bb72-c02a927a21ff	4
1116568	acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution	PSN	75c6b92f-219f-4740-bb72-c02a927a21ff	4
2173662	acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution	SCD	75c6b92f-219f-4740-bb72-c02a927a21ff	4
1116568	acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	75c6b92f-219f-4740-bb72-c02a927a21ff	4
2397132	1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) / 1 daytime (acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution) Pack	SY	75c6b92f-219f-4740-bb72-c02a927a21ff	4
2173662	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG per 10 mL Oral Solution	SY	75c6b92f-219f-4740-bb72-c02a927a21ff	4
1116568	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	75c6b92f-219f-4740-bb72-c02a927a21ff	4
2173662	acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution	SY	75c6b92f-219f-4740-bb72-c02a927a21ff	4
1116568	acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	75c6b92f-219f-4740-bb72-c02a927a21ff	4
2173662	APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution	SY	75c6b92f-219f-4740-bb72-c02a927a21ff	4
1116568	APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution	SY	75c6b92f-219f-4740-bb72-c02a927a21ff	4
1116568	APAP 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	75c6b92f-219f-4740-bb72-c02a927a21ff	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63824-266-66	63824026666	180 mL in 1 BOTTLE (63824-266-66)	180 ml	2018-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain	Reckitt Benckiser LLC	2026-10-18	HUMAN OTC DRUG LABEL	5
Maximum Strength Mucinex® Sinus-Max® Severe Congestion and Pain	Reckitt Benckiser LLC	2026-10-14	HUMAN OTC DRUG LABEL	8