Mucus Relief Severe Congestion and Cough

Product NDC: 36800-037
11-digit product format: 368000037
Labeler code: 36800
Product ID: 36800-037_1ae06753-b458-429f-906a-0c4ecb463efc
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: TOP CARE (Topco Associates LLC)
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-02-28
Marketing end: 2026-12-28
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 20; 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], 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
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: Mucus Relief Severe Congestion and Cough
Brand name suffix: Maximum Strength

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/20mL
GUAIFENESIN	400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE	10 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
1043543	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
98dd0ba6-0109-46b2-92df-11a030984240	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
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
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
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-037-06	Mucus Relief Severe Congestion and CoughMaximum Strength	177 mL in 1 BOTTLE, PLASTIC	LIQUID	177		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
PROPYL GALLATE	INACTIVE INGREDIENT	8D4SNN7V92	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-037	MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	6	Current NDC, Legacy NDC, 1 package rows	20231014_98dd0ba6-0109-46b2-92df-11a030984240.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 17 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flu HBP Maximum Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Rite Aid Corporation	f1a4ee57-33a3-4791-a769-b208b38acb72	2026-07-13	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY Childrens Allergy Relief	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	c499574c-f32b-4608-bf8b-51ad44e35725	2026-07-13	Warnings	Exact identifier application number: M012
Good NeighborChildrens Allergy Relief Bubblegum flavor	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	f442c61b-7d2c-401c-b862-acbe2282927b	2026-07-13	Warnings	Exact identifier application number: M012
Sanatos	MENTHOL	Pharmadel LLC	5683b099-f029-2d08-e063-6394a90ad482	2026-07-13	Warnings	Exact identifier application number: M012
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f673cdeb-4f8b-46b4-be92-c725d74abc55	2026-07-13	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	e4fca5ba-2d45-4c38-b0fd-297159d1705a	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	AMERISOURCE BERGEN	0269c0fd-0d8f-4264-9025-d4dcb3c45c60	2026-07-13	Warnings	Exact identifier application number: M012
Propolis Cooling Relief Cherry Cough Drops	MENTHOL, UNSPECIFIED FORM	Beekeeper's Naturals USA Inc	7087566d-f24a-4508-aa25-7f42d055c43e	2026-07-13	Warnings	Exact identifier application number: M012
Sinus Pressure and Congestion Relief	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Rite Aid Corporation	35bcf263-3296-4d9c-84c0-146a173d6e87	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Childrens Cough Relief Cherry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	AMERISOURCE BERGEN	a8e2fd43-b801-41ae-8d79-8ecf4a771543	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor No Drip Nasal Mist Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	AMERISOURCE BERGEN	7872aadd-b23c-431f-8048-24eece25ca2d	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	AMERISOURCE BERGEN	404a3521-8340-4476-a068-0e69cd0e514f	2026-07-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab5	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Long Acting Cough Adult Tussin	DEXTROMETHORPHAN HBR	AMERISOURCE BERGEN	df3c76bd-bd5b-42d7-a5f1-560fd3cba646	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Adult Tussin Mucus and chest congestion	GUAIFENESIN	AMERISOURCE BERGEN	97e9cd18-dd55-4a26-80e3-4c17b9e1a1e8	2026-07-13	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	AMERISOURCE BERGEN	a217ca8a-1c00-4816-bc26-cc0f71c80c90	2026-07-13	Warnings	Exact identifier application number: M012
Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	1ddc04fb-069c-44fe-814b-ba4f503c4be0	2026-07-10	Warnings	Exact identifier application number: M012
COUGH DROPS- menthol granule	MENTHOL GRANULE	Anhui Jiuhe Health Industry Co., Ltd	5351b943-5830-e4e7-e063-6394a90a5b66	2026-07-10	Warnings	Exact identifier application number: M012
ValuMeds Nasal Decongestant PE Phenylephrine	PHENYLEPHRINE HYDROCHLORIDE	Cabinet Health P.B.C.	3f284420-87c1-4c17-99e5-bc569bf9d45f	2026-07-10	Warnings	Exact identifier application number: M012
Severe Congestion and Cough Multi-Symptom Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS Pharmacy	707eb066-cdfc-444b-833a-9d6d133d48e4	2026-07-10	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
1043543	dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	98dd0ba6-0109-46b2-92df-11a030984240	7
1043543	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	98dd0ba6-0109-46b2-92df-11a030984240	7
1043543	dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	98dd0ba6-0109-46b2-92df-11a030984240	7
1043543	dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	98dd0ba6-0109-46b2-92df-11a030984240	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-037-06	36800003706	177 mL in 1 BOTTLE, PLASTIC (36800-037-06)	177 ml	2015-02-28	2026-12-28	No	No	Current