H E B MAX SEVERE CONGESTION and COUGH

Product NDC: 37808-317
11-digit product format: 378080317
Labeler code: 37808
Product ID: 37808-317_9f2c6806-1156-4c91-8581-68b7fcf039ec
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form: LIQUID
Route: ORAL
Labeler: H E B
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-09-14
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
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: H E B MAX SEVERE CONGESTION and COUGH
Brand name suffix: Maxium Strength
Listing expiration: 2027-12-31

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
d2b016ee-5329-45bf-9d71-d626204169cf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37808-317-25	H E B MAX SEVERE CONGESTION and COUGHMaxium Strength	177 mL in 1 BOTTLE	LIQUID	177		4

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-317	H E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]	4	Current NDC, Legacy NDC, 1 package rows	20231230_d2b016ee-5329-45bf-9d71-d626204169cf.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 37 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	50762d7c-5efd-4f83-e063-6294a90abf7f	2026-04-27	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	6427b418-89d1-4eac-b25b-0adfefc204fc	2026-04-27	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Care One (American Sales Company)	bd5de3b3-7cb5-4403-b664-23ac70b9957f	2026-04-27	Warnings	Exact identifier application number: M012
Leader Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. dba Leader	333c7042-95b8-4d98-9df1-4287017afa36	2026-04-25	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Sportpharm LLC	f2d55d1b-c3d4-4c35-b761-681ed50273bd	2026-04-24	Warnings	Exact identifier application number: M012
Geri-Dryl allergy relief	DIPHENHYDRAMINE HCL	Sportpharm LLC	2c4e0d5e-958d-4274-876a-52126c795c0f	2026-04-24	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	50364a42-3333-51fe-e063-6394a90ab71e	2026-04-24	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5036dc50-e95b-ea8d-e063-6394a90a6cfe	2026-04-24	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	dcb33d5f-87fa-4043-9b6d-36adec96796c	2026-04-24	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	Cardinal Health 107, LLC	abc0e348-8532-4658-bd8c-d7dbe5a28c7d	2026-04-23	Warnings	Exact identifier application number: M012
nitetime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Publix Super Markets Inc	c5535aaf-c029-48d8-97d1-105a49b5fd95	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer Healthcare LLC.	50228b3c-d54a-485d-e063-6394a90a4403	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Flu Severe Fast Chewables	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5025a333-6378-bf59-e063-6394a90af4f0	2026-04-23	Warnings	Exact identifier application number: M012
POLY-HIST DM	DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR	POLY PHARMACEUTICALS, INC.	5025c99f-b946-e2e0-e063-6394a90a13fb	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5026611c-93e7-8f90-e063-6394a90a7baa	2026-04-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	c9c1db0f-6ba4-433c-b0ce-e99e9351c0b0	2026-04-23	Warnings	Exact identifier application number: M012
Severe Cold and Flu Plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	COSTCO WHOLESALE CORPORATION	5180abbc-c6c4-4b82-b6e7-4504e3bcff0f	2026-04-23	Warnings	Exact identifier application number: M012
Severe Cold and Flu Night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	HyVee Inc	4f963491-e1f0-494d-acb6-5f4d2b267d4a	2026-04-22	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	f4b01827-7444-3bfc-e053-2a95a90aebed	2026-04-22	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH,	cfd43b8f-8064-6b88-e053-2a95a90a329e	2026-04-22	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	d2b016ee-5329-45bf-9d71-d626204169cf	4
1043543	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	d2b016ee-5329-45bf-9d71-d626204169cf	4
1043543	dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	d2b016ee-5329-45bf-9d71-d626204169cf	4
1043543	dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	d2b016ee-5329-45bf-9d71-d626204169cf	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-317-25	37808031725	177 mL in 1 BOTTLE (37808-317-25)	177 ml	2012-09-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXTROMETHORPHAN HYDROBROMIDE - H E B \| AptaPharma Inc.	H E B \| AptaPharma Inc.	2023-12-29	HUMAN OTC DRUG LABEL	4