MAX Cold, Flu, and Sore Throat

Product NDC: 37808-316
11-digit product format: 378080316
Labeler code: 37808
Product ID: 37808-316_0d19111b-d15e-4e5d-a9e1-5403e7509902
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL
Dosage form: LIQUID
Route: ORAL
Labeler: H E B
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-03-05
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 650; 20; 400; 10 mg/20mL; 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: MAX Cold, Flu, and Sore Throat
Listing expiration: 2027-12-31

Active Ingredients#

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

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
1116572	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
9b09b660-0758-48dc-84c9-26cdd2aacc03	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
37808-316-25	MAX Cold, Flu, and Sore Throat	117 mL in 1 BOTTLE	LIQUID	117		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
PROPYL GALLATE	INACTIVE INGREDIENT	8D4SNN7V92	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-316	MAX COLD, FLU, AND SORE THROAT (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL) LIQUID [H E B]	3	Current NDC, Legacy NDC, 1 package rows	20231230_9b09b660-0758-48dc-84c9-26cdd2aacc03.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 30 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bayer Rapid Relief	ASPIRIN/CAFFEINE ORAL POWDER	Bayer HealthCare LLC.	f1fecbb0-5b55-fe8f-e053-2995a90a0977	2025-12-05	Warnings	Exact identifier application number: M013
Headache Relief, Extra Strength 24/7 Life by 7-Eleven	ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATED	Lil' Drug Store Products, Inc.	45381b1c-2acd-1524-e063-6394a90a83d9	2025-12-05	Warnings	Exact identifier application number: M013
Acetaminophen Easy Tabs Extra Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	729132cd-f209-447a-8949-a90b5a5c01da	2025-12-05	Warnings	Exact identifier application number: M013
Menstrual Pain Relief Complete	ACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINE	Shield Pharmaceuticals Corp	05fda811-d65f-41b2-89e4-297cdddb3d99	2025-12-05	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	Health Pharma USA, LLC	3165b0a3-556b-6abe-e063-6394a90a7682	2025-12-04	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	ASPIRIN	Bayer HealthCare LLC.	44a08904-68b9-4d06-a28d-21aae3d6140c	2025-12-04	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	7a29dde6-a177-6206-e053-2991aa0a01f2	2025-12-04	Warnings	Exact identifier application number: M013
Extra Strength Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	7570aaa2-3238-4cd3-b788-915caa970dba	2025-12-04	Warnings	Exact identifier application number: M013
Bayer Headache	ASPIRIN AND CAFFEINE	Bayer HealthCare LLC.	c0a92873-0914-6a86-e053-2995a90ac41c	2025-12-04	Warnings	Exact identifier application number: M013
Alka-Seltzer Original Flavor	ALKA-SELTZER ORIGINAL FLAVOR	Bayer HealthCare LLC.	07478020-5ba0-3b67-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M013
Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	0dba1329-5b0d-5688-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M013
Alka-Seltzer Plus Cold Medicine Sparkling Original	ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	78537dcf-b157-4b67-a8b2-5cb144815166	2025-12-04	Warnings	Exact identifier application number: M013
BAYER Aspirin Extra Strength Caplets	BAYER ASPIRIN EXTRA STRENGTH	Bayer HealthCare LLC.	0ae64cdb-4ea0-23af-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M013
Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry Flavored	ASPIRIN	Bayer HealthCare LLC.	070d5713-e018-2913-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M013
Bayer Low Dose	ASPIRIN	Bayer HealthCare LLC.	075b103e-0bb4-4b7a-ac0e-5645bcbd0a07	2025-12-04	Warnings	Exact identifier application number: M013
Alka-Seltzer Original	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Bayer HealthCare LLC.	5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc	2025-12-04	Warnings	Exact identifier application number: M013
Bayer Aspirin Regimen enteric coated	ASPIRIN	Bayer HealthCare LLC.	0c6ae05f-7634-34d1-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M013
aspirin pain relief	ASPIRIN	Rite Aid Corporation	ae9d9977-7576-4894-8a32-454828abec9a	2025-12-04	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	RMT HEALTH LLC	2bacffd1-4870-73af-e063-6294a90a19c8	2025-12-02	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Rite Aid Corporation	d9caee45-be43-45ec-927f-e7fec5c14f07	2025-12-02	Warnings	Exact identifier application number: M013

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
1116572	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution	PSN	9b09b660-0758-48dc-84c9-26cdd2aacc03	3
1116572	acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	9b09b660-0758-48dc-84c9-26cdd2aacc03	3
1116572	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	9b09b660-0758-48dc-84c9-26cdd2aacc03	3
1116572	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution	SY	9b09b660-0758-48dc-84c9-26cdd2aacc03	3
1116572	APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution	SY	9b09b660-0758-48dc-84c9-26cdd2aacc03	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-316-25	37808031625	117 mL in 1 BOTTLE (37808-316-25)	117 ml	2014-03-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MAX Cold, Flu, and Sore Throat - H E B \| AptaPharma Inc.	H E B \| AptaPharma Inc.	2023-12-29	HUMAN OTC DRUG LABEL	3