Home NDC 37808-316 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.
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.
DailyMed Product Concepts# 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 Uploaded 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 26 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc f818417e-0b31-4fe7-8313-4160a00b248a 2025-12-22 Warnings Exact identifier application number: M013 CareALL Acetaminophen ACETAMINOPHEN New World Imports, Inc c4f82ed8-b82c-47bb-9ab9-108a13d29cf7 2025-12-22 Warnings Exact identifier application number: M013 CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc 5103450a-3095-49cc-9823-4fb4c1d258ff 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Non-Aspirin PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc 499b2bf8-72fb-4500-b16e-517cab09a8ae 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc 933154b9-c9d6-4260-8775-1c83631c74e4 2025-12-22 Warnings Exact identifier application number: M013 CAREALL Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL New World Imports, Inc c93aa5e4-3994-439f-8f14-4e81773ed4e2 2025-12-22 Warnings Exact identifier application number: M013 Acetaminophen Diphenhydramine HCl ACETAMINOPHEN DIPHENHYDRAMINE HCL Granules USA, Inc. 8c9f68e3-fedc-6457-e053-2995a90a045a 2025-12-22 Warnings Exact identifier application number: M013 Aspirin ASPIRIN L.N.K. International, Inc. 35005045-57b2-4ffe-ab70-22d570c1b161 2025-12-22 Warnings Exact identifier application number: M013 Tension Headache Relief ACETAMINOPHEN, CAFFEINE NUVICARE LLC ea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Walmart 175495fd-c561-f813-e063-6294a90aac80 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALMART INC 21b22e9f-b6d1-1819-e063-6294a90ae09c 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine HCL ACETAMINOPHEN AND DIPHENHYDRAMINE HCL SAFEWAY f18c1aa2-5f8b-5458-e053-2995a90ab947 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Meijer 181b3148-fa33-c650-e063-6294a90a0de6 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN TOPCO ASSOCIATES LLC 1a00a49e-f9ff-b928-e063-6394a90a4cb5 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PUBLIX SUPERMARKETS, INC 08f57305-0c4b-96b1-e063-6394a90a77df 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine HCL ACETAMINOPHEN AND DIPHENHYDRAMINE HCL PUBLIX SUPERMARKETS, INC 08f549cf-042a-7bf2-e063-6394a90a83ef 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALGREEN CO. b8a855ae-c0a3-0b05-e053-2a95a90ac8a8 2025-12-19 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Marc Glassman, Inc. f708e1ec-cf2a-4e2b-851f-f6b703f359b2 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALGREEN CO. b375de90-25c7-aa55-e053-2995a90a3cf8 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN TARGET CORPORATION e64a3c32-5466-0662-e053-2a95a90ae963 2025-12-19 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# 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