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 65 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join basic care acetaminophen pm ACETAMINOPHEN, DIPHENHYDRAMINE HCL Amazon.com Services LLC 64a0084a-e29e-4c1a-8704-13a3e1238f76 2024-07-17 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN Walmart Inc. 152c013a-c81c-f8f9-e063-6294a90a9f23 2024-07-15 Warnings Exact identifier application number: M013 Diphenhydramine HCL DIPHENHYDRAMINE HCL NuCare Pharmaceuticals, Inc. 5411544e-3c2d-4e42-e054-00144ff8d46c 2024-07-10 Warnings Exact identifier application number: M013 good sense pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL L. Perrigo Company b97c51ad-4953-4491-9ceb-395550eb5296 2024-07-10 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Walgreens 065e6f1b-f68c-491a-a157-84961a07e3d9 2024-07-10 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Walgreens 3b7b6725-2996-44d3-89a3-032384e7e2ce 2024-07-10 Warnings Exact identifier application number: M013 equate pain and fever infants ACETAMINOPHEN Wal-Mart Stores Inc 8a152c8d-8ae0-4201-8bb9-7b22c3577415 2024-07-10 Warnings Exact identifier application number: M013 Acetaminophen PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WinCo Foods, LLC 3c57498c-86b0-4ba3-881e-c742a2e8ece5 2024-07-09 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN WinCo Foods, LLC c358d1dd-9fcb-4d18-9521-8f898b98a732 2024-07-09 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN WinCo Foods, LLC 15430025-f25e-4fe7-b1fe-4eda4684081a 2024-07-09 Warnings Exact identifier application number: M013 Acetaminophen Easy Tabs Extra Strength ACETAMINOPHEN WinCo Foods, LLC 0631f003-4852-4034-a1c5-1552804b1660 2024-07-09 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Bryant Ranch Prepack 61ecf3c9-42fa-4ae4-bd3b-694090477b9a 2024-07-09 Warnings Exact identifier application number: M013 Panadol Cold and Flu NonDrowsy ACETAMINOPHEN AND PHENYLEPRINE HCL Haleon US Holdings LLC fa0ce51f-441d-4409-8617-b3402b00f187 2024-07-08 Warnings Exact identifier application number: M013 Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 81d4e8f5-2f15-462b-be71-ef05f0b791ab 2024-07-05 Warnings Exact identifier application number: M013 Extra Strength Pain Relief ACETAMINOPHEN Bryant Ranch Prepack 31a97a6a-e5c8-429a-b497-330f0d84777d 2024-07-05 Warnings Exact identifier application number: M013 pain and fever ACETAMINOPHEN Meijer Distribution Inc 375b2142-3c89-469c-98fd-bd4b63aeaa11 2024-07-05 Warnings Exact identifier application number: M013 Best Choice Effervescent Pain Reliever 36 ASPIRIN VALU MERCHANDISERS COMPANY 12f1278e-88b6-0460-e063-6394a90abf0e 2024-07-03 Warnings Exact identifier application number: M013 Topcare pain and fever ACETAMINOPHEN Topco Associates LLC 950b16d5-65db-402d-8ec6-eec9e1e174dd 2024-07-03 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN WALMART INC. 16d5b56f-7e56-0c91-e063-6394a90a4b8e 2024-07-03 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine hydrochloride ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WALMART INC. 16d5786c-2346-f970-e063-6394a90a0a8c 2024-07-03 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