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 76 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen Extra Strength ACETAMINOPHEN Aurohealth LLC 03d42892-4465-4089-90a7-cd5f00c35602 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Aurohealth LLC 57bb1acc-b9a0-48cd-8e5c-33712441ce81 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN Aurohealth LLC cc0ab7a1-e535-4dc8-962f-c58949fc1737 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Aurohealth LLC a4ff94b9-c248-4cd3-8491-38e9555cc22e 2023-11-29 Warnings Exact identifier application number: M013 Aurophen Extra Strength for Adults ACETAMINOPHEN Aurohealth LLC d59c5f04-4bcc-4a52-a42f-e049506f00de 2023-11-29 Warnings Exact identifier application number: M013 Aurophen Extra Strength for Adults ACETAMINOPHEN Aurohealth LLC a769094b-1e91-4ca7-ba67-21aa7e312910 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Aurohealth LLC 30756257-f748-4a5d-b031-dd267d0f91ad 2023-11-29 Warnings Exact identifier application number: M013 Aurophen Regular Strength ACETAMINOPHEN Aurohealth LLC 8eda893f-5266-4b7a-95b9-2e194973cf06 2023-11-29 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN Aurohealth LLC 00ec6518-b5e3-49d1-a342-139381c3bfd2 2023-11-29 Warnings Exact identifier application number: M013 CHILDRENS PAIN RELIEF ACETAMINOPHEN Better Living Brands, LLC fadb4c09-071f-56c0-e053-6294a90ae6c1 2023-11-28 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine hydrochloride ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Better Living Brands, LLC fc07d516-9ffe-9989-e053-6294a90ae1a5 2023-11-28 Warnings Exact identifier application number: M013 NOTTS - Tension Headache ACETAMINOPHEN, CAFFEINE VIVUNT PHARMA LLC 08f2ae03-967b-ad7e-e063-6294a90a8484 2023-11-24 Warnings Exact identifier application number: M013 Sanatos Multi Symptoms Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Pharmadel LLC 0a60326a-a17b-e843-e063-6394a90ac211 2023-11-22 Warnings Exact identifier application number: M013 Sanatos Nighttime Multi Symptoms ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Pharmadel LLC 0ab188f3-f7f9-d665-e063-6294a90a198a 2023-11-22 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN TIME CAP LABS INC fe12519c-3e5f-4592-bd34-2d6b81b981f4 2023-11-22 Warnings Exact identifier application number: M013 Rugby Regular Strength Acetaminophen ACETAMINOPHEN A-S Medication Solutions 400d4a29-9e39-4e74-8272-37be5d789924 2023-11-22 Warnings Exact identifier application number: M013 RIGHT REMEDIES Pain Relief Extra Strength Caplet ACETAMINOPHEN Strive Pharmaceuticals Inc. dcce28d9-8528-489e-b995-1d98e9d0e6ad 2023-11-21 Warnings Exact identifier application number: M013 Sanatos Multi Symptom Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI Pharmadel LLC 0ab11691-5b29-55fc-e063-6394a90aa328 2023-11-17 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN A-S Medication Solutions 1e223faa-f6d0-4235-bc4c-6cfca84a5b0a 2023-11-17 Warnings Exact identifier application number: M013 SanaTos X ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI Pharmadel LLC 85b8ef3d-7318-7f3b-e053-2991aa0a0777 2023-11-14 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