Home NDC 42507-603 Severe Cold and Flu
Product NDC 42507-603
11-digit product format 425070603
Labeler code 42507
Product ID 42507-603_210dc303-8239-4828-a369-39853a2a1308
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Dosage form SOLUTION
Route ORAL
Labeler HyVee Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-01-12
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Severe Cold and Flu
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/15mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL GUAIFENESIN 200 mg/15mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/15mL
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 1369842 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 42507-603-34 Severe Cold and Flu 237 mL in 1 BOTTLE SOLUTION 237 6 42507-603-40 Severe Cold and Flu 355 mL in 1 BOTTLE SOLUTION 355 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 MENTHOL INACTIVE INGREDIENT L7T10EIP3A SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 2
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 118 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join daytime severe cold multi-symptom ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL United Natural Foods, Inc. dba UNFI cc7c5f1c-76b7-4278-8e2a-5fbc85e022dd 2025-03-08 Warnings Exact identifier application number: M012 Cold and Head Congestion Relief Severe ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL WinCo Foods, LLC a39778ba-1f63-4495-8e9b-44b0bdd7f71a 2025-03-08 Warnings Exact identifier application number: M012 Extra Strength TYLENOL Severe Cough Plus Sore Throat Day ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE Kenvue Brands LLC 2e9540e4-bd1d-9370-e063-6294a90affcb 2025-03-07 Warnings Exact identifier application number: M012 Herbal Cough Drops Original Herb COUGH DROPS Topco Associates LLC 2fb22181-aee3-d0bf-e063-6294a90a7865 2025-03-06 Warnings Exact identifier application number: M012 REVASOL DAYTIME COLD AND FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE Rnv LLC 2f9ddcc3-b913-f8b0-e063-6294a90a93ab 2025-03-05 Warnings Exact identifier application number: M012 Herbal Throat Drops Lemon Mint Herb THROAT DROPS Topco Associates LLC 2fa086b4-3b0e-0df8-e063-6294a90a6769 2025-03-05 Warnings Exact identifier application number: M012 Redicare Nasal and Sinus Decongestant REDICARE NASAL AND SINUS DECONGESTANT Redicare LLC 2f24be68-f30e-d916-e063-6294a90a7e31 2025-03-04 Warnings Exact identifier application number: M012 Diphenhydramine HCl Oral Solution DIPHENHYDRAMINE HCL ORAL SOLUTION Kesin Pharma Corporation 2f871005-de4d-8b2a-e063-6394a90aa43a 2025-03-04 Warnings Exact identifier application number: M012 CVS Daytime Cough Relief Chews - Citrus Punch DEXTROMETHORPHAN HBR CVS 2f885f1b-7ff5-251b-e063-6394a90a656f 2025-03-04 Warnings Exact identifier application number: M012 CVS Dex-Dox Kids Nighttime Cough Suppressant DEXTROMETHORPHAN HBR CVS 2f8b6f5e-399c-b033-e063-6294a90ac3d1 2025-03-04 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ff8b096c-8f01-4a8c-a98f-e4aa4d688e95 2025-03-04 Warnings Exact identifier application number: M012 Menthol Cough Drops Honey Vanilla Flavor MENTHOL 7-ELEVEN 2f3c43dd-175f-722e-e063-6294a90acff9 2025-02-28 Warnings Exact identifier application number: M012 Menthol Cough Drops Creamy Strawberry Flavor MENTHOL AND PECTIN 7-ELEVEN 2f3c3c65-4178-6304-e063-6294a90a51fa 2025-02-28 Warnings Exact identifier application number: M012 Menthol Cough Drops Creamy Strawberry Flavor MENTHOL AND PECTIN Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 2efbffd7-bbdd-c5f5-e063-6294a90a15f0 2025-02-25 Warnings Exact identifier application number: M012 Menthol Cough Drops Honey Vanilla Flavor MENTHOL Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 2efc46c9-a421-1998-e063-6394a90aeb64 2025-02-25 Warnings Exact identifier application number: M012 Redicare Cough Drops Cherry Flavored CHERRY FLAVORED MENTHOL COUGH DROPS Redicare LLC 2efeaafa-ee96-37ee-e063-6394a90a9a4b 2025-02-25 Warnings Exact identifier application number: M012 Childrens Allergy DIPHENHYDRAMINE HCL Genexa Inc. e880b8d7-61c3-41cc-e053-2995a90aaaeb 2025-02-20 Warnings Exact identifier application number: M012 Gencare-Nasal Decongestant PE PHENYLEPHRINE HYDROCHLORIDE Pioneer Life Sciences, LLC 596ec923-56a0-4b6e-a69c-8d740feb75a2 2025-02-20 Warnings Exact identifier application number: M012 Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Kenvue Brands LLC 77a2dc96-73ee-4ca2-b1fe-406995802606 2025-02-19 Warnings Exact identifier application number: M012 nasal decongestant OXYMETAZOLINE HYDROCHLORIDE Safeway f1d0edd5-fe58-4de0-98f4-07fb24bd0ac2 2025-02-19 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42507-603-34 42507060334 237 mL in 1 BOTTLE 237 ml Historical 42507-603-40 42507060340 355 mL in 1 BOTTLE (42507-603-40) 355 ml 2014-01-12 No No Current