Home NDC 42507-020 Severe Cold and Flu
Product NDC 42507-020
11-digit product format 425070020
Labeler code 42507
Product ID 42507-020_09897636-515d-4457-983f-c3e6e601c71a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
Dosage form SOLUTION
Route ORAL
Labeler HyVee Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-09-08
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL DOXYLAMINE SUCCINATE 12.5 mg/30mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL
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 1431245 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 42507-020-34 Severe Cold and Flu 237 mL in 1 BOTTLE SOLUTION 237 4 42507-020-40 Severe Cold and Flu 355 mL in 1 BOTTLE SOLUTION 355 4
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, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] 1
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 100 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Freegells Cough Drops Menthol 80ct MENTHOL RL Albert & Son Inc. c96cc162-5908-4990-9dc1-3ce912844274 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 30ct MENTHOL R.L. ALBERT & SON, INC bac77712-6197-4b30-a5f8-9b99eb9d7b5a 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL R.L. ALBERT & SON, INC 6842d766-ade6-40b2-831b-f4feac25c6db 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL RL Albert & Son Inc. 9f324ca1-0e2a-47e3-997e-2aaa68a85751 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 30ct MENTHOL R.L. ALBERT & SON, INC 2063a013-aa0b-465d-b04f-cfe2e70d749f 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 200ct MENTHOL R.L. ALBERT & SON, INC cd81488c-74d8-48d9-9c73-ff662a5cd4cd 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 80ct MENTHOL R.L. ALBERT & SON, INC 61deea94-d0a9-4563-926b-53f255a7c425 2025-10-08 Warnings Exact identifier application number: M012 FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS MENTHOL R.L. ALBERT & SON, INC c6b36350-386b-4346-bef0-a37ec11319c0 2025-10-08 Warnings Exact identifier application number: M012 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Strategic Sourcing Services LLC 3314b174-d5bb-4843-9288-9b9c5fce79d5 2025-10-08 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL CVS Pharmacy 22f55699-4922-4c05-bdf5-5844c7dd3ee5 2025-10-07 Warnings Exact identifier application number: M012 OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution DIPHENHYDRAMINE HCL MEDWISE LIFESCIENCES INC. 407b7cbb-7ebd-7b7e-e063-6394a90af501 2025-10-06 Warnings Exact identifier application number: M012 Quality Choice Medicated Chest Rub CAMPHOR, MENTHOL, EUCALYPTUS OIL Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc 2025-10-06 Warnings Exact identifier application number: M012 Halls Sugar Free Honey Lemon MENTHOL Mondelez Global LLC 2b19fdd2-8088-47f2-be20-f220a6b825fc 2025-10-06 Warnings Exact identifier application number: M012 Giltuss Childrens Cough and Chest Congestion DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Dextrum Laboratories, Inc 40802fb6-c1ec-d7b0-e063-6394a90ab423 2025-10-06 Warnings Exact identifier application number: M012 Giltuss Diabetic DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Dextrum Laboratories, Inc 3f64c81a-bbfc-4575-e063-6294a90a6ed7 2025-10-06 Warnings Exact identifier application number: M012 TexaClear Severe Cough, Cold and Flu CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN GM Pharmaceuticals, INC cb99e5b3-1908-43c9-b31f-d35e7ce58b44 2025-10-06 Warnings Exact identifier application number: M012 RoboHBr Cough SUPPRESSANT DEXTROMETHORPHAN HBR DXM Pharmaceutical, Inc 0af624ce-191f-45e1-882b-e8acb90cc77b 2025-10-06 Warnings Exact identifier application number: M012 RoboTablets DEXTROMETHORPHAN DXM Pharmaceutical, Inc b92cf698-032d-4d8d-b19c-456c6338b094 2025-10-06 Warnings Exact identifier application number: M012 SinuLief LORATADINE RoseWell Pharmaceuticals LLC 32619143-a782-3497-e063-6394a90aaaec 2025-10-06 Warnings Exact identifier application number: M012 STAHIST AD CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE Magna Pharmaceuticals, Inc. ccedbc38-2479-4c35-9f86-a9f29bcfab3f 2025-10-03 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 42507-020-34 42507002034 237 mL in 1 BOTTLE 237 ml Historical 42507-020-40 42507002040 355 mL in 1 BOTTLE (42507-020-40) 355 ml 2015-09-08 No No Current