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 80 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join cherry throat relief lozenges BENZOCAINE Cintas Corporation 49b25e9e-1d47-4a10-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 cherry sore throat lozenge BENZOCAINE CVS Pharmacy 3c54974d-9d15-2fa1-e054-00144ff88e88 2025-12-07 Warnings Exact identifier application number: M012 honey lemon sore throat lozenges BENZOCAINE CVS Pharmacy 3c55009c-4b3e-135e-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 sugar free menthol cough drops MENTHOL CVS Pharmacy 3bdd24a8-3b44-00cd-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL CVS Pharmacy 3c125b3a-e58f-5c06-e054-00144ff88e88 2025-12-07 Warnings Exact identifier application number: M012 CVS Menthol Cough Drops MENTHOL CVS Pharmacy de97d13b-bb67-d0e6-e053-2995a90aeb2c 2025-12-07 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL American Sales 34dd34d1-1a08-3470-e054-00144ff8d46c 2025-12-06 Warnings Exact identifier application number: M012 DOLOGEN ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE Kramer Novis 656ea9ba-c9cf-44c6-af40-b8ba292ce38a 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Severe Congestion OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC a79b5541-864b-412a-a085-96986ed6af59 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Extra Moisturizing OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. 346f32cb-74cb-4896-b770-76d5f829a17d 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Original Pump Mist OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. 530b2d27-5883-489e-87fa-90b45eb93b3c 2025-12-05 Warnings Exact identifier application number: M012 Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE Bayer HealthCare LLC. ee666963-e686-4374-b52b-a677f1cd4114 2025-12-05 Warnings Exact identifier application number: M012 Afrin No-Drip Allergy Sinus OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC 3beb5839-7422-449d-e054-00144ff88e88 2025-12-05 Warnings Exact identifier application number: M012 Coricidin HBP Nighttime Multi-Symptom Cold ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE Bayer HealthCare LLC. 513ca24f-1262-4a2d-e054-00144ff8d46c 2025-12-05 Warnings Exact identifier application number: M012 Afrin Severe Congestion OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. a49a506e-aca2-4af0-a50b-dca2c031e61d 2025-12-05 Warnings Exact identifier application number: M012 Throat Coat Sweet Orange Fennel MENTHOL Traditional Medicinals, Inc. a746cef4-1fb4-45cf-e053-2995a90a02c8 2025-12-05 Warnings Exact identifier application number: M012 Guaifenesin GUAIFENESIN Health Pharma USA LLC 31755594-3e1c-b290-e063-6394a90aba61 2025-12-05 Warnings Exact identifier application number: M012 Tabcin Extra Strength ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, Pharmadel LLC 0670c33e-8a3c-ae00-e063-6294a90a165b 2025-12-05 Warnings Exact identifier application number: M012 Severe Sinus Congestion and Pain ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE Shield Pharmaceuticals Corp d0dd4a75-da65-4c66-b65f-54ee14100846 2025-12-05 Warnings Exact identifier application number: M012 Basic Care Cherry Cough Drops MENTHOL Amazon.com c0588221-0c84-66d8-e053-2995a90a874f 2025-12-05 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