Home NDC 42507-597 Severe Cold and Flu
Product NDC 42507-597
11-digit product format 425070597
Labeler code 42507
Product ID 42507-597_7172be88-9cab-4bf7-9882-e41ac912ea4c
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
Dosage form KIT
Labeler HyVee Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-05-19
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42507-597-02 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42507-597-02 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42507-597-02 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42507-597-02 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42507-597-02 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42507-597-02 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42507-597-02 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42507-597-02 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42507-597-02 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42507-597-02 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42507-597-02 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42507-597-02 557ba5c1ecfa…9c80585c8c6e…
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
Brand name suffix Nighttime Daytime
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1369842 Internal RxNorm lookup 1431245 Internal RxNorm lookup 2637731 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 MENTHOL INACTIVE INGREDIENT L7T10EIP3A SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [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 73 of 178 · 3,551 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42507-597-02 42507059702 1 KIT in 1 CARTON (42507-597-02) * 355 mL in 1 BOTTLE * 355 mL in 1 BOTTLE 1 kit 2014-05-19 No No Current