Home NDC 59779-597 Severe Nighttime Severe Daytime
Product NDC 59779-597
11-digit product format 597790597
Labeler code 59779
Product ID 59779-597_479ff3f6-5444-4bb2-9c8f-e66ea39dde51
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
Dosage form KIT
Labeler CVS Pharmacy
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-12-27
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 Severe Nighttime Severe 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59779-597-02 Severe Nighttime Severe Daytime 1 in 1 CARTON KIT 1 6 59779-603-40 Severe Nighttime Severe Daytime 355 mL in 1 BOTTLE SOLUTION 355 mL 200 mg in 15mL 6 59779-763-40 Severe Nighttime Severe Daytime 355 mL in 1 BOTTLE SOLUTION 355 mL 650 mg in 30mL 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 MENTHOL INACTIVE INGREDIENT L7T10EIP3A SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59779-597 SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] 5 Current NDC, Legacy NDC, 3 package rows 20250117_1ec3fc79-4f38-439f-99be-646b82231aa5.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 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2637731 {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack GPCK 1ec3fc79-4f38-439f-99be-646b82231aa5 6 2637731 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack PSN 1ec3fc79-4f38-439f-99be-646b82231aa5 6 1369842 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution PSN 1ec3fc79-4f38-439f-99be-646b82231aa5 6 1431245 acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution PSN 1ec3fc79-4f38-439f-99be-646b82231aa5 6 1431245 acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution SCD 1ec3fc79-4f38-439f-99be-646b82231aa5 6 1369842 acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution SCD 1ec3fc79-4f38-439f-99be-646b82231aa5 6 2637731 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack SY 1ec3fc79-4f38-439f-99be-646b82231aa5 6 1431245 acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution SY 1ec3fc79-4f38-439f-99be-646b82231aa5 6 1369842 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution SY 1ec3fc79-4f38-439f-99be-646b82231aa5 6 1431245 acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution SY 1ec3fc79-4f38-439f-99be-646b82231aa5 6 1369842 acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution SY 1ec3fc79-4f38-439f-99be-646b82231aa5 6 1431245 APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution SY 1ec3fc79-4f38-439f-99be-646b82231aa5 6 1369842 APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution SY 1ec3fc79-4f38-439f-99be-646b82231aa5 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59779-597-02 59779059702 1 KIT in 1 CARTON (59779-597-02) * 355 mL in 1 BOTTLE (59779-763-40) * 355 mL in 1 BOTTLE (59779-603-40) 1 kit 2013-12-27 0000-00-00 No No Current 59779-603-40 59779060340 355 mL in 1 BOTTLE 355 ml Historical 59779-763-40 59779076340 355 mL in 1 BOTTLE 355 ml Historical