Home NDC 49580-0416 Severe cold and flu
Product NDC 49580-0416
11-digit product format 495800416
Labeler code 49580
Product ID 49580-0416_46f4b7c3-c197-4717-8036-499652b0d716
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI
Dosage form LIQUID
Route ORAL
Labeler P & L Development, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-08-31
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 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
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 49580-0416-8 Severe cold and fluNighttime 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0416 SEVERE COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC] 7 Current NDC, Legacy NDC, 1 package rows 20240426_7c92bdcf-db1f-4299-982f-6a3da9cba6e6.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 76 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HEB SF Honey Lemon Cough Drops MENTHOL HEB d09ed4bb-7595-5e54-e053-2a95a90aa109 2025-12-13 Warnings Exact identifier application number: M012 HEB Cherry Cough Drops MENTHOL HEB c198e3c7-5ba7-ece6-e053-2995a90adb38 2025-12-13 Warnings Exact identifier application number: M012 HEB Honey Lemon Cough Drops MENTHOL HEB c19a79bc-9872-2e87-e053-2a95a90a9427 2025-12-13 Warnings Exact identifier application number: M012 Cold and Flu Daytime Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL WALMART INC. 26f55169-4b37-4a36-88ee-064d6e962065 2025-12-12 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL Walgreen Company 39ce76a3-b7a8-43be-9b61-5c1446cd9e90 2025-12-12 Warnings Exact identifier application number: M012 Cold and Flu maximum strength ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Rite Aid Corporation ac01206f-a717-4c0b-8a03-fab0a4fd154b 2025-12-12 Warnings Exact identifier application number: M012 Sinus Severe ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL Strategic Sourcing Services LLC dcb80dd5-465d-4792-947a-3044e25a5284 2025-12-12 Warnings Exact identifier application number: M012 Vapor Rub COUGH SUPPRESSANT Neilmed Pharmaceuticals Inc. 39190f9f-8a5a-e4d8-e063-6294a90a57dd 2025-12-12 Warnings Exact identifier application number: M012 Medicated Chest Rub CAMPHOR, EUCALYPTUS OIL, MENTHOL Cardinal Health, 110 dba LEADER b7393668-1450-4e85-9793-d400daf39b43 2025-12-12 Warnings Exact identifier application number: M012 Allergy Relief, 24-7 Life by 7-Eleven DIPHENHYDRAMINE HCL TABLET, FILM COATED Lil' Drug Store Products, Inc. 45c4cd6c-327d-5950-e063-6394a90a3a21 2025-12-12 Warnings Exact identifier application number: M012 Menthol cough drops MENTHOL Family Dollar 44bb3b95-b2ba-470e-e054-00144ff88e88 2025-12-12 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Family Dollar 44bb9c7b-994b-4ab8-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Family Dollar 44be9837-f15a-09f2-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Family Dollar 44bcae39-2389-09ee-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Family Dollar 46635813-66c4-504c-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Family Dollar 455b0f4b-0526-2361-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 Family Wellness Strawberry Cough Drops MENTHOL Family Dollar f92466ac-dd93-9ac5-e053-6294a90a9291 2025-12-12 Warnings Exact identifier application number: M012 GoodSense Menthol Cough Drops MENTHOL Geiss, Destin, Dunn c6b25d69-8930-6867-e053-2a95a90ad208 2025-12-12 Warnings Exact identifier application number: M012 Good Sense Cherry Cough Drops MENTHOL Geiss, Destin, Dunn c72db7f0-9324-8ed2-e053-2995a90a9868 2025-12-12 Warnings Exact identifier application number: M012 Good Sense Honey Lemon Cough Drops MENTHOL Geiss, Destin, Dunn c72e557f-0211-81b9-e053-2995a90a1437 2025-12-12 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 Marketing end Sample Exclude flag Status 49580-0416-8 49580041608 237 mL in 1 BOTTLE, PLASTIC (49580-0416-8) 237 ml 2015-08-31 0000-00-00 No No Current