Home NDC 49580-0343 Night Time Cold and Flu
Product NDC 49580-0343
11-digit product format 495800343
Labeler code 49580
Product ID 49580-0343_6b8c5604-2fc0-4acb-a71e-0a9ae331fd4e
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form LIQUID
Route ORAL
Labeler P & L Development, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-10-31
Marketing end 2026-12-31
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes 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]
NDC exclude flag No
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 · 5 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 Night Time Cold and Flu
Brand name suffix ReadyInCase Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL DOXYLAMINE SUCCINATE 12.5 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043400 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49580-0343-2 Night Time Cold and FluReadyInCase 355 mL in 1 BOTTLE, PLASTIC LIQUID 355 13 49580-0343-4 Night Time Cold and FluReadyInCase 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 13 49580-0343-6 Night Time Cold and FluReadyInCase 177 mL in 1 BOTTLE, PLASTIC LIQUID 177 13 49580-0343-8 Night Time Cold and FluReadyInCase 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0343 NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [P & L DEVELOPMENT, LLC] 11 Current NDC, Legacy NDC, 4 package rows 20241211_e7dd763b-3005-4723-933b-171eb772afee.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 131 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. db2ab9be-507d-4768-9d00-188f751b7726 2024-12-10 Warnings Exact identifier application number: M012 Adult Allergy Relief CALMCO ALLERGY RELIEF CalmCo 08288825-0f38-b6a3-e063-6394a90aa358 2024-12-07 Warnings Exact identifier application number: M012 Original Herb Cough Drops MENTHOL Ricola Ag c142663f-086e-4ab7-a758-9107d7077537 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 984c9793-163c-4b97-b244-9b471966a122 2024-12-05 Warnings Exact identifier application number: M012 BENZEDREX PROPYLHEXEDRINE BF ASCHER AND CO INC 00d8c237-3eee-1d9f-e063-6394a90aeb86 2024-12-05 Warnings Exact identifier application number: M012 Cold Multi Symptom Daytime Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE Chain Drug Marketing Association d5cbb5b0-564c-429e-b680-fa683e796393 2024-12-05 Warnings Exact identifier application number: M012 Cold Relief Multi-Symptom ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCare de8a623f-7b10-4d56-a74b-3737e7716ffe 2024-12-05 Warnings Exact identifier application number: M012 Cold Max Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 9773958b-c5e5-4da7-a8e9-6b6c223a2b30 2024-12-05 Warnings Exact identifier application number: M012 Cold Plus Head Congestion Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 399e0e51-c2a7-451c-b74d-d3db140cef69 2024-12-05 Warnings Exact identifier application number: M012 Head Congestion Plus Mucus PE ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE United Natural Foods, Inc. dba UNFI 09531edc-8dbd-451f-ae02-f922e9e8c248 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 71ca8af7-172d-40da-be1e-ff3ab5568e74 2024-12-05 Warnings Exact identifier application number: M012 SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola Ag b790a91c-33be-4bc3-bdeb-eae6f366f085 2024-12-05 Warnings Exact identifier application number: M012 EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola Ag ea42e516-2ef8-41c9-ae4e-571f0147bc6b 2024-12-05 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola Ag 8b2d5c0f-509e-447d-b071-d73c4785f120 2024-12-05 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola Ag 8ae0e21a-44a0-4a2c-9880-54eeeaea07ea 2024-12-05 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 6d82469b-d51c-4824-9830-6c1874ad4fe4 2024-12-05 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola Ag e8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce5 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag a535717d-ba55-45e9-9fc3-711b5d7dbf57 2024-12-05 Warnings Exact identifier application number: M012 THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL Ricola Ag 4330ee8d-0b37-4a93-886b-5fc6e6598da7 2024-12-05 Warnings Exact identifier application number: M012 COLD AND FLU DAYTIME SEVERE ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TARGET CORP 9de99931-31ef-79e2-e053-2a95a90a98ad 2024-12-04 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 49580-0343-2 49580034302 355 mL in 1 BOTTLE, PLASTIC (49580-0343-2) 355 ml 2014-10-31 2026-12-31 No No Current 49580-0343-4 49580034304 118 mL in 1 BOTTLE, PLASTIC (49580-0343-4) 118 ml 2014-10-31 2026-12-31 No No Current 49580-0343-6 49580034306 177 mL in 1 BOTTLE, PLASTIC (49580-0343-6) 177 ml 2014-10-31 2026-12-31 No No Current 49580-0343-8 49580034308 237 mL in 1 BOTTLE, PLASTIC (49580-0343-8) 237 ml 2014-10-31 2026-12-31 No No Current