Home NDC 49580-0466 Daytime Cold and Flu
Product NDC 49580-0466
11-digit product format 495800466
Labeler code 49580
Product ID 49580-0466_a89992d4-6dd6-4a8c-8b3a-3fc1b63a1e75
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler P & L Development, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-06-30
Marketing end 2027-01-30
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes Adrenergic alpha1-Agonists [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
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 Daytime Cold and Flu Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/15mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/15mL
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 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1113705 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 49580-0466-1 Daytime Cold and Flu 296 mL in 1 BOTTLE, PLASTIC LIQUID 296 11 49580-0466-2 Daytime Cold and Flu 355 mL in 1 BOTTLE, PLASTIC LIQUID 355 11 49580-0466-4 Daytime Cold and Flu 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 11 49580-0466-6 Daytime Cold and Flu 177 mL in 1 BOTTLE, PLASTIC LIQUID 177 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0466 DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 10 Current NDC, Legacy NDC, 4 package rows 20240426_0bb006f6-c360-4cd5-81e9-0776d99d79e8.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49580-0466-1 49580046601 296 mL in 1 BOTTLE, PLASTIC (49580-0466-1) 296 ml 2015-06-30 2027-01-30 No No Current 49580-0466-2 49580046602 355 mL in 1 BOTTLE, PLASTIC (49580-0466-2) 355 ml 2015-06-30 2027-01-30 No No Current 49580-0466-4 49580046604 118 mL in 1 BOTTLE, PLASTIC (49580-0466-4) 118 ml 2015-06-30 2027-01-30 No No Current 49580-0466-6 49580046606 177 mL in 1 BOTTLE, PLASTIC (49580-0466-6) 177 ml 2015-06-30 2027-01-30 No No Current