Home NDC 42507-700 cold and flu
Product NDC 42507-700
11-digit product format 425070700
Labeler code 42507
Product ID 42507-700_b3ca6e48-d138-429e-9d37-33ffc2642e80
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler HyVee Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-09-24
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 5 mg/1; mg/1; mg/1
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
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 · 36 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 cold and flu
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
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 1086997 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 COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [HYVEE INC] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [HYVEE INC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [HYVEE INC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [HYVEE INC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [HYVEE INC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [HYVEE INC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [HYVEE INC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [HYVEE INC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [HYVEE INC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [HYVEE INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [HYVEE INC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [HYVEE INC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [HYVEE INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [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 74 of 180 · 3,583 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42507-700-62 42507070062 12 BLISTER PACK in 1 CARTON (42507-700-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 12 blister pack 2014-09-24 No No Current