Home NDC 50804-468 Daytime
Product NDC 50804-468
11-digit product format 508040468
Labeler code 50804
Product ID 50804-468_54ddfe02-4885-42d0-8f53-3456375824ae
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Good Sense (Geiss, Destin & Dunn, Inc.)
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-08-31
Marketing end 2025-01-31
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 18 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 CARMINIC ACID INACTIVE INGREDIENT CID8Z8N95N DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 SODIUM METABISULFITE INACTIVE INGREDIENT 4VON5FNS3C DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50804-468-16 50804046816 16 BLISTER PACK in 1 CARTON (50804-468-16) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 16 blister pack 2015-08-31 2025-01-31 No No Current 50804-468-24 50804046824 24 BLISTER PACK in 1 CARTON (50804-468-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 24 blister pack 2015-08-31 2025-01-31 No No Current