Home NDC 0113-0548 Good Sense Severe Daytime
Product NDC 0113-0548
11-digit product format 001130548
Labeler code 0113
Product ID 0113-0548_fa4af50a-045b-41f6-91f5-7c6329ad5c28
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler L. Perrigo Company
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-11-19
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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 · 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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GOOD SENSE SEVERE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0113-0548-53 00113054853 6 BLISTER PACK in 1 CARTON (0113-0548-53) > 2 TABLET, FILM COATED in 1 BLISTER PACK 6 blister pack 2013-11-21 0000-00-00 No No Current 0113-0548-62 00113054862 12 BLISTER PACK in 1 CARTON (0113-0548-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK 12 blister pack 2013-11-19 0000-00-00 No No Current