Home NDC 0113-0096-91 good sense flu and severe cold and cough
Product NDC 0113-0096
Requested package NDC 0113-0096-91
11-digit product format 001130096
Labeler code 0113
Product ID 0113-0096_ab05b903-d505-456c-a87d-d4a1cac3088f
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler L. Perrigo Company
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-01-31
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650 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 2023-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4 TRIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT 91D9GV0Z28 GOOD SENSE FLU AND SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [L. PERRIGO COMPANY] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0113-0096-91 00113009691 6 POWDER, FOR SOLUTION in 1 CARTON (0113-0096-91) 2011-01-31 0000-00-00 No No Current