Severe Cold and Cough

Product NDC
36800-316
11-digit product format
368000316
Labeler code
36800
Product ID
36800-316_14df443e-79d1-4c2d-8a0c-0fbf7b55953d
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
Dosage form
LIQUID
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-30
Marketing end
2026-05-28
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 20; 10 mg/30mL; mg/30mL; mg/30mL
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-316SEVERE COLD AND COUGH DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]5Current NDC, Legacy NDC20231014_c6475e58-5152-4dad-be2f-4ca32b8589d7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-316-0836800031608245 mL in 1 BOTTLE, PLASTIC (36800-316-08) 245 ml2015-11-302026-05-28NoNoCurrent