Cold and Flu Nighttime Relief

Product NDC
50844-793
11-digit product format
508440793
Labeler code
50844
Product ID
50844-793_17795a85-ef6f-4f7f-95fc-ffbd2162f11d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-03-17
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
325 mg/1; mg/1; mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-793-21508440793212 BLISTER PACK in 1 CARTON (50844-793-21) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2021-03-170000-00-00NoNoCurrent