Cough Syrup DM

Product NDC
35418-119
11-digit product format
354180119
Labeler code
35418
Product ID
35418-119_f19c0138-c1bc-9420-e053-2995a90a0e59
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorpham HBr
Dosage form
SYRUP
Route
ORAL
Labeler
Zee Medical Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-06-12
Marketing end
2023-03-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35418-119-372023-01-06C16284748780-1ba0f9c33-1485-a910-e053-dadaa90a0b85ab331af1-5edf-4f6b-9ee8-bf1d69d70e88
35418-119-372021-01-29C16284748780-1ba0f9c33-1485-a910-e053-dadaa90a0b85ab331af1-5edf-4f6b-9ee8-bf1d69d70e88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35418-119-37354180119376 PACKET in 1 CARTON (35418-119-37) > 10 mL in 1 PACKET (35418-119-42) 6 packet2012-06-122023-03-01NoNoCurrent