Cough DM
Meijer Distribution, Inc. Cough DM Drug Facts
Approved
Approval ID
2f733ad1-b6f2-ebab-e063-6294a90abb9e
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Sep 15, 2025
Manufacturers
FDA
Sixarp, LLC
DUNS: 016329513
FDA
Praxis, LLC
DUNS: 016329513
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dextromethorphan polistirex
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59368-277
Application NumberANDA091135
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextromethorphan polistirex
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2025
FDA Product Classification
INGREDIENTS (19)
POLISTIREXInactive
Code: 5H9W9GTW27
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
SODIUM POLYSTYRENE SULFONATEInactive
Code: 1699G8679Z
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
TRAGACANTHInactive
Code: 2944357O2O
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 30 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 6/15/2020
Package/Label Principal Display Panel
Compare to Delsym® Orange Flavor active ingredient
cough DM
Dextromethorphan Polistirex
Extended-Release Oral Suspension
Cough Suppressant
12 HOUR Cough Relief
Orange-Flavored Liquid
Day or Night
Alcohol Free
Dosing Cup Included
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions
5 FL OZ (148 mL)
