MedPath

Cough DM

Meijer Distribution, Inc. Cough DM Drug Facts

Approved
Approval ID

6bdfa599-7898-4c05-927c-52fb82e0e686

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 4, 2025

Manufacturers
FDA

Meijer Distribution Inc

DUNS: 006959555

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 Code41250-494
Application NumberANDA091135
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextromethorphan polistirex
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2025
FDA Product Classification

INGREDIENTS (18)

DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 30 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SODIUM POLYSTYRENE SULFONATEInactive
Code: 1699G8679Z
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TRAGACANTHInactive
Code: 2944357O2O
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Cough DM - FDA Drug Approval Details