members mark mucus relief dm

Generic: guaifenesin and dextromethorphan hbr

Labeler: sam's west inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name members mark mucus relief dm
Generic Name guaifenesin and dextromethorphan hbr
Labeler sam's west inc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 60 mg/1, guaifenesin 1200 mg/1

Manufacturer
SAM'S WEST INC

Identifiers & Regulatory

Product NDC 68196-999
Product ID 68196-999_353ffab0-e812-3948-08ea-c649e60aa08f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA217340
Listing Expiration 2026-12-31
Marketing Start 2023-08-15

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68196999
Hyphenated Format 68196-999

Supplemental Identifiers

RxCUI
1099074
UNII
9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name members mark mucus relief dm (source: ndc)
Generic Name guaifenesin and dextromethorphan hbr (source: ndc)
Application Number ANDA217340 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
  • 1200 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (68196-999-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

68196-999-56 4 BLISTER PACK in 1 CARTON (68196-999-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

dextromethorphan hydrobromide (60 mg/1) guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Members Mark Mucus Relief DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "353ffab0-e812-3948-08ea-c649e60aa08f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1099074"], "spl_set_id": ["2b59f90b-b8fc-03c0-3527-a8efa97fbfe3"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["SAM'S WEST INC"]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (68196-999-56)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "68196-999-56", "marketing_start_date": "20240530"}], "brand_name": "Members Mark Mucus Relief DM", "product_id": "68196-999_353ffab0-e812-3948-08ea-c649e60aa08f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["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]"], "product_ndc": "68196-999", "generic_name": "Guaifenesin and Dextromethorphan HBR", "labeler_name": "SAM'S WEST INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Members Mark Mucus Relief DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "60 mg/1"}, {"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA217340", "marketing_category": "ANDA", "marketing_start_date": "20230815", "listing_expiration_date": "20261231"}