cosedal drops

Generic: dextromethorphan hbr, guaifenesin

Labeler: menper distributors, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cosedal drops
Generic Name dextromethorphan hbr, guaifenesin
Labeler menper distributors, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/5mL, guaifenesin 100 mg/5mL

Manufacturer
Menper Distributors, Inc.

Identifiers & Regulatory

Product NDC 53145-059
Product ID 53145-059_3a8a3022-d085-1ccf-e063-6394a90a90ed
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2012-02-21

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 53145059
Hyphenated Format 53145-059

Supplemental Identifiers

RxCUI
996520
UNII
9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

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 cosedal drops (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (53145-059-02) / 60 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

53145-059-02 1 BOTTLE, DROPPER in 1 CARTON (53145-059-02) / 60 mL in 1 BOTTLE, DROPPER

Ingredients (2)

dextromethorphan hydrobromide (10 mg/5mL) guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

Cosedal Drops ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a8a3022-d085-1ccf-e063-6394a90a90ed", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["1241d249-ea3b-4d2b-87ed-835d6a2d286a"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Menper Distributors, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (53145-059-02)  / 60 mL in 1 BOTTLE, DROPPER", "package_ndc": "53145-059-02", "marketing_start_date": "20120221"}], "brand_name": "Cosedal Drops", "product_id": "53145-059_3a8a3022-d085-1ccf-e063-6394a90a90ed", "dosage_form": "LIQUID", "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": "53145-059", "generic_name": "Dextromethorphan HBR, Guaifenesin", "labeler_name": "Menper Distributors, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cosedal Drops", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120221", "listing_expiration_date": "20261231"}