dextromethorphan hbr,guaifenesin

Generic: dextromethorphan hbr,guaifenesin

Labeler: softgel healthcare private limited
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dextromethorphan hbr,guaifenesin
Generic Name dextromethorphan hbr,guaifenesin
Labeler softgel healthcare private limited
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 35916-0760
Product ID 35916-0760_47b53021-eb30-c736-e063-6294a90ae369
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2025-03-21

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 359160760
Hyphenated Format 35916-0760

Supplemental Identifiers

RxCUI
1111663
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 dextromethorphan hbr,guaifenesin (source: ndc)
Generic Name dextromethorphan hbr,guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0760-1)
source: ndc

Packages (1)

35916-0760-1 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0760-1)

Ingredients (2)

dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1)

Linked Drug Pages (1)

Dextromethorphan Hbr,Guaifenesin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47b53021-eb30-c736-e063-6294a90ae369", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1111663"], "spl_set_id": ["2fbbfc7c-81a9-b647-e063-6394a90a55ac"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["SOFTGEL HEALTHCARE PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0760-1)", "package_ndc": "35916-0760-1", "marketing_start_date": "20250321"}], "brand_name": "Dextromethorphan Hbr,Guaifenesin", "product_id": "35916-0760_47b53021-eb30-c736-e063-6294a90ae369", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "35916-0760", "generic_name": "Dextromethorphan Hbr,Guaifenesin", "labeler_name": "SOFTGEL HEALTHCARE PRIVATE LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dextromethorphan Hbr,Guaifenesin", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250321", "listing_expiration_date": "20271231"}