acetaminophen, dextromethorphan hbr ,guaifenesin

Generic: acetaminophen, dextromethorphan hbr ,guaifenesin

Labeler: softgel healthcare pvt ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen, dextromethorphan hbr ,guaifenesin
Generic Name acetaminophen, dextromethorphan hbr ,guaifenesin
Labeler softgel healthcare pvt ltd
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1

Manufacturer
Softgel Healthcare Pvt Ltd

Identifiers & Regulatory

Product NDC 35916-0184
Product ID 35916-0184_47b54126-be68-dc81-e063-6294a90aaf7c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2025-05-17

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 359160184
Hyphenated Format 35916-0184

Supplemental Identifiers

RxCUI
2377385
UNII
362O9ITL9D 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 acetaminophen, dextromethorphan hbr ,guaifenesin (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr ,guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0184-2)
  • 2 POUCH in 1 BOX (35916-0184-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH
  • 2 BAG in 1 BOX (35916-0184-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (3)

35916-0184-2 3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0184-2) 35916-0184-3 2 POUCH in 1 BOX (35916-0184-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH 35916-0184-4 2 BAG in 1 BOX (35916-0184-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1)

Linked Drug Pages (1)

Acetaminophen, Dextromethorphan HBr ,Guaifenesin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47b54126-be68-dc81-e063-6294a90aaf7c", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ"], "rxcui": ["2377385"], "spl_set_id": ["353ef34f-760d-ae92-e063-6294a90a5b4a"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Softgel Healthcare Pvt Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0184-2)", "package_ndc": "35916-0184-2", "marketing_start_date": "20250517"}, {"sample": false, "description": "2 POUCH in 1 BOX (35916-0184-3)  / 2000 CAPSULE, LIQUID FILLED in 1 POUCH", "package_ndc": "35916-0184-3", "marketing_start_date": "20250925"}, {"sample": false, "description": "2 BAG in 1 BOX (35916-0184-4)  / 1500 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "35916-0184-4", "marketing_start_date": "20260116"}], "brand_name": "Acetaminophen, Dextromethorphan HBr ,Guaifenesin", "product_id": "35916-0184_47b54126-be68-dc81-e063-6294a90aaf7c", "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": "35916-0184", "generic_name": "Acetaminophen, Dextromethorphan HBr ,Guaifenesin", "labeler_name": "Softgel Healthcare Pvt Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen, Dextromethorphan HBr ,Guaifenesin", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250517", "listing_expiration_date": "20271231"}