acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl

Generic: acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl

Labeler: opmx llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl
Generic Name acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl
Labeler opmx llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
OPMX LLC

Identifiers & Regulatory

Product NDC 69729-782
Product ID 69729-782_18adbc15-b127-cc7e-e063-6394a90a1e9c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-02-18

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 69729782
Hyphenated Format 69729-782

Supplemental Identifiers

RxCUI
1656815
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
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, guaifenesin, dextromethorphan hbr, phenylephrine hcl (source: ndc)
Generic Name acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 200 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69729-782-10)
source: ndc

Packages (1)

69729-782-10 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69729-782-10)

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "18adbc15-b127-cc7e-e063-6394a90a1e9c", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1656815"], "spl_set_id": ["9a164cfc-b623-9a9f-e053-2a95a90a0173"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["OPMX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69729-782-10)", "package_ndc": "69729-782-10", "marketing_start_date": "20190218"}], "brand_name": "Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl", "product_id": "69729-782_18adbc15-b127-cc7e-e063-6394a90a1e9c", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "69729-782", "generic_name": "Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl", "labeler_name": "OPMX LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190218", "listing_expiration_date": "20261231"}