acetaminophen 325 mg, dextromethorphan hydrobromide 10 mg, phenlyephrine hydrochloride 5 mg softgel (day-time)

Generic: acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

Labeler: health pharma usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen 325 mg, dextromethorphan hydrobromide 10 mg, phenlyephrine hydrochloride 5 mg softgel (day-time)
Generic Name acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
Labeler health pharma usa llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

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

Manufacturer
Health Pharma USA LLC

Identifiers & Regulatory

Product NDC 71679-101
Product ID 71679-101_3f86a539-828a-a6d3-e063-6294a90ab8c2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-09-24

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] 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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71679101
Hyphenated Format 71679-101

Supplemental Identifiers

RxCUI
1086997
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ

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 325 mg, dextromethorphan hydrobromide 10 mg, phenlyephrine hydrochloride 5 mg softgel (day-time) (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 3000 CAPSULE, LIQUID FILLED in 1 DRUM (71679-101-00)
source: ndc

Packages (1)

71679-101-00 3000 CAPSULE, LIQUID FILLED in 1 DRUM (71679-101-00)

Ingredients (3)

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

Linked Drug Pages (1)

Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f86a539-828a-a6d3-e063-6294a90ab8c2", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086997"], "spl_set_id": ["a03befb4-d86d-43e4-8097-eda5c8bb25be"], "manufacturer_name": ["Health Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3000 CAPSULE, LIQUID FILLED in 1 DRUM (71679-101-00)", "package_ndc": "71679-101-00", "marketing_start_date": "20250924"}], "brand_name": "Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)", "product_id": "71679-101_3f86a539-828a-a6d3-e063-6294a90ab8c2", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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": "71679-101", "generic_name": "acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride", "labeler_name": "Health Pharma USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250924", "listing_expiration_date": "20261231"}