acetaminophen 325mg, dextromethorphan hbr 10mg and phenyleprine hcl 5mg

Generic: acetaminophen, dextromethorphan hbr and phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name acetaminophen 325mg, dextromethorphan hbr 10mg and phenyleprine hcl 5mg
Generic Name acetaminophen, dextromethorphan hbr and phenylephrine hcl
Labeler softgel healthcare private limited
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

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

Manufacturer
Softgel Healthcare Private Limited

Identifiers & Regulatory

Product NDC 35916-0188
Product ID 35916-0188_47c9947c-e568-9de2-e063-6294a90adcff
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

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 359160188
Hyphenated Format 35916-0188

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 325mg, dextromethorphan hbr 10mg and phenyleprine hcl 5mg (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr and phenylephrine hcl (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
  • 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0188-1)
  • 2 POUCH in 1 BOX (35916-0188-2) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH
  • 2 POUCH in 1 BOX (35916-0188-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH
  • 2 BAG in 1 BOX (35916-0188-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (4)

35916-0188-1 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0188-1) 35916-0188-2 2 POUCH in 1 BOX (35916-0188-2) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH 35916-0188-3 2 POUCH in 1 BOX (35916-0188-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH 35916-0188-4 2 BAG in 1 BOX (35916-0188-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (3)

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

Linked Drug Pages (1)

Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47c9947c-e568-9de2-e063-6294a90adcff", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086997"], "spl_set_id": ["30ab39f3-27cc-5728-e063-6394a90a9cbe"], "manufacturer_name": ["Softgel Healthcare Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0188-1)", "package_ndc": "35916-0188-1", "marketing_start_date": "20250321"}, {"sample": false, "description": "2 POUCH in 1 BOX (35916-0188-2)  / 3000 CAPSULE, LIQUID FILLED in 1 POUCH", "package_ndc": "35916-0188-2", "marketing_start_date": "20250612"}, {"sample": false, "description": "2 POUCH in 1 BOX (35916-0188-3)  / 2000 CAPSULE, LIQUID FILLED in 1 POUCH", "package_ndc": "35916-0188-3", "marketing_start_date": "20250925"}, {"sample": false, "description": "2 BAG in 1 BOX (35916-0188-4)  / 1500 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "35916-0188-4", "marketing_start_date": "20260113"}], "brand_name": "Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg", "product_id": "35916-0188_47c9947c-e568-9de2-e063-6294a90adcff", "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": "35916-0188", "generic_name": "Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl", "labeler_name": "Softgel Healthcare Private Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg", "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": "20250321", "listing_expiration_date": "20271231"}