acetaminophen, dextromethorphan hydrobromide, doxylamine succinate and phenylephrine hydrochloride

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate and phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate and phenylephrine hydrochloride
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate and phenylephrine hydrochloride
Labeler softgel healthcare pvt ltd
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, doxylamine succinate 6.25 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Softgel Healthcare Pvt Ltd

Identifiers & Regulatory

Product NDC 35916-0186
Product ID 35916-0186_47f1ead9-f77c-b88d-e063-6394a90af9bf
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2025-06-11

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] antihistamine [epc] histamine receptor antagonists [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 359160186
Hyphenated Format 35916-0186

Supplemental Identifiers

RxCUI
1297288
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2 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, dextromethorphan hydrobromide, doxylamine succinate and phenylephrine hydrochloride (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 6.25 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 POUCH in 1 BOX (35916-0186-1) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH
  • 2 POUCH in 1 BOX (35916-0186-2) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH
  • 2 BAG in 1 BOX (35916-0186-3) / 1500 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (3)

35916-0186-1 2 POUCH in 1 BOX (35916-0186-1) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH 35916-0186-2 2 POUCH in 1 BOX (35916-0186-2) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH 35916-0186-3 2 BAG in 1 BOX (35916-0186-3) / 1500 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) doxylamine succinate (6.25 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47f1ead9-f77c-b88d-e063-6394a90af9bf", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["1297288"], "spl_set_id": ["36ced59c-12dc-441f-e063-6294a90a3239"], "manufacturer_name": ["Softgel Healthcare Pvt Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 POUCH in 1 BOX (35916-0186-1)  / 3000 CAPSULE, LIQUID FILLED in 1 POUCH", "package_ndc": "35916-0186-1", "marketing_start_date": "20250611"}, {"sample": false, "description": "2 POUCH in 1 BOX (35916-0186-2)  / 2000 CAPSULE, LIQUID FILLED in 1 POUCH", "package_ndc": "35916-0186-2", "marketing_start_date": "20250925"}, {"sample": false, "description": "2 BAG in 1 BOX (35916-0186-3)  / 1500 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "35916-0186-3", "marketing_start_date": "20260112"}], "brand_name": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride", "product_id": "35916-0186_47f1ead9-f77c-b88d-e063-6394a90af9bf", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Antihistamine [EPC]", "Histamine Receptor Antagonists [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": "35916-0186", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride", "labeler_name": "Softgel Healthcare Pvt Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250611", "listing_expiration_date": "20271231"}