acetaminophen, dextromethorphan hbr and doxylamine succinate

Generic: acetaminophen, dextromethorphan hbr and doxylamine succinate

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

Drug Facts

Product Profile

Brand Name acetaminophen, dextromethorphan hbr and doxylamine succinate
Generic Name acetaminophen, dextromethorphan hbr and doxylamine succinate
Labeler softgel healthcare private limited
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

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

Manufacturer
Softgel Healthcare Private Limited

Identifiers & Regulatory

Product NDC 35916-0185
Product ID 35916-0185_47ed4b1e-f714-606e-e063-6394a90a0a73
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

Classes
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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 359160185
Hyphenated Format 35916-0185

Supplemental Identifiers

RxCUI
1426334
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2

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 and doxylamine succinate (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr and doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0185-2)
  • 2 POUCH in 1 BOX (35916-0185-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH
  • 2 BAG in 1 BOX (35916-0185-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (3)

35916-0185-2 3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0185-2) 35916-0185-3 2 POUCH in 1 BOX (35916-0185-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH 35916-0185-4 2 BAG in 1 BOX (35916-0185-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (3)

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

Linked Drug Pages (1)

Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47ed4b1e-f714-606e-e063-6394a90a0a73", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1426334"], "spl_set_id": ["353f71f7-81e0-08c2-e063-6294a90acb49"], "manufacturer_name": ["Softgel Healthcare Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0185-2)", "package_ndc": "35916-0185-2", "marketing_start_date": "20250517"}, {"sample": false, "description": "2 POUCH in 1 BOX (35916-0185-3)  / 2000 CAPSULE, LIQUID FILLED in 1 POUCH", "package_ndc": "35916-0185-3", "marketing_start_date": "20250925"}, {"sample": false, "description": "2 BAG in 1 BOX (35916-0185-4)  / 1500 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "35916-0185-4", "marketing_start_date": "20260116"}], "brand_name": "Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate", "product_id": "35916-0185_47ed4b1e-f714-606e-e063-6394a90a0a73", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["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]"], "product_ndc": "35916-0185", "generic_name": "Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate", "labeler_name": "Softgel Healthcare Private Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250517", "listing_expiration_date": "20271231"}