acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride

Generic: acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride
Generic Name acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride
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 35916-0917
Product ID 35916-0917_47c778d0-4d3a-074a-e063-6394a90a670c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2025-06-19

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 359160917
Hyphenated Format 35916-0917

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, dextromethorphan hydrobromide and phenylephrine hydrochloride (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide and 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
  • 2 POUCH in 1 CARTON (35916-0917-1) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH
source: ndc

Packages (1)

35916-0917-1 2 POUCH in 1 CARTON (35916-0917-1) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH

Ingredients (3)

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

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47c778d0-4d3a-074a-e063-6394a90a670c", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086997"], "spl_set_id": ["37e8ccd5-6be1-9aca-e063-6394a90a5263"], "manufacturer_name": ["SOFTGEL HEALTHCARE PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 POUCH in 1 CARTON (35916-0917-1)  / 3000 CAPSULE, LIQUID FILLED in 1 POUCH", "package_ndc": "35916-0917-1", "marketing_start_date": "20250619"}], "brand_name": "Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride", "product_id": "35916-0917_47c778d0-4d3a-074a-e063-6394a90a670c", "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": "35916-0917", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride", "labeler_name": "SOFTGEL HEALTHCARE PRIVATE LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride", "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": "20250619", "listing_expiration_date": "20271231"}