delsym cough plus sore throat

Generic: acetaminophen and dextromethorphan hydrobromide

Labeler: rb health (us) llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name delsym cough plus sore throat
Generic Name acetaminophen and dextromethorphan hydrobromide
Labeler rb health (us) llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/20mL, dextromethorphan hydrobromide 20 mg/20mL

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-221
Product ID 63824-221_4b84fa17-1087-9ff4-e063-6394a90aea7c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2019-07-01

Pharmacologic Class

Classes
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 63824221
Hyphenated Format 63824-221

Supplemental Identifiers

RxCUI
1919076
UPC
0363824819914
UNII
362O9ITL9D 9D2RTI9KYH

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 delsym cough plus sore throat (source: ndc)
Generic Name acetaminophen and dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/20mL
  • 20 mg/20mL
source: ndc
Packaging
  • 180 mL in 1 BOTTLE (63824-221-66)
source: ndc

Packages (1)

63824-221-66 180 mL in 1 BOTTLE (63824-221-66)

Ingredients (2)

acetaminophen (650 mg/20mL) dextromethorphan hydrobromide (20 mg/20mL)

Linked Drug Pages (1)

Delsym Cough Plus Sore Throat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b84fa17-1087-9ff4-e063-6394a90aea7c", "openfda": {"upc": ["0363824819914"], "unii": ["362O9ITL9D", "9D2RTI9KYH"], "rxcui": ["1919076"], "spl_set_id": ["b37b786e-0cce-419d-94ed-3b64a1eb1201"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 mL in 1 BOTTLE (63824-221-66)", "package_ndc": "63824-221-66", "marketing_start_date": "20190701"}], "brand_name": "Delsym Cough Plus Sore Throat", "product_id": "63824-221_4b84fa17-1087-9ff4-e063-6394a90aea7c", "dosage_form": "SOLUTION", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "63824-221", "generic_name": "Acetaminophen and Dextromethorphan Hydrobromide", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Delsym", "brand_name_suffix": "Cough Plus Sore Throat", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190701", "listing_expiration_date": "20271231"}