delsym

Generic: dextromethorphan

Labeler: a-s medication solutions
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name delsym
Generic Name dextromethorphan
Labeler a-s medication solutions
Dosage Form SUSPENSION, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dextromethorphan 30 mg/5mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-0224
Product ID 50090-0224_018b0d50-2f6c-447a-a3bc-f43f639834b1
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA018658
Listing Expiration 2026-12-31
Marketing Start 2010-05-04

Pharmacologic Class

Established (EPC)
uncompetitive n-methyl-d-aspartate receptor antagonist [epc] sigma-1 agonist [epc]
Mechanism of Action
uncompetitive nmda receptor antagonists [moa] sigma-1 receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500900224
Hyphenated Format 50090-0224

Supplemental Identifiers

RxCUI
1373045 1373128
UNII
7355X3ROTS
NUI
N0000181821 N0000182149 N0000181819 N0000182147

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 (source: ndc)
Generic Name dextromethorphan (source: ndc)
Application Number NDA018658 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50090-0224-0) / 89 mL in 1 BOTTLE
source: ndc

Packages (1)

50090-0224-0 1 BOTTLE in 1 CARTON (50090-0224-0) / 89 mL in 1 BOTTLE

Ingredients (1)

dextromethorphan (30 mg/5mL)

Linked Drug Pages (1)

DELSYM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "018b0d50-2f6c-447a-a3bc-f43f639834b1", "openfda": {"nui": ["N0000181821", "N0000182149", "N0000181819", "N0000182147"], "unii": ["7355X3ROTS"], "rxcui": ["1373045", "1373128"], "spl_set_id": ["2ac3cac7-5980-4ff5-9939-d494c3daa9d2"], "pharm_class_epc": ["Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]"], "pharm_class_moa": ["Uncompetitive NMDA Receptor Antagonists [MoA]", "Sigma-1 Receptor Agonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50090-0224-0)  / 89 mL in 1 BOTTLE", "package_ndc": "50090-0224-0", "marketing_start_date": "20141128"}], "brand_name": "DELSYM", "product_id": "50090-0224_018b0d50-2f6c-447a-a3bc-f43f639834b1", "dosage_form": "SUSPENSION, EXTENDED RELEASE", "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": "50090-0224", "generic_name": "Dextromethorphan", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DELSYM", "active_ingredients": [{"name": "DEXTROMETHORPHAN", "strength": "30 mg/5mL"}], "application_number": "NDA018658", "marketing_category": "NDA", "marketing_start_date": "20100504", "listing_expiration_date": "20261231"}