delsym

Generic: dextromethorphan

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

Drug Facts

Product Profile

Brand Name delsym
Generic Name dextromethorphan
Labeler rb health (us) llc
Dosage Form SUSPENSION, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dextromethorphan 30 mg/5mL

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-175
Product ID 63824-175_6636ee1b-6c5c-4a0f-8c96-d0f94b0e84fa
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 63824175
Hyphenated Format 63824-175

Supplemental Identifiers

RxCUI
1373045 1373128
UNII
7355X3ROTS
NUI
N0000181821 N0000182149 N0000181819 N0000182147

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 (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
  • 2 CARTON in 1 CELLO PACK (63824-175-22) / 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (63824-175-63) / 89 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (63824-175-65) / 148 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (63824-175-75) / 15 mL in 1 BOTTLE
source: ndc

Packages (4)

63824-175-22 2 CARTON in 1 CELLO PACK (63824-175-22) / 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE 63824-175-63 1 BOTTLE in 1 CARTON (63824-175-63) / 89 mL in 1 BOTTLE 63824-175-65 1 BOTTLE in 1 CARTON (63824-175-65) / 148 mL in 1 BOTTLE 63824-175-75 1 BOTTLE in 1 CARTON (63824-175-75) / 15 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": "6636ee1b-6c5c-4a0f-8c96-d0f94b0e84fa", "openfda": {"nui": ["N0000181821", "N0000182149", "N0000181819", "N0000182147"], "unii": ["7355X3ROTS"], "rxcui": ["1373045", "1373128"], "spl_set_id": ["e3e1d126-76c2-4776-8ce0-449625b7e6ba"], "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": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CARTON in 1 CELLO PACK (63824-175-22)  / 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE", "package_ndc": "63824-175-22", "marketing_start_date": "20100504"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (63824-175-63)  / 89 mL in 1 BOTTLE", "package_ndc": "63824-175-63", "marketing_start_date": "20100504"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (63824-175-65)  / 148 mL in 1 BOTTLE", "package_ndc": "63824-175-65", "marketing_start_date": "20100504"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (63824-175-75)  / 15 mL in 1 BOTTLE", "package_ndc": "63824-175-75", "marketing_start_date": "20100504"}], "brand_name": "Delsym", "product_id": "63824-175_6636ee1b-6c5c-4a0f-8c96-d0f94b0e84fa", "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": "63824-175", "generic_name": "Dextromethorphan", "labeler_name": "RB Health (US) LLC", "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"}