giltuss dm

Generic: dextromethorphan hbr

Labeler: gil pharmaceutical corp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name giltuss dm
Generic Name dextromethorphan hbr
Labeler gil pharmaceutical corp
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 30 mg/10mL

Manufacturer
Gil Pharmaceutical Corp

Identifiers & Regulatory

Product NDC 58552-150
Product ID 58552-150_40b96169-c482-7688-e063-6294a90a154c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-06-27

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 58552150
Hyphenated Format 58552-150

Supplemental Identifiers

RxCUI
1090496
UNII
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 giltuss dm (source: ndc)
Generic Name dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58552-150-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

58552-150-04 1 BOTTLE in 1 CARTON (58552-150-04) / 118 mL in 1 BOTTLE

Ingredients (1)

dextromethorphan hydrobromide (30 mg/10mL)

Linked Drug Pages (1)

Giltuss DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40b96169-c482-7688-e063-6294a90a154c", "openfda": {"unii": ["9D2RTI9KYH"], "rxcui": ["1090496"], "spl_set_id": ["1a4fe686-3085-4543-bd6c-f20580b1df50"], "manufacturer_name": ["Gil Pharmaceutical Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58552-150-04)  / 118 mL in 1 BOTTLE", "package_ndc": "58552-150-04", "marketing_start_date": "20230809"}], "brand_name": "Giltuss DM", "product_id": "58552-150_40b96169-c482-7688-e063-6294a90a154c", "dosage_form": "SYRUP", "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": "58552-150", "generic_name": "Dextromethorphan HBR", "labeler_name": "Gil Pharmaceutical Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230627", "listing_expiration_date": "20261231"}