endal

Generic: triprolidine hcl, dextromethorphan hbr

Labeler: poly pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name endal
Generic Name triprolidine hcl, dextromethorphan hbr
Labeler poly pharmaceuticals, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/5mL, triprolidine hydrochloride 1.25 mg/5mL

Manufacturer
Poly Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50991-136
Product ID 50991-136_42678322-4335-74c0-e063-6394a90a77cb
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-05-22

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 50991136
Hyphenated Format 50991-136

Supplemental Identifiers

RxCUI
2637485
UPC
0350991136166
UNII
9D2RTI9KYH YAN7R5L890

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 endal (source: ndc)
Generic Name triprolidine hcl, dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 1.25 mg/5mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE (50991-136-05)
  • 15 mL in 1 BOTTLE (50991-136-15)
  • 473 mL in 1 BOTTLE (50991-136-16)
source: ndc

Packages (3)

50991-136-05 5 mL in 1 BOTTLE (50991-136-05) 50991-136-15 15 mL in 1 BOTTLE (50991-136-15) 50991-136-16 473 mL in 1 BOTTLE (50991-136-16)

Ingredients (2)

dextromethorphan hydrobromide (10 mg/5mL) triprolidine hydrochloride (1.25 mg/5mL)

Linked Drug Pages (1)

Endal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42678322-4335-74c0-e063-6394a90a77cb", "openfda": {"upc": ["0350991136166"], "unii": ["9D2RTI9KYH", "YAN7R5L890"], "rxcui": ["2637485"], "spl_set_id": ["fc5401e2-ed65-72e7-e053-6294a90a81f3"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE (50991-136-05)", "package_ndc": "50991-136-05", "marketing_start_date": "20251029"}, {"sample": false, "description": "15 mL in 1 BOTTLE (50991-136-15)", "package_ndc": "50991-136-15", "marketing_start_date": "20230522"}, {"sample": false, "description": "473 mL in 1 BOTTLE (50991-136-16)", "package_ndc": "50991-136-16", "marketing_start_date": "20230522"}], "brand_name": "Endal", "product_id": "50991-136_42678322-4335-74c0-e063-6394a90a77cb", "dosage_form": "LIQUID", "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": "50991-136", "generic_name": "Triprolidine HCl, Dextromethorphan HBr", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Endal", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "TRIPROLIDINE HYDROCHLORIDE", "strength": "1.25 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230522", "listing_expiration_date": "20261231"}