ed a-hist dm

Generic: dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name ed a-hist dm
Generic Name dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride
Labeler edwards pharmaceuticals, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

chlorpheniramine maleate 4 mg/5mL, dextromethorphan hydrobromide 15 mg/5mL, phenylephrine hydrochloride 10 mg/5mL

Manufacturer
EDWARDS PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 0485-0171
Product ID 0485-0171_4742a150-3418-b7c6-e063-6294a90adcda
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2012-09-11

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04850171
Hyphenated Format 0485-0171

Supplemental Identifiers

RxCUI
1086443
UPC
0304850171164
UNII
V1Q0O9OJ9Z 9D2RTI9KYH 04JA59TNSJ

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 ed a-hist dm (source: ndc)
Generic Name dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
  • 15 mg/5mL
  • 10 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (0485-0171-16)
source: ndc

Packages (1)

0485-0171-16 473 mL in 1 BOTTLE, PLASTIC (0485-0171-16)

Ingredients (3)

chlorpheniramine maleate (4 mg/5mL) dextromethorphan hydrobromide (15 mg/5mL) phenylephrine hydrochloride (10 mg/5mL)

Linked Drug Pages (1)

ED A-HIST DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4742a150-3418-b7c6-e063-6294a90adcda", "openfda": {"upc": ["0304850171164"], "unii": ["V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086443"], "spl_set_id": ["e0e2b117-62bc-4132-9f7c-fe2a912052b1"], "manufacturer_name": ["EDWARDS PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (0485-0171-16)", "package_ndc": "0485-0171-16", "marketing_start_date": "20120911"}], "brand_name": "ED A-HIST DM", "product_id": "0485-0171_4742a150-3418-b7c6-e063-6294a90adcda", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0485-0171", "generic_name": "DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "EDWARDS PHARMACEUTICALS, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ED A-HIST DM", "active_ingredients": [{"name": "CHLORPHENIRAMINE MALEATE", "strength": "4 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120911", "listing_expiration_date": "20261231"}