giltuss allergy plus

Generic: chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride

Labeler: dextrum laboratories inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name giltuss allergy plus
Generic Name chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
Labeler dextrum laboratories inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

chlorpheniramine maleate 4 mg/10mL, dextromethorphan hydrobromide 20 mg/10mL, phenylephrine hydrochloride 10 mg/10mL

Manufacturer
Dextrum Laboratories Inc.

Identifiers & Regulatory

Product NDC 65852-017
Product ID 65852-017_3fa0b3be-2125-ed1d-e063-6294a90aaf48
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-10-02

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 65852017
Hyphenated Format 65852-017

Supplemental Identifiers

RxCUI
1363752
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 giltuss allergy plus (source: ndc)
Generic Name chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/10mL
  • 20 mg/10mL
  • 10 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (65852-017-04) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

65852-017-04 1 BOTTLE, PLASTIC in 1 CARTON (65852-017-04) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (3)

chlorpheniramine maleate (4 mg/10mL) dextromethorphan hydrobromide (20 mg/10mL) phenylephrine hydrochloride (10 mg/10mL)

Linked Drug Pages (1)

Giltuss Allergy Plus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3fa0b3be-2125-ed1d-e063-6294a90aaf48", "openfda": {"unii": ["V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1363752"], "spl_set_id": ["3fa0b3be-2124-ed1d-e063-6294a90aaf48"], "manufacturer_name": ["Dextrum Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (65852-017-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "65852-017-04", "marketing_start_date": "20181002"}], "brand_name": "Giltuss Allergy Plus", "product_id": "65852-017_3fa0b3be-2125-ed1d-e063-6294a90aaf48", "dosage_form": "SOLUTION", "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": "65852-017", "generic_name": "CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Dextrum Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss Allergy Plus", "active_ingredients": [{"name": "CHLORPHENIRAMINE MALEATE", "strength": "4 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20181002", "listing_expiration_date": "20261231"}