giltuss d

Generic: giltuss d

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

Drug Facts

Product Profile

Brand Name giltuss d
Generic Name giltuss d
Labeler dextrum laboratories inc.
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

chlorpheniramine maleate 3.5 mg/10mL, phenylephrine hydrochloride 10 mg/10mL

Manufacturer
Dextrum Laboratories Inc.

Identifiers & Regulatory

Product NDC 65852-010
Product ID 65852-010_3f17eefb-b626-b0f2-e063-6294a90afd4d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-04-11

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65852010
Hyphenated Format 65852-010

Supplemental Identifiers

RxCUI
2724415
UNII
V1Q0O9OJ9Z 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 d (source: ndc)
Generic Name giltuss d (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/10mL
  • 10 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (65852-010-04) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

65852-010-04 1 BOTTLE, PLASTIC in 1 CARTON (65852-010-04) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

chlorpheniramine maleate (3.5 mg/10mL) phenylephrine hydrochloride (10 mg/10mL)

Linked Drug Pages (1)

Giltuss D ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f17eefb-b626-b0f2-e063-6294a90afd4d", "openfda": {"unii": ["V1Q0O9OJ9Z", "04JA59TNSJ"], "rxcui": ["2724415"], "spl_set_id": ["3f17eefb-b625-b0f2-e063-6294a90afd4d"], "manufacturer_name": ["Dextrum Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (65852-010-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "65852-010-04", "marketing_start_date": "20240411"}], "brand_name": "Giltuss D", "product_id": "65852-010_3f17eefb-b626-b0f2-e063-6294a90afd4d", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "65852-010", "generic_name": "Giltuss D", "labeler_name": "Dextrum Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss D", "active_ingredients": [{"name": "CHLORPHENIRAMINE MALEATE", "strength": "3.5 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240411", "listing_expiration_date": "20261231"}