poly hist forte

Generic: doxylamine succinate and phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name poly hist forte
Generic Name doxylamine succinate and phenylephrine hydrochloride
Labeler poly pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxylamine succinate 10.5 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Poly Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50991-626
Product ID 50991-626_1cda46d8-607e-048a-e063-6394a90a6d65
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50991626
Hyphenated Format 50991-626

Supplemental Identifiers

RxCUI
2172491
UNII
V9BI9B5YI2 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 poly hist forte (source: ndc)
Generic Name doxylamine succinate and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10.5 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (50991-626-01)
  • 12 BLISTER PACK in 1 CARTON (50991-626-02) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

50991-626-01 100 TABLET in 1 BOTTLE (50991-626-01) 50991-626-02 12 BLISTER PACK in 1 CARTON (50991-626-02) / 1 TABLET in 1 BLISTER PACK

Ingredients (2)

doxylamine succinate (10.5 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Poly Hist Forte ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1cda46d8-607e-048a-e063-6394a90a6d65", "openfda": {"unii": ["V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["2172491"], "spl_set_id": ["8aa0015b-8fc1-7951-e053-2a95a90a8e72"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (50991-626-01)", "package_ndc": "50991-626-01", "marketing_start_date": "20190601"}, {"sample": false, "description": "12 BLISTER PACK in 1 CARTON (50991-626-02)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "50991-626-02", "marketing_start_date": "20190601"}], "brand_name": "Poly Hist Forte", "product_id": "50991-626_1cda46d8-607e-048a-e063-6394a90a6d65", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "50991-626", "generic_name": "Doxylamine Succinate and Phenylephrine Hydrochloride", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Poly Hist Forte", "active_ingredients": [{"name": "DOXYLAMINE SUCCINATE", "strength": "10.5 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190601", "listing_expiration_date": "20261231"}