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  4. NDC Product Code: 50991-626 Poly Hist Forte

NDC 50991-626 Poly Hist Forte

Doxylamine Succinate And Phenylephrine Hydrochloride Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50991-626?
  5. Poly Hist Forte Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
50991-626
Proprietary Name:
Poly Hist Forte
Non-Proprietary Name: [1]
Doxylamine Succinate And Phenylephrine Hydrochloride
Substance Name: [2]
Doxylamine Succinate; Phenylephrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Poly Pharmaceuticals, Inc.
    Labeler Code:
    50991
    Product Label ID:
    8aa0015b-8fc1-7951-e053-2a95a90a8e72
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    06-01-2019
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333)
    Shape:
    CAPSULE (C48336)
    Size(s):
    14 MM
    Imprint(s):
    POLY;216
    Score:
    2

    Product Packages

    NDC Code 50991-626-01

    Package Description: 100 TABLET in 1 BOTTLE

    Price per Unit: $0.65945 per EA

    NDC Code 50991-626-02

    Package Description: 12 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK

    Product Details

    What is NDC 50991-626?

    The NDC code 50991-626 is assigned by the FDA to the product Poly Hist Forte which is a human over the counter drug product labeled by Poly Pharmaceuticals, Inc.. The generic name of Poly Hist Forte is doxylamine succinate and phenylephrine hydrochloride. The product's dosage form is tablet and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 50991-626-01 100 tablet in 1 bottle , 50991-626-02 12 blister pack in 1 carton / 1 tablet in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Poly Hist Forte?

    Do not exceed recommended dosage. Adults and children 12 years of age and over 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.  Children 6 to 12 years of age:  1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours.  Children 6 years       of age and younger:        Consult a physician.

    What are Poly Hist Forte Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Poly Hist Forte UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Poly Hist Forte Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Poly Hist Forte?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 2172491 - doxylamine succinate 10.5 MG / phenylephrine HCl 10 MG Oral Tablet
    • RxCUI: 2172491 - doxylamine succinate 10.5 MG / phenylephrine hydrochloride 10 MG Oral Tablet

    Which are the Pharmacologic Classes for Poly Hist Forte?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Doxylamine


    Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
    [Learn More]


    Phenylephrine


    Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".