1. Home
  2. Labeler Index
  3. Hyland's Inc.
  4. NDC Product Code: 54973-3158 Tiny Cold

NDC 54973-3158 Tiny Cold

Eupatorium Perfoliatum Flowering Top,Euphrasia Stricta,Gelsemium Sempervirens Root,And - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 54973-3158?
  4. Tiny Cold Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
54973-3158
Proprietary Name:
Tiny Cold
Non-Proprietary Name: [1]
Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodide
Substance Name: [2]
Eupatorium Perfoliatum Flowering Top; Euphrasia Stricta; Gelsemium Sempervirens Root; Potassium Iodide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Soluble - A solid dosage form that contains medicinal substances with or without suitable diluents and possesses the ability to dissolve in fluids.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Hyland's Inc.
    Labeler Code:
    54973
    Product Label ID:
    be7cff09-ecff-48bd-96d4-dc7d47db7656
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    12-28-2011
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 54973-3158-1

    Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 125 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 54973-3158?

    The NDC code 54973-3158 is assigned by the FDA to the product Tiny Cold which is a human over the counter drug product labeled by Hyland's Inc.. The generic name of Tiny Cold is eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide. The product's dosage form is tablet, soluble and is administered via oral form. The product is distributed in a single package with assigned NDC code 54973-3158-1 1 bottle, plastic in 1 carton / 125 tablet, soluble in 1 bottle, plastic. 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 Tiny Cold?

    Children under 6 months of age: consult a licensed health care professional before using this product.Children 6 months to 1 year of age: dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.Children 1 to 3 years of age: dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.Hyland's Baby Tiny Cold Tablets are very soft and will dissolve almost instantly in the mouth. Children under 6 months of age: consult a licensed health care professional before using this product.Children 6 months to 1 year of age: dissolve 2 tablets on tongue every 4 hours during the night as required.Children 1 to 3 years of age: dissolve 3 tablets on tongue every 4 hours during the night as required.Hyland's Baby Nighttime Tiny Cold Tablets are very soft and will dissolve almost instantly in the mouth.

    What are Tiny Cold 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 Tiny Cold UNII Codes?

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

    • EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E)
    • EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (Active Moiety)
    • EUPHRASIA STRICTA (UNII: C9642I91WL)
    • EUPHRASIA STRICTA (UNII: C9642I91WL) (Active Moiety)
    • GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q)
    • GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (Active Moiety)
    • POTASSIUM IODIDE (UNII: 1C4QK22F9J)
    • IODIDE ION (UNII: 09G4I6V86Q) (Active Moiety)
    • MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
    • MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (Active Moiety)

    Which are Tiny Cold 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:

    * 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".