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  4. NDC Product Code: 63868-393 Unisom Sleepmelts Nighttime Sleep-aid

NDC 63868-393 Unisom Sleepmelts Nighttime Sleep-aid

Diphenhydramine Hydrochloride Tablet, Chewable Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 63868-393?
  5. Unisom Sleepmelts Nighttime Sleep-aid Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
63868-393
Proprietary Name:
Unisom Sleepmelts Nighttime Sleep-aid
Non-Proprietary Name: [1]
Diphenhydramine Hydrochloride
Substance Name: [2]
Diphenhydramine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Quality Choice (chain Drug Marketing Association)
    Labeler Code:
    63868
    Product Label ID:
    f50cc038-0973-4c4b-84a7-1c68f41c2410
    FDA Application Number: [6]
    M010
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    01-07-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328)
    Shape:
    ROUND (C48348)
    Size(s):
    13 MM
    Imprint(s):
    U
    Score:
    1
    Flavor(s):
    CHERRY (C73375)

    Code Structure Chart

    Product Details

    What is NDC 63868-393?

    The NDC code 63868-393 is assigned by the FDA to the product Unisom Sleepmelts Nighttime Sleep-aid which is a human over the counter drug product labeled by Quality Choice (chain Drug Marketing Association). The generic name of Unisom Sleepmelts Nighttime Sleep-aid is diphenhydramine hydrochloride. The product's dosage form is tablet, chewable and is administered via oral form. The product is distributed in a single package with assigned NDC code 63868-393-24 24 tablet, chewable 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 Unisom Sleepmelts Nighttime Sleep-aid?

    •adults and children 12 years of age and over: 2 tablets (25 mg each) at bedtime if needed, or as directed by a doctor•place 2 tablets on tongue; tablets dissolve with or without water•allow tablets to dissolve in mouth or chew before swallowing

    What are Unisom Sleepmelts Nighttime Sleep-aid 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.
    • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 - A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.

    Which are Unisom Sleepmelts Nighttime Sleep-aid UNII Codes?

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

    • DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
    • DIPHENHYDRAMINE (UNII: 8GTS82S83M) (Active Moiety)

    Which are Unisom Sleepmelts Nighttime Sleep-aid 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 Unisom Sleepmelts Nighttime Sleep-aid?

    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: 1093098 - diphenhydrAMINE HCl 25 MG Disintegrating Oral Tablet
    • RxCUI: 1093098 - diphenhydramine hydrochloride 25 MG Disintegrating Oral Tablet
    • RxCUI: 1093102 - Unisom SleepMelts 25 MG Disintegrating Oral Tablet
    • RxCUI: 1093102 - diphenhydramine hydrochloride 25 MG Disintegrating Oral Tablet [Unisom Sleep]
    • RxCUI: 1093102 - Unisom Sleep 25 MG Disintegrating Oral Tablet

    Which are the Pharmacologic Classes for Unisom Sleepmelts Nighttime Sleep-aid?

    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.

    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.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [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".