NDC 55758-142 Sanatos Day And Night Multi Symptom

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate Kit Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
55758-142
Proprietary Name:
Sanatos Day And Night Multi Symptom
Non-Proprietary Name: [1]
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Pharmadel
    Labeler Code:
    55758
    FDA Application Number: [6]
    part341
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    09-30-2018
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    ORANGE (C48331 - LIQUICAP)
    GREEN (C48329 - LIQUICAP)
    Shape:
    OVAL (C48345)
    Size(s):
    21 MM

    Product Packages

    NDC Code 55758-142-24

    Package Description: 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

    Product Details

    What is NDC 55758-142?

    The NDC code 55758-142 is assigned by the FDA to the product Sanatos Day And Night Multi Symptom which is a human over the counter drug product labeled by Pharmadel. The generic name of Sanatos Day And Night Multi Symptom is acetaminophen, dextromethorphan hbr, doxylamine succinate. The product's dosage form is kit and is administered via oral form. The product is distributed in a single package with assigned NDC code 55758-142-24 1 blister pack in 1 carton / 1 kit in 1 blister pack * 1 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack * 1 blister pack in 1 carton / 12 capsule, liquid filled 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 Sanatos Day And Night Multi Symptom?

    Daytime & Nighttimetake only as directeddo not exceed 4 doses in a 24-hour periodeven if taking both Daytime and Nighttime, total limit per day is 4 doses per 24 hour periodadults & children 12 years & over: take two (2) liquicaps with water every 4 hourschildren 4 to under 12 years consult a doctorchildren under 4 years: do not use

    Which are Sanatos Day And Night Multi Symptom UNII Codes?

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

    Which are Sanatos Day And Night Multi Symptom 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 Sanatos Day And Night Multi Symptom?

    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: 1086997 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
    • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
    • RxCUI: 1086997 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
    • RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule
    • RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule

    * 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.

    [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".