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NDC 41250-031 Nitetime Cough Daytime Cough

Dextromethorphan Hydrobromide,Doxylamine Succinate Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 41250-031?
  5. Nitetime Cough Daytime Cough Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
41250-031
Proprietary Name:
Nitetime Cough Daytime Cough
Non-Proprietary Name: [1]
Dextromethorphan Hydrobromide, 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.
Labeler Name: [5]
Meijer Distribution Inc
Labeler Code:
41250
Product Label ID:
d9bf2076-4d3f-4118-ab38-54ab61631716
FDA Application Number: [6]
part341
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date: [9]
02-13-2013
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
RED (C48326 - DARK RED)
ORANGE (C48331 - LIGHT)
Flavor(s):
CHERRY (C73375)
CITRUS (C73378 - BLEND)

Product Packages

NDC Code 41250-031-02

Package Description: 1 KIT in 1 KIT * 355 mL in 1 BOTTLE (41250-668-40) * 355 mL in 1 BOTTLE (41250-473-40)

Product Details

What is NDC 41250-031?

The NDC code 41250-031 is assigned by the FDA to the product Nitetime Cough Daytime Cough which is a human over the counter drug product labeled by Meijer Distribution Inc. The generic name of Nitetime Cough Daytime Cough is dextromethorphan hydrobromide, doxylamine succinate. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 41250-031-02 1 kit in 1 kit * 355 ml in 1 bottle (41250-668-40) * 355 ml in 1 bottle (41250-473-40). 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 Nitetime Cough Daytime Cough?

•take only as directed•use dose cup•do not exceed 4 doses per 24 hoursadults and children 12 years and over30 mL (2 TBSP) every 6 hrschildren 4 to under 12 yearsask a doctorchildren under 4 yearsdo not use•when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Which are Nitetime Cough Daytime Cough UNII Codes?

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

Which are Nitetime Cough Daytime Cough 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 Nitetime Cough Daytime Cough?

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: 1090946 - dextromethorphan HBr 15 MG in 15 mL Oral Solution
  • RxCUI: 1090946 - dextromethorphan hydrobromide 1 MG/ML Oral Solution
  • RxCUI: 1090946 - dextromethorphan HBr 20 MG in 20 mL Oral Solution
  • RxCUI: 1090946 - dextromethorphan hydrobromide 5 MG per 5 ML Oral Solution
  • RxCUI: 1234386 - dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution

* Please review the disclaimer below.

Patient Education

Dextromethorphan


Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
[Learn More]


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]


* 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.

[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".