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NDC 55319-813 Daytime Nighttime Severe Cold And Flu

Acetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl Doxylaminesucinate Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 55319-813?
  5. Daytime Nighttime Severe Cold And Flu Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
55319-813
Proprietary Name:
Daytime Nighttime Severe Cold And Flu
Non-Proprietary Name: [1]
Acetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl Doxylaminesucinate
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]
Family Dollar (family Wellness)
Labeler Code:
55319
Product Label ID:
f80b321f-fcef-4a07-a82c-28c0f99d13f8
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]
07-31-2019
End Marketing Date: [10]
07-31-2025
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Flavor(s):
BERRY (C73365)

Product Packages

NDC Code 55319-813-16

Package Description: 1 KIT in 1 KIT * 237 mL in 1 BOTTLE * 237 mL in 1 BOTTLE

Product Details

What is NDC 55319-813?

The NDC code 55319-813 is assigned by the FDA to the product Daytime Nighttime Severe Cold And Flu which is a human over the counter drug product labeled by Family Dollar (family Wellness). The generic name of Daytime Nighttime Severe Cold And Flu is acetaminophen dextromethorphan hbr guaifenesin phenylephrine hcl doxylaminesucinate. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 55319-813-16 1 kit in 1 kit * 237 ml in 1 bottle * 237 ml in 1 bottle. 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 Daytime Nighttime Severe Cold And Flu?

DAYTIMEdo not take more than directed (see Overdose warning)do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL= milliliter adults and children 12 years and over30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 yearsask a doctor children under 4 years do not use NIGHTTIMEtake only as directed (see Overdose warning)Do not exceed 4 doses per 24 hoursmeasure only with dosing cup provided. Do not use any other dosing device.   mL= milliliterkeep dosing cup with productadults and children 12 years and over: 30 mL every 4 hourschildren under 12 years of age: do not usewhen using other Daytime or Nighttime products, carefully read each label or ensure correct dosing

Which are Daytime Nighttime Severe Cold And Flu UNII Codes?

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

Which are Daytime Nighttime Severe Cold And Flu 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 Daytime Nighttime Severe Cold And Flu?

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: 1369842 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution
  • RxCUI: 1369842 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution
  • RxCUI: 1369842 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution
  • RxCUI: 1369842 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution
  • RxCUI: 1369842 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution

* 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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".