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  4. NDC Product Code: 51316-123 Cold And Flu Daytime Nighttime

NDC 51316-123 Cold And Flu Daytime Nighttime

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 51316-123?
  5. Cold And Flu Daytime Nighttime Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
51316-123
Proprietary Name:
Cold And Flu Daytime Nighttime
Non-Proprietary Name: [1]
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
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]
Cvs Woonsocket Prescription Center, Incorporated
Labeler Code:
51316
Product Label ID:
dcb33d5f-87fa-4043-9b6d-36adec96796c
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
07-28-2023
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331)
RED (C48326 - MAROON)
Flavor(s):
MENTHOL (C73403)
CHERRY (C73375)

Code Structure Chart

Product Details

What is NDC 51316-123?

The NDC code 51316-123 is assigned by the FDA to the product Cold And Flu Daytime Nighttime which is a human over the counter drug product labeled by Cvs Woonsocket Prescription Center, Incorporated. The generic name of Cold And Flu Daytime Nighttime is acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 51316-123-02 1 kit in 1 package * 355 ml in 1 bottle, plastic (51316-120-02) * 355 ml in 1 bottle, plastic (51316-130-02). 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 Cold And Flu Daytime Nighttime?

Do not take more than directeddo not exceed 4 doses per 24 hoursmL = milliliteronly use the dose cup providedadults and children 12 years and over30 mL every 4 hourschildren 6 to under 12 years15 mL every 4 hourschildren under 6 yearsdo not use do not take more than directeddo not exceed 4 doses per 24 hoursmL = milliliteronly use the dose cup providedadults and children 12 years and over: 30 mL every 6 hourschildren under 12 years: do not use

Which are Cold And Flu Daytime Nighttime UNII Codes?

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

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

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: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
  • RxCUI: 1043400 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
  • RxCUI: 1043400 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
  • RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
  • RxCUI: 1043400 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 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.

[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".