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  4. NDC Product Code: 50844-529 Cold Relief Multi-symptom

NDC 50844-529 Cold Relief Multi-symptom

Acetaminophen,Chlorpheniramine Maleate,Dextromethorphan Hbr,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 50844-529?
  5. Cold Relief Multi-symptom Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
50844-529
Proprietary Name:
Cold Relief Multi-symptom
Non-Proprietary Name: [1]
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr, 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]
L.n.k. International, Inc.
Labeler Code:
50844
Product Label ID:
2ed25f69-89ef-4c50-946a-7e7b9df1ca8a
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
07-21-2005
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
BLUE (C48333)
Shape:
OVAL (C48345)
Size(s):
17 MM
Imprint(s):
44;470
44;473
Score:
1
Flavor(s):
MENTHOL (C73403)

Code Structure Chart

Product Details

What is NDC 50844-529?

The NDC code 50844-529 is assigned by the FDA to the product Cold Relief Multi-symptom which is a human over the counter drug product labeled by L.n.k. International, Inc.. The generic name of Cold Relief Multi-symptom is acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 50844-529-09 1 kit in 1 carton * 12 tablet, film coated in 1 blister pack * 8 tablet, film coated 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 Cold Relief Multi-symptom?

Do not take more than directedadults and children 12 years and over take 2 caplets every 4 hoursswallow whole – do not crush, chew, or dissolvedo not take more than 10 caplets in 24 hourschildren under 12 years: ask a doctor

Which are Cold Relief Multi-symptom UNII Codes?

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

Which are Cold Relief 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 Cold Relief 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: 1086991 - acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1086991 - acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1086991 - APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1094538 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1094538 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet

* 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".