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NDC 82673-901 Daytime Cough Congestion Nighttime Cold Cough

Dextromethorphan Hbr,Guaifenesin,Diphenhydramine Hcl Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 82673-901?
  5. Daytime Cough Congestion Nighttime Cold Cough Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
82673-901
Proprietary Name:
Daytime Cough Congestion Nighttime Cold Cough
Non-Proprietary Name: [1]
Dextromethorphan Hbr, Guaifenesin, Diphenhydramine 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]
Kinderfarms, Llc
Labeler Code:
82673
Product Label ID:
f2113abf-c1a3-42a6-a25e-e30a31fcad95
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
05-30-2024
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Flavor(s):
BERRY (C73365)
CHERRY (C73375)

Code Structure Chart

Product Details

What is NDC 82673-901?

The NDC code 82673-901 is assigned by the FDA to the product Daytime Cough Congestion Nighttime Cold Cough which is a human over the counter drug product labeled by Kinderfarms, Llc. The generic name of Daytime Cough Congestion Nighttime Cold Cough is dextromethorphan hbr, guaifenesin, diphenhydramine hcl. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 82673-901-08 1 kit in 1 kit * 1 bottle, plastic in 1 box (82673-102-04) / 118 ml in 1 bottle, plastic * 1 bottle, plastic in 1 box (82673-191-04) / 118 ml in 1 bottle, plastic. 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 Cough Congestion Nighttime Cold Cough?

Daytimedo not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device.keep dosing cup with productmL = milliliter shake well before usingagedose children 6 to under 12 years 5-10 mL every 4 hours children 4 to under 6 years2.5-5 mL every 4 hours children under 4 yearsdo not use Nighttimeadults and children 6 years and over: do not exceed more than 6 doses in 24 hour unless directed by a doctormeasure only with dosing cup provided. Do not use any other dosing devicekeep dosing cup with productshake well before usingmL = milliliterAge Dose adults and children 12 years of age and over 10 mL every 4 hours  children 6 to under 12 years of age 5 mL every 4 hourschildren 4 to under 6 years of age do not use unless directed by a doctor  children under 4 years of age do not use

Which are Daytime Cough Congestion Nighttime Cold Cough UNII Codes?

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

Which are Daytime Cough Congestion Nighttime Cold 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 Daytime Cough Congestion Nighttime Cold 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: 1020138 - dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution
  • RxCUI: 1020138 - dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution
  • RxCUI: 1020138 - dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution
  • RxCUI: 1020138 - dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution
  • RxCUI: 1049906 - diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution

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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".