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  4. NDC Product Code: 68210-0101 Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

NDC 68210-0101 Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 68210-0101?
  5. Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 68210-0101 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
68210-0101
Proprietary Name:
Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Spirit Pharmaceuticals, Llc
Labeler Code:
68210
Product Label ID:
17aebf77-55d8-4a02-8391-28bbd9c3b373
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]
10-15-2009
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331)
Shape:
OVAL (C48345)
Size(s):
20 MM
Score:
1

Code Structure Chart

Product Details

What is NDC 68210-0101?

The NDC code 68210-0101 is assigned by the FDA to the product Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride which is product labeled by Spirit Pharmaceuticals, Llc. The product's dosage form is . The product is distributed in 6 packages with assigned NDC codes 68210-0101-1 4 capsule, liquid filled in 1 box , 68210-0101-2 100 capsule, liquid filled in 1 box , 68210-0101-3 1000 capsule, liquid filled in 1 box , 68210-0101-4 5000 capsule, liquid filled in 1 box , 68210-0101-5 10000 capsule, liquid filled in 1 box , 68210-0101-6 2500 capsule, liquid filled in 1 box . 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 Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride?

Take only as recommended - see Overdose warningdo not exceed 6 doses per 24 hoursadults and children 12 years and over2 LiquiCaps with water every 4 hourschildren under 12 yearsask a doctorwhen using other DayQuil or NyQuil products, carefully read each label to insure correct dosing

Which are Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride UNII Codes?

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

Which are Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride 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 Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride?

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: 1086997 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1086997 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

* Please review the disclaimer below.

Product Footnotes

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".