Topcare Daytime Nitetime Cold And Flu Relief Kit
NDC 76162-903

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 76162-903?
  4. Topcare Daytime Nitetime Cold And Flu Relief Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

Topcare Daytime Nitetime Cold And Flu Relief (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate) is a OTC MONOGRAPH DRUG-approved product labeled by Topco Associates Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit. This product entry covers the primary NDC 76162-903 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
76162-903
Proprietary Name:
Topcare Daytime Nitetime Cold And Flu Relief
Non-Proprietary Name: [1]
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Topco Associates Llc
Labeler Code:
76162
Product Label ID:
560fb22b-391f-4d7b-a6fd-38d577d404b0
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
08-27-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 76162-903?

The NDC code 76162-903 is assigned by the FDA to the product Topcare Daytime Nitetime Cold And Flu Relief. It is commonly known by its generic name, acetaminophen, dextromethorphan hydrobromide, doxylamine succinate. This pharmaceutical product is labeled by Topco Associates Llc and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 76162-903-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

•take only as directed – see Overdose warning•only use the dose cup provided•do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 4 hrschildren 6 to under 12 yrs15 mL every 4 hrschildren 4 to under 6 yrsask a doctorchildren under 4 yrsdo not use •take only as directed – see Overdose warning•only use the dose cup provided•do not exceed 4 doses per 24 hrs adults & children 12 yrs & over30 mL every 4 hrschildren 6 to under 12 yrs15 mL every 4 hrschildren 4 to under 6 yrsask a doctorchildren under 4 yrsdo not use

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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: 1042675 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution
  • RxCUI: 1042675 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
  • RxCUI: 1042675 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
  • RxCUI: 1042675 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
  • RxCUI: 1042675 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution

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Product & Regulatory Definitions
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.
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.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".