Nighttime Cold And Flu Relief Liquid
NDC Package 21130-044-08

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Nighttime Cold And Flu Relief (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate) liquids is do not take more than directed (see Overdose warning)do not take more than 4 doses in any 24-hour periodmeasure only with dosing cup provided. This formulation utilizes a liquid delivery system. Marketed by Safeway, Inc., this product is identified by NDC 21130-044 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
21130-044-08
Package Description
237 mL in 1 BOTTLE, PLASTIC
Product Code
21130-044
11-Digit Billing Format
21130004408
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Nighttime Cold And Flu Relief
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not take more than directed (see Overdose warning)do not take more than 4 doses in any 24-hour periodmeasure only with dosing cup provided. Do not use any other dosing devicemL = milliliterkeep dosing cup with productadults and children 12 years of age: 30 mL every 6 hourschildren under 12 years of age: do not useWhen using other Day Time or Night Time products, carefully read each label to ensure correct dosing

Regulatory & Marketing

Labeler Name
Safeway, Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-30-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (21130-044). Click a package code to view its specific billing and regulatory data.

21130-044-12
355 mL in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 21130-044-08 identifies a specific commercial package of 237 ml in 1 bottle, plastic of Nighttime Cold And Flu Relief, a human over the counter drug labeled by Safeway, Inc.. This liquid is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; doxylamine succinate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Safeway, Inc. on June 30, 2014. The current certification is valid through December 31, 2026.

How is this Safeway, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21130004408. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
21130-044-08
11-Digit CMS (5-4-2)
21130-0044-08

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.