Night Time Cold And Flu Relief Capsule, Liquid Filled
NDC Package 81522-899-16

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

Package Information

Night Time Cold And Flu Relief (acetaminophen, dextromethorphan hbr, doxylamine succinate) capsules is do not take more than directed (see Overdose warning)do not take more than 4 doses in 24 hours adults and children 12 years and over: take 2 softgels with water every 6 hours swallow whole; do not crush, chew, or dissolve children under 12 years: do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Fsa Store Inc. (caring Mills), this product is identified by NDC 81522-899 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
81522-899-16
Package Description
16 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
81522-899
11-Digit Billing Format
81522089916
RxNorm Crosswalk
  • RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule
  • RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule
  • RxCUI: 1094549 - APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule

Clinical Specifications

Proprietary Name
Night Time Cold And Flu Relief
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
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 24 hours adults and children 12 years and over: take 2 softgels with water every 6 hours swallow whole; do not crush, chew, or dissolve children under 12 years: do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Regulatory & Marketing

Labeler Name
Fsa Store Inc. (caring Mills)
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-25-2022
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 81522-899-16 identifies a specific commercial package of 16 blister pack in 1 carton / 1 capsule, liquid filled in 1 blister pack of Night Time Cold And Flu Relief, a human over the counter drug labeled by Fsa Store Inc. (caring Mills). This capsule, liquid filled 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 Fsa Store Inc. (caring Mills) on November 25, 2022. The current certification is valid through December 31, 2027.

How is this Fsa Store Inc. (caring Mills) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81522089916. 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)
81522-899-16
11-Digit CMS (5-4-2)
81522-0899-16

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