Nighttime Severe Cold And Cough Liquid
NDC Package 49580-0502-8

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

Package Information

Nighttime Severe Cold And Cough (acetaminophen, diphenhydramine hcl, phenylephrine hcl) liquids is do not take more than directed (see overdose warning)do not take more than 6 doses (180 mL) in any 24-hour periodmeasure only with dosing cup provided. This formulation utilizes a liquid delivery system. Marketed by P & L Development, Llc, this product is identified by NDC 49580-0502 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
49580-0502-8
Package Description
245 mL in 1 BOTTLE, PLASTIC
Product Code
49580-0502
11-Digit Billing Format
49580050208
RxNorm Crosswalk
  • RxCUI: 1298348 - acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution
  • RxCUI: 1298348 - acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution
  • RxCUI: 1298348 - acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution
  • RxCUI: 1298348 - acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution
  • RxCUI: 1298348 - APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Nighttime Severe Cold And Cough
Non-Proprietary Name
Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
Substance Name
Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride
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 6 doses (180 mL) 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 and over 30 mL every 4 hourschildren under 12 years of age; do not use 

Regulatory & Marketing

Labeler Name
P & L Development, Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-30-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49580-0502-8 identifies a specific commercial package of 245 ml in 1 bottle, plastic of Nighttime Severe Cold And Cough, a human over the counter drug labeled by P & L Development, Llc. This liquid is formulated for oral use and contains acetaminophen; diphenhydramine hydrochloride; phenylephrine hydrochloride 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 P & L Development, Llc on April 30, 2021. The current certification is valid through December 31, 2026.

How is this P & L Development, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49580050208. 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 (5-4-1)
49580-0502-8
11-Digit CMS (5-4-2)
49580-0502-08

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