Childrens Triacting Nighttime Liquid
NDC Package 49580-0379-4

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

Package Information

Childrens Triacting Nighttime (diphenhydramine hcl, phenylephrine hcl) liquids is do not give more than 6 doses in 24 hours unless directed by a doctor. This formulation utilizes a liquid delivery system. Marketed by P & L Development, Llc, this product is identified by NDC 49580-0379 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
49580-0379-4
Package Description
1 BOTTLE, PLASTIC in 1 BOX / 118 mL in 1 BOTTLE, PLASTIC
Product Code
49580-0379
11-Digit Billing Format
49580037904
RxNorm Crosswalk
  • RxCUI: 1236048 - diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1236048 - diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1236048 - diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution
  • RxCUI: 1236048 - diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Childrens Triacting Nighttime Cold And Cough Readyincase
Non-Proprietary Name
Diphenhydramine Hcl, Phenylephrine Hcl
Substance Name
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 give more than 6 doses in 24 hours unless directed by a doctor. measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = millilitershake well before using age dose children 6 to under 12 years10 mL every 4 hours children 4 to under 6 yearsdo not use unless directed by a doctor children under 4 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
11-30-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49580-0379-4 identifies a specific commercial package of 1 bottle, plastic in 1 box / 118 ml in 1 bottle, plastic of Childrens Triacting Nighttime Cold And Cough Readyincase, a human over the counter drug labeled by P & L Development, Llc. This liquid is formulated for oral use and contains 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 November 30, 2014. 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: 49580037904. 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)
49580-0379-4
11-Digit CMS (5-4-2)
49580-0379-04

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