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  5. NDC Package Code: 0067-0105-08 Theraflu Severe Cold Relief Nighttime

NDC Package 0067-0105-08 Theraflu Severe Cold Relief Nighttime

Acetaminophen,Diphenhydramine Hcl Syrup Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0067-0105-08
Package Description:
245.5 mL in 1 BOTTLE
Product Code:
0067-0105
Proprietary Name:
Theraflu Severe Cold Relief Nighttime
Non-Proprietary Name:
Acetaminophen, Diphenhydramine Hcl
Substance Name:
Acetaminophen; Diphenhydramine Hydrochloride
Usage Information:
•do not use more than directed•measure the dose correctly using the enclosed dosing cup•take every 4 hours in dosing cup provided, while symptoms persist•do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctorAgeDoseAdults and children 12 years of age and over30 mLChildren under 12 years of agedo not use
11-Digit NDC Billing Format:
00067010508
NDC to RxNorm Crosswalk:
  • RxCUI: 1294607 - acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 30 mL Oral Solution
  • RxCUI: 1294607 - acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML Oral Solution
  • RxCUI: 1294607 - APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML Oral Solution
  • RxCUI: 1294607 - APAP 325 MG / diphenhydramine hydrochloride 12.5 MG per 15 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Haleon Us Holdings Llc
    Dosage Form:
    Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 650 mg/30mL
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/30mL
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    12-01-2023
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0067-0105-08?

    The NDC Packaged Code 0067-0105-08 is assigned to a package of 245.5 ml in 1 bottle of Theraflu Severe Cold Relief Nighttime, a human over the counter drug labeled by Haleon Us Holdings Llc. The product's dosage form is syrup and is administered via oral form.

    Is NDC 0067-0105 included in the NDC Directory?

    Yes, Theraflu Severe Cold Relief Nighttime with product code 0067-0105 is active and included in the NDC Directory. The product was first marketed by Haleon Us Holdings Llc on December 01, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0067-0105-08?

    The 11-digit format is 00067010508. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20067-0105-085-4-200067-0105-08