NDC Package 36800-307-62 Topcare Nite Time Cold And Flu

Acetaminophen,Dextromethorphan Hydrobromide,Doxylamine Succinate,Phenylephrine - View Billable Units, 11-Digit Format, RxNorm

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:
36800-307-62
Package Description:
12 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
Proprietary Name:
Topcare Nite Time Cold And Flu
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride
Usage Information:
•take only as directed – see overdose warning•do not exceed 8 caplets per 24 hrsadults & children 12 yrs & over2 caplets with water every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use
11-Digit NDC Billing Format:
36800030762
NDC to RxNorm Crosswalk:
  • RxCUI: 1546881 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1546881 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1546881 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Topco Associates Llc
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    09-10-2019
    Listing Expiration Date:
    12-31-2024
    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 36800-307-62?

    The NDC Packaged Code 36800-307-62 is assigned to a package of 12 blister pack in 1 carton / 2 tablet, film coated in 1 blister pack of Topcare Nite Time Cold And Flu, a human over the counter drug labeled by Topco Associates Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 36800-307 included in the NDC Directory?

    Yes, Topcare Nite Time Cold And Flu with product code 36800-307 is active and included in the NDC Directory. The product was first marketed by Topco Associates Llc on September 10, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 36800-307-62?

    The 11-digit format is 36800030762. 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 5-3-2 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
    5-3-236800-307-625-4-236800-0307-62