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  5. NDC Package Code: 78691-031-00 Biopure Alcohol Cotton Swabs

NDC Package 78691-031-00 Biopure Alcohol Cotton Swabs

Isopropyl Alcohol,Cotton Swab Swab Topical - 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:
78691-031-00
Package Description:
15 APPLICATOR in 1 BOX / 1 mL in 1 APPLICATOR
Product Code:
78691-031
Proprietary Name:
Biopure Alcohol Cotton Swabs
Non-Proprietary Name:
Isopropyl Alcohol, Cotton Swab
Substance Name:
Isopropyl Alcohol
Usage Information:
For adults and children 2 years of age and older: Tear plastic wrapper before use. Clean the affected area. Hold swab vertically with the yellow tip facing upwards. Hold in the center of the tube with one hand and yellow tip with the other hand. Gently snap the yellow tip in either direction to break the seal. Allow the bottom tip to fill with alcohol until it becomes wet. Apply the swab to the affected area. Discard after use. For children under 2 years: Consult a doctor.
11-Digit NDC Billing Format:
78691003100
Product Type:
Human Otc Drug
Labeler Name:
Quest Usa Corp
Dosage Form:
Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.
Administration Route(s):
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s):
ISOPROPYL ALCOHOL .15 mL/mL
Sample Package:
No
FDA Application Number:
M003
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
08-15-2025
Listing Expiration Date:
12-31-2026
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 78691-031-00?

The NDC Packaged Code 78691-031-00 is assigned to a package of 15 applicator in 1 box / 1 ml in 1 applicator of Biopure Alcohol Cotton Swabs, a human over the counter drug labeled by Quest Usa Corp. The product's dosage form is swab and is administered via topical form.

Is NDC 78691-031 included in the NDC Directory?

Yes, Biopure Alcohol Cotton Swabs with product code 78691-031 is active and included in the NDC Directory. The product was first marketed by Quest Usa Corp on August 15, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 78691-031-00?

The 11-digit format is 78691003100. 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
5-3-278691-031-005-4-278691-0031-00