80441-002 NDC - SIRENOL ANTISEPTIC TOPICAL ()

Drug Information

  • Product NDC: 80441-002
  • Proprietary Name: Sirenol Antiseptic Topical
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: BM GLOBAL ELEKTRONIK GIDA SANAYI VE DIS TICARET LIMITED SIRKETI
Product Type:
FDA Application Number: part333A
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:9/2/2020

Package Information

No. Package Code Package Description Billing Unit
180441-002-0125 mL in 1 BOTTLE (80441-002-01)
280441-002-0250 mL in 1 BOTTLE (80441-002-02)
380441-002-03100 mL in 1 BOTTLE (80441-002-03)
480441-002-04150 mL in 1 BOTTLE (80441-002-04)
580441-002-05200 mL in 1 BOTTLE (80441-002-05)
680441-002-06250 mL in 1 BOTTLE (80441-002-06)
780441-002-07500 mL in 1 BOTTLE (80441-002-07)
880441-002-081000 mL in 1 BOTTLE (80441-002-08)
980441-002-093785 mL in 1 BOTTLE (80441-002-09)
1080441-002-105000 mL in 1 BOTTLE (80441-002-10)
1180441-002-1110000 mL in 1 BOTTLE (80441-002-11)
1280441-002-126 NOT APPLICABLE in 1 PACKAGE (80441-002-12) / 5 mL in 1 NOT APPLICABLE
1380441-002-1310 NOT APPLICABLE in 1 PACKAGE (80441-002-13) / 5 mL in 1 NOT APPLICABLE
1480441-002-1420 NOT APPLICABLE in 1 PACKAGE (80441-002-14) / 5 mL in 1 NOT APPLICABLE
1580441-002-15100 NOT APPLICABLE in 1 PACKAGE (80441-002-15) / 5 mL in 1 NOT APPLICABLE
1680441-002-161000 NOT APPLICABLE in 1 PACKAGE (80441-002-16) / 5 mL in 1 NOT APPLICABLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC80441-002The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMESirenol Antiseptic TopicalThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE9/2/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERpart333AThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEBM GLOBAL ELEKTRONIK GIDA SANAYI VE DIS TICARET LIMITED SIRKETIName of Company corresponding to the labeler code segment of the Product NDC.

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

This page was last updated on: 12/6/2025

Previous Code
Next Code