73927-0008 NDC - NOBATON 1% ALPHA HYDROXY ACID AMPOULE (NOBATON 1% ALPHA HYDROXY ACID AMPOULE TOOTHPASTE)

Drug Information

Product NDC: 73927-0008
Proprietary Name: Nobaton 1% Alpha Hydroxy Acid Ampoule
Non Proprietary Name: Nobaton 1% Alpha Hydroxy Acid Ampoule Toothpaste
Active Ingredient(s): .0975 g/100g OLAFLUR; 1 g/100g SODIUM MONOFLUOROPHOSPHATE
Administration Route(s): DENTAL
Dosage Form(s): OINTMENT

Labeler Information

Field Name	Field Value
Labeler Name:	BD TECHNOLOGY CO.,LTD
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED DRUG OTHER
Start Marketing Date:	4/21/2025

Package Information

No.	Package Code	Package Description	Billing Unit
1	73927-0008-1	35 g in 1 TUBE (73927-0008-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	73927-0008	The 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.
PRODUCT TYPE NAME	HUMAN OTC DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	Nobaton 1% Alpha Hydroxy Acid Ampoule	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Nobaton 1% Alpha Hydroxy Acid Ampoule Toothpaste	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	OINTMENT	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	DENTAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	4/21/2025	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED DRUG OTHER	Product 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.
LABELER NAME	BD TECHNOLOGY CO.,LTD	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	OLAFLUR; SODIUM MONOFLUOROPHOSPHATE	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	.0975; 1
ACTIVE INGRED UNIT	g/100g; g/100g

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: 7/4/2025

Previous Code

Next Code