Drug Information

Product NDC: 69510-355

Proprietary Name: Ipana 20% Benzocaine Topical

Non Proprietary Name: Benzocaine

Active Ingredient(s):
  • 200 mg/g BENZOCAINE

Administration Route(s): DENTAL

Dosage Form(s): GEL

Labeler Information

Labeler Name: Maxill Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number: part356
Start Marketing Date:8/1/2016

Package Information

No. Package Code Package Description Billing Unit
169510-355-3028 g in 1 JAR (69510-355-30)

NDC Record

Field Name Field Value Definition
PRODUCT NDC69510-355The 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 NAMEHUMAN OTC DRUGIndicates 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 NAMEIpana 20% Benzocaine TopicalThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBenzocaineThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEGELThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEDENTALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/1/2016This 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 NUMBERpart356This 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 NAMEMaxill Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBENZOCAINEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

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This page was last updated on: 7/3/2020