85110-301 NDC - PAINGEL (MENTHOL, METHYL SALICYLATE)

Drug Information

Product NDC: 85110-301
Proprietary Name: PAINGEL
Non Proprietary Name: MENTHOL, METHYL SALICYLATE
Active Ingredient(s): 10 g/100mL MENTHOL; 28.5 g/100mL METHYL SALICYLATE
Administration Route(s): TOPICAL
Dosage Form(s): SPRAY

Labeler Information

Field Name	Field Value
Labeler Name:	NACOR BUSINESS GROUP LLC
Product Type:	HUMAN OTC DRUG
FDA Application Number:	M017
Marketing Category:	OTC MONOGRAPH DRUG
Start Marketing Date:	11/28/2025

Package Information

No.	Package Code	Package Description	Billing Unit
1	85110-301-04	118 mL in 1 BOTTLE, SPRAY (85110-301-04)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	85110-301	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	PAINGEL	This is the date that the labeler indicates was the start of its marketing of the drug product.
NON PROPRIETARY NAME	MENTHOL, METHYL SALICYLATE	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
DOSAGE FORM NAME	SPRAY	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.
ROUTE NAME	TOPICAL	This 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.
START MARKETING DATE	11/28/2025	Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAME	OTC MONOGRAPH DRUG	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.
APPLICATION NUMBER	M017	This 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 NAME	NACOR BUSINESS GROUP LLC	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	MENTHOL; METHYL SALICYLATE	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	10; 28.5
ACTIVE INGRED UNIT	g/100mL; g/100mL

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This page was last updated on: 12/19/2025

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