87916-002 NDC - HEMPE HOT MUSCLE AND JOINT GEL (HEMPE)

Drug Information

Product NDC: 87916-002
Proprietary Name: Hempe HOT Muscle and Joint Gel
Non Proprietary Name: Hempe
Active Ingredient(s): 2.5 mg/100mL MENTHOL, UNSPECIFIED FORM
Administration Route(s): TOPICAL
Dosage Form(s): GEL

Labeler Information

Field Name	Field Value
Labeler Name:	Healthcare International Research Limited
Product Type:	HUMAN OTC DRUG
FDA Application Number:	M017
Marketing Category:	OTC MONOGRAPH DRUG
Start Marketing Date:	8/1/2026

Package Information

No.	Package Code	Package Description	Billing Unit
1	87916-002-15	150 mL in 1 BOTTLE, DISPENSING (87916-002-15)
2	87916-002-50	50 mL in 1 BOTTLE, DISPENSING (87916-002-50)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	87916-002
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	Hempe HOT Muscle and Joint Gel	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.
NON PROPRIETARY NAME	Hempe	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	GEL	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
ROUTE NAME	TOPICAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	8/1/2026	The translation of the route code submitted by the firm, indicating route of administration.
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	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	Healthcare International Research Limited	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	MENTHOL, UNSPECIFIED FORM	Name of Company corresponding to the labeler code segment of the Product NDC.
ACTIVE NUMERATOR STRENGTH	2.5
ACTIVE INGRED UNIT	mg/100mL

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This page was last updated on: 9/11/2026

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