41167-1710 NDC - ICY HOT WITH LIDOCAINE (LIDOCAINE HCL AND MENTHOL)

Drug Information

  • Product NDC: 41167-1710
  • Proprietary Name: Icy Hot with Lidocaine
  • Non Proprietary Name: Lidocaine HCl and Menthol
  • Active Ingredient(s): .4 g/g LIDOCAINE; .1 g/g MENTHOL
  • Administration Route(s): TOPICAL
  • Dosage Form(s): CREAM
  • Pharmacy Class(es): Amide Local Anesthetic [EPC]; Amides [CS]; Antiarrhythmic [EPC]; Local Anesthesia [PE]

Labeler Information

Field Name Field Value
Labeler Name: Chattem, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number: M017
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:3/1/2016

Package Information

No. Package Code Package Description Billing Unit
141167-1710-01 TUBE in 1 CARTON (41167-1710-0) / 76.5 g in 1 TUBE
241167-1710-21 TUBE in 1 CARTON (41167-1710-2) / 49.6 g in 1 TUBEGM

NDC Record

Field Name Field Value Definition
PRODUCT NDC41167-1710The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PRODUCT TYPE NAMEHUMAN OTC DRUGThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
PROPRIETARY NAMEIcy Hot with LidocaineThe translation of the dosage form Code submitted by the firm.
PROPRIETARY NAME SUFFIXPain RelievingThe translation of the route code submitted by the firm, indicating route of administration.
NON PROPRIETARY NAMELidocaine HCl and MentholThis is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAMECREAMProduct 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 NAMETOPICALThis 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 DATE3/1/2016Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGAn 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.
APPLICATION NUMBERM017 
LABELER NAMEChattem, Inc. 
SUBSTANCE NAMELIDOCAINE; MENTHOLAn 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.4; .1 
ACTIVE INGRED UNITg/g; g/g 
PHARM CLASSESAmide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] 

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This page was last updated on: 1/16/2026

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