NDC 46122-614 Gnp Lidocaine Maximum Strength

Lidocaine Hcl

NDC Product Code 46122-614

NDC 46122-614-10

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 76.5 g in 1 BOTTLE, PLASTIC

NDC Product Information

Gnp Lidocaine Maximum Strength with NDC 46122-614 is a a human over the counter drug product labeled by Amerisource Bergen. The generic name of Gnp Lidocaine Maximum Strength is lidocaine hcl. The product's dosage form is cream and is administered via topical form.

Labeler Name: Amerisource Bergen

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
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.

Gnp Lidocaine Maximum Strength Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • STEARETH-21 (UNII: 53J3F32P58)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Amerisource Bergen
Labeler Code: 46122
FDA Application Number: part348 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
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.

Start Marketing Date: 02-24-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Gnp Lidocaine Maximum Strength Product Label Images

Gnp Lidocaine Maximum Strength Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Lidocaine HCl 4%


Topical analgesic


  • Temporarily relieves pain and itching due to:minor burnssunburnminor cutsscrapesinsect bitesminor skin irritations


For external use only

Otc - Do Not Use

Do not use in large quantities, particularly over raw surfaces or blistered areas

When Using This Product

When using this product do not get into eyes

Otc - Stop Use

  • Stop use and ask a doctor ifcondition gets worsesymptoms last for more than 7 dayssymptoms clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


  • Adults and children 2 years and over: apply to affected area not more than 3 to 4 times dailychildren under 2 years: ask a doctor

Other Information

Store between 20 °C and 25 °C (68 °F and 77 °F)

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,

C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21

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Good Neighbor PharmacyCompares to Asperceme active ingredientLidocaine Pain Relieving CrèmeLidocaine HCL 4% - Topical AnalgesicNet Wt 2.7 oz (76.5g)

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