Lidocaine Hcl 4%

Walgreens Co.
Human Otc Drug
NDC 0363-4510

Lidocaine Hcl 4% is a human otc drug labeled by 'Walgreens Co.'. National Drug Code (NDC) number for Lidocaine Hcl 4% is 0363-4510. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Lidocaine Hcl 4% drug includes Lidocaine Hydrochloride - 4 g/100g . The currest status of Lidocaine Hcl 4% drug is Active.

Drug Information:

Drug NDC:	0363-4510
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.
Proprietary Name:	Lidocaine Hcl 4%
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Lidocaine Hcl 4%
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Walgreens Co.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Ointment
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	LIDOCAINE HYDROCHLORIDE - 4 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	04 Jan, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	15 Jan, 2025
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.
Application Number:	part348
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	WALGREENS CO.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0311917208367
UPC stands for Universal Product Code.
UNII:	V13007Z41A
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Amide Local Anesthetic [EPC] Amides [CS] Antiarrhythmic [EPC] Local Anesthesia [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0363-4510-47	133 g in 1 BOTTLE (0363-4510-47)	04 Jan, 2019	N/A	No
0363-4510-72	76.5 g in 1 BOTTLE (0363-4510-72)	04 Jan, 2019	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

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Lidocaine Hcl 4%

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Purpose:

Topical anesthetic

Product Elements:

Lidocaine hcl 4% lidocaine hcl 4% .alpha.-tocopherol acetate, dl- water polysorbate 80 lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous lecithin, soybean benzyl alcohol carbomer 940 propylene glycol trolamine

Indications and Usage:

Temporary relieves minor joint and muscle pain

Warnings:

For external use only do not use on large areas of the body or on cut, irritated or swollen skin, on puncture wounds, for more than one week without consulting a doctor. when using this product use only as directed. read and follow all directions and warnings on this carton, do not allow contact with the eyes, do not bandage or apply local heat (such as heating pads) to the area of use. stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days. if pregnant or breast-feeding , ask a health professional before use. keep out of reach of children and pets. if swallowed, get medical help or contact a poison control center right away.

Dosage and Administration:

Adults and children 12 years and older: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24-hour period. before and after applying, wash hands with soap and water. children under 12 years: ask a doctor

Package Label Principal Display Panel:

451-27 451-47

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.