lidocaine hydrochloride

Generic: lidocaine hydrochloride

Labeler: safetec of america, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine hydrochloride
Generic Name lidocaine hydrochloride
Labeler safetec of america, inc.
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

lidocaine hydrochloride 20 mg/mL

Manufacturer
Safetec of America, Inc.

Identifiers & Regulatory

Product NDC 61010-5100
Product ID 61010-5100_114b1a82-0728-fe2e-e063-6394a90a309e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2011-08-02

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] antiarrhythmic [epc] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 610105100
Hyphenated Format 61010-5100

Supplemental Identifiers

RxCUI
1010769
UNII
V13007Z41A

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lidocaine hydrochloride (source: ndc)
Generic Name lidocaine hydrochloride (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 59.1 mL in 1 BOTTLE, SPRAY (61010-5100-4)
  • 118 mL in 1 BOTTLE, SPRAY (61010-5100-5)
source: ndc

Packages (2)

61010-5100-4 59.1 mL in 1 BOTTLE, SPRAY (61010-5100-4) 61010-5100-5 118 mL in 1 BOTTLE, SPRAY (61010-5100-5)

Ingredients (1)

lidocaine hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Lidocaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "114b1a82-0728-fe2e-e063-6394a90a309e", "openfda": {"unii": ["V13007Z41A"], "rxcui": ["1010769"], "spl_set_id": ["8eb3e7e2-26e5-430e-89aa-40a0367c637e"], "manufacturer_name": ["Safetec of America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "59.1 mL in 1 BOTTLE, SPRAY (61010-5100-4)", "package_ndc": "61010-5100-4", "marketing_start_date": "20110802"}, {"sample": false, "description": "118 mL in 1 BOTTLE, SPRAY (61010-5100-5)", "package_ndc": "61010-5100-5", "marketing_start_date": "20110802"}], "brand_name": "Lidocaine Hydrochloride", "product_id": "61010-5100_114b1a82-0728-fe2e-e063-6394a90a309e", "dosage_form": "LIQUID", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "61010-5100", "generic_name": "Lidocaine Hydrochloride", "labeler_name": "Safetec of America, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Lidocaine Hydrochloride", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20110802", "listing_expiration_date": "20261231"}