jelcaine sterile

Generic: lidocaine hcl jelly usp, 2%

Labeler: brookfield pharmaceuticals, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name jelcaine sterile
Generic Name lidocaine hcl jelly usp, 2%
Labeler brookfield pharmaceuticals, llc
Dosage Form JELLY
Routes
TOPICAL
Active Ingredients

lidocaine hydrochloride 20 mg/mL

Manufacturer
Brookfield Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 71351-025
Product ID 71351-025_433faabc-d940-29cd-e063-6294a90a4787
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2024-09-10

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 71351025
Hyphenated Format 71351-025

Supplemental Identifiers

RxCUI
1011852
UPC
0371351025302
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 jelcaine sterile (source: ndc)
Generic Name lidocaine hcl jelly usp, 2% (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 30 mL in 1 TUBE (71351-025-30)
source: ndc

Packages (1)

71351-025-30 30 mL in 1 TUBE (71351-025-30)

Ingredients (1)

lidocaine hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Jelcaine Sterile ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "433faabc-d940-29cd-e063-6294a90a4787", "openfda": {"upc": ["0371351025302"], "unii": ["V13007Z41A"], "rxcui": ["1011852"], "spl_set_id": ["1a39d1de-7aa2-3068-e063-6394a90aed85"], "manufacturer_name": ["Brookfield Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 TUBE (71351-025-30)", "package_ndc": "71351-025-30", "marketing_start_date": "20240910"}], "brand_name": "Jelcaine Sterile", "product_id": "71351-025_433faabc-d940-29cd-e063-6294a90a4787", "dosage_form": "JELLY", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "71351-025", "generic_name": "Lidocaine HCl Jelly USP, 2%", "labeler_name": "Brookfield Pharmaceuticals, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Jelcaine Sterile", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240910", "listing_expiration_date": "20261231"}