puregen labs maximum strength lidocaine

Generic: lidocaine

Labeler: advanced rx llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name puregen labs maximum strength lidocaine
Generic Name lidocaine
Labeler advanced rx llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

lidocaine 50 mg/g

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-813
Product ID 80513-813_15cfdc73-c2f3-528e-e063-6394a90a07ae
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2024-04-22

Pharmacologic Class

Established (EPC)
amide local anesthetic [epc] antiarrhythmic [epc]
Chemical Structure
amides [cs]
Physiologic Effect
local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80513813
Hyphenated Format 80513-813

Supplemental Identifiers

RxCUI
1366789
UPC
0380513001054
UNII
98PI200987
NUI
N0000175682 M0000897 N0000175426 N0000175976

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 puregen labs maximum strength lidocaine (source: ndc)
Generic Name lidocaine (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 170 g in 1 TUBE (80513-813-06)
source: ndc

Packages (1)

80513-813-06 170 g in 1 TUBE (80513-813-06)

Ingredients (1)

lidocaine (50 mg/g)

Linked Drug Pages (1)

PUREGEN LABS Maximum Strength Lidocaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "15cfdc73-c2f3-528e-e063-6394a90a07ae", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "upc": ["0380513001054"], "unii": ["98PI200987"], "rxcui": ["1366789"], "spl_set_id": ["f4f89582-49e6-424a-bea7-0694484a7c99"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "170 g in 1 TUBE (80513-813-06)", "package_ndc": "80513-813-06", "marketing_start_date": "20240422"}], "brand_name": "PUREGEN LABS Maximum Strength Lidocaine", "product_id": "80513-813_15cfdc73-c2f3-528e-e063-6394a90a07ae", "dosage_form": "CREAM", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "80513-813", "generic_name": "LIDOCAINE", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PUREGEN LABS Maximum Strength Lidocaine", "active_ingredients": [{"name": "LIDOCAINE", "strength": "50 mg/g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240422", "listing_expiration_date": "20261231"}