lidocaine

Generic: lidocaine

Labeler: stratus pharmaceuticals inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine
Generic Name lidocaine
Labeler stratus pharmaceuticals inc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

lidocaine 50 mg/g

Manufacturer
STRATUS PHARMACEUTICALS INC

Identifiers & Regulatory

Product NDC 58980-823
Product ID 58980-823_4b196450-e9de-4c85-8652-42d926d951d5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2019-08-12

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 58980823
Hyphenated Format 58980-823

Supplemental Identifiers

RxCUI
1534792
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 lidocaine (source: ndc)
Generic Name lidocaine (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (58980-823-05) / 14.17 g in 1 TUBE
  • 1 TUBE in 1 BOX (58980-823-30) / 28.35 g in 1 TUBE
source: ndc

Packages (2)

58980-823-05 1 TUBE in 1 BOX (58980-823-05) / 14.17 g in 1 TUBE 58980-823-30 1 TUBE in 1 BOX (58980-823-30) / 28.35 g in 1 TUBE

Ingredients (1)

lidocaine (50 mg/g)

Linked Drug Pages (1)

LIDOCAINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4b196450-e9de-4c85-8652-42d926d951d5", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "unii": ["98PI200987"], "rxcui": ["1534792"], "spl_set_id": ["87a4f559-a4f6-4b9f-98de-b55b073a11c6"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["STRATUS PHARMACEUTICALS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (58980-823-05)  / 14.17 g in 1 TUBE", "package_ndc": "58980-823-05", "marketing_start_date": "20231218"}, {"sample": false, "description": "1 TUBE in 1 BOX (58980-823-30)  / 28.35 g in 1 TUBE", "package_ndc": "58980-823-30", "marketing_start_date": "20190812"}], "brand_name": "LIDOCAINE", "product_id": "58980-823_4b196450-e9de-4c85-8652-42d926d951d5", "dosage_form": "CREAM", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "58980-823", "generic_name": "LIDOCAINE", "labeler_name": "STRATUS PHARMACEUTICALS INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "LIDOCAINE", "active_ingredients": [{"name": "LIDOCAINE", "strength": "50 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190812", "listing_expiration_date": "20261231"}