topicaine

Generic: lidocaine 4%

Labeler: esba laboratories inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topicaine
Generic Name lidocaine 4%
Labeler esba laboratories inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

lidocaine 4 g/100g

Manufacturer
ESBA LABORATORIES INC.

Identifiers & Regulatory

Product NDC 63135-312
Product ID 63135-312_47e8cec4-fde0-1956-e063-6394a90a1bdc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2027-12-31
Marketing Start 2003-04-20

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 63135312
Hyphenated Format 63135-312

Supplemental Identifiers

RxCUI
1291672 1651001
UPC
0363135312135
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 topicaine (source: ndc)
Generic Name lidocaine 4% (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 4 g/100g
source: ndc
Packaging
  • 113 g in 1 TUBE (63135-312-04)
  • 1 TUBE in 1 BOX (63135-312-13) / 10 g in 1 TUBE
  • 1 TUBE in 1 BOX (63135-312-30) / 30 g in 1 TUBE
source: ndc

Packages (3)

63135-312-04 113 g in 1 TUBE (63135-312-04) 63135-312-13 1 TUBE in 1 BOX (63135-312-13) / 10 g in 1 TUBE 63135-312-30 1 TUBE in 1 BOX (63135-312-30) / 30 g in 1 TUBE

Ingredients (1)

lidocaine (4 g/100g)

Linked Drug Pages (1)

TOPICAINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "47e8cec4-fde0-1956-e063-6394a90a1bdc", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "upc": ["0363135312135"], "unii": ["98PI200987"], "rxcui": ["1291672", "1651001"], "spl_set_id": ["7f96e980-891e-743d-e053-2a91aa0aea5f"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["ESBA LABORATORIES INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "113 g in 1 TUBE (63135-312-04)", "package_ndc": "63135-312-04", "marketing_start_date": "20030420"}, {"sample": false, "description": "1 TUBE in 1 BOX (63135-312-13)  / 10 g in 1 TUBE", "package_ndc": "63135-312-13", "marketing_start_date": "20030420"}, {"sample": false, "description": "1 TUBE in 1 BOX (63135-312-30)  / 30 g in 1 TUBE", "package_ndc": "63135-312-30", "marketing_start_date": "20030420"}], "brand_name": "TOPICAINE", "product_id": "63135-312_47e8cec4-fde0-1956-e063-6394a90a1bdc", "dosage_form": "GEL", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "63135-312", "generic_name": "LIDOCAINE 4%", "labeler_name": "ESBA LABORATORIES INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TOPICAINE", "active_ingredients": [{"name": "LIDOCAINE", "strength": "4 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20030420", "listing_expiration_date": "20271231"}