dibucaine

Generic: dibucaine 1%

Labeler: trifecta pharmaceuticals usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dibucaine
Generic Name dibucaine 1%
Labeler trifecta pharmaceuticals usa llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

dibucaine 1 g/100g

Manufacturer
Trifecta Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 69396-023
Product ID 69396-023_0df7b6dd-a4d8-c9a6-e063-6394a90a0f52
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2022-09-14

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69396023
Hyphenated Format 69396-023

Supplemental Identifiers

RxCUI
238784
UPC
0850026393415
UNII
L6JW2TJG99
NUI
N0000185508 N0000175629 N0000184306 M0000728

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 dibucaine (source: ndc)
Generic Name dibucaine 1% (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (69396-023-01) / 28.4 g in 1 TUBE
source: ndc

Packages (1)

69396-023-01 1 TUBE in 1 BOX (69396-023-01) / 28.4 g in 1 TUBE

Ingredients (1)

dibucaine (1 g/100g)

Linked Drug Pages (1)

Dibucaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0df7b6dd-a4d8-c9a6-e063-6394a90a0f52", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["0850026393415"], "unii": ["L6JW2TJG99"], "rxcui": ["238784"], "spl_set_id": ["e8a56651-a292-7609-e053-2a95a90a7c36"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Trifecta Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (69396-023-01)  / 28.4 g in 1 TUBE", "package_ndc": "69396-023-01", "marketing_start_date": "20220914"}], "brand_name": "Dibucaine", "product_id": "69396-023_0df7b6dd-a4d8-c9a6-e063-6394a90a0f52", "dosage_form": "OINTMENT", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "69396-023", "generic_name": "Dibucaine 1%", "labeler_name": "Trifecta Pharmaceuticals USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dibucaine", "active_ingredients": [{"name": "DIBUCAINE", "strength": "1 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220914", "listing_expiration_date": "20261231"}