dibucaine topical anesthetic 1% hemorrhoidal

Generic: dibucaine

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

Drug Facts

Product Profile

Brand Name dibucaine topical anesthetic 1% hemorrhoidal
Generic Name dibucaine
Labeler rugby laboratories inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

dibucaine 10 mg/g

Manufacturer
Rugby Laboratories Inc.

Identifiers & Regulatory

Product NDC 0536-1211
Product ID 0536-1211_364c388d-adc9-9763-e063-6294a90a77cd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2019-08-19

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 05361211
Hyphenated Format 0536-1211

Supplemental Identifiers

RxCUI
198601
UPC
0305361211950
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 topical anesthetic 1% hemorrhoidal (source: ndc)
Generic Name dibucaine (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (0536-1211-95) / 28 g in 1 TUBE
source: ndc

Packages (1)

0536-1211-95 1 TUBE in 1 BOX (0536-1211-95) / 28 g in 1 TUBE

Ingredients (1)

dibucaine (10 mg/g)

Linked Drug Pages (1)

Dibucaine Topical Anesthetic 1% Hemorrhoidal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "364c388d-adc9-9763-e063-6294a90a77cd", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["0305361211950"], "unii": ["L6JW2TJG99"], "rxcui": ["198601"], "spl_set_id": ["f23c8cd1-98f9-41cd-84d4-cf01c2ede29a"], "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": ["Rugby Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (0536-1211-95)  / 28 g in 1 TUBE", "package_ndc": "0536-1211-95", "marketing_start_date": "20190819"}], "brand_name": "Dibucaine Topical Anesthetic 1% Hemorrhoidal", "product_id": "0536-1211_364c388d-adc9-9763-e063-6294a90a77cd", "dosage_form": "OINTMENT", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "0536-1211", "generic_name": "DIBUCAINE", "labeler_name": "Rugby Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dibucaine Topical Anesthetic 1% Hemorrhoidal", "active_ingredients": [{"name": "DIBUCAINE", "strength": "10 mg/g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190819", "listing_expiration_date": "20261231"}