dibucaine

Generic: dibucaine

Labeler: akron pharma inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dibucaine
Generic Name dibucaine
Labeler akron pharma inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

dibucaine .28 g/28g

Manufacturer
Akron Pharma Inc.

Identifiers & Regulatory

Product NDC 71399-2829
Product ID 71399-2829_da90939a-75f0-4b82-94ff-8611fe746715
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2025-01-06

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 713992829
Hyphenated Format 71399-2829

Supplemental Identifiers

RxCUI
238784
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 (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .28 g/28g
source: ndc
Packaging
  • 28 g in 1 TUBE (71399-2829-1)
  • 1 TUBE in 1 PACKAGE (71399-2829-2) / 56 g in 1 TUBE
source: ndc

Packages (2)

71399-2829-1 28 g in 1 TUBE (71399-2829-1) 71399-2829-2 1 TUBE in 1 PACKAGE (71399-2829-2) / 56 g in 1 TUBE

Ingredients (1)

dibucaine (.28 g/28g)

Linked Drug Pages (1)

Dibucaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "da90939a-75f0-4b82-94ff-8611fe746715", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["L6JW2TJG99"], "rxcui": ["238784"], "spl_set_id": ["60469e43-ab6f-46d3-a1df-00e58275f565"], "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": ["Akron Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 g in 1 TUBE (71399-2829-1)", "package_ndc": "71399-2829-1", "marketing_start_date": "20250106"}, {"sample": false, "description": "1 TUBE in 1 PACKAGE (71399-2829-2)  / 56 g in 1 TUBE", "package_ndc": "71399-2829-2", "marketing_start_date": "20250106"}], "brand_name": "Dibucaine", "product_id": "71399-2829_da90939a-75f0-4b82-94ff-8611fe746715", "dosage_form": "OINTMENT", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "71399-2829", "generic_name": "Dibucaine", "labeler_name": "Akron Pharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dibucaine", "active_ingredients": [{"name": "DIBUCAINE", "strength": ".28 g/28g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250106", "listing_expiration_date": "20261231"}