debachere butt balm after care antiseptic pain relief

Generic: benzocaine, benzalkonium chloride

Labeler: de.bachere usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name debachere butt balm after care antiseptic pain relief
Generic Name benzocaine, benzalkonium chloride
Labeler de.bachere usa llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

benzalkonium chloride 1 mg/mL, benzocaine 50 mg/mL

Manufacturer
DE.BACHERE USA LLC

Identifiers & Regulatory

Product NDC 84847-540
Product ID 84847-540_259f4642-0f3c-907c-e063-6294a90a3491
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2024-09-27

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 84847540
Hyphenated Format 84847-540

Supplemental Identifiers

UPC
0197644608447
UNII
F5UM2KM3W7 U3RSY48JW5
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 debachere butt balm after care antiseptic pain relief (source: ndc)
Generic Name benzocaine, benzalkonium chloride (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
  • 50 mg/mL
source: ndc
Packaging
  • 3 mL in 1 PACKET (84847-540-00)
source: ndc

Packages (1)

84847-540-00 3 mL in 1 PACKET (84847-540-00)

Ingredients (2)

benzalkonium chloride (1 mg/mL) benzocaine (50 mg/mL)

Linked Drug Pages (1)

DEBACHERE Butt Balm After Care Antiseptic Pain Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "259f4642-0f3c-907c-e063-6294a90a3491", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["0197644608447"], "unii": ["F5UM2KM3W7", "U3RSY48JW5"], "spl_set_id": ["8ba42864-69bf-455c-98d4-7f4ff94edceb"], "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": ["DE.BACHERE USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 mL in 1 PACKET (84847-540-00)", "package_ndc": "84847-540-00", "marketing_start_date": "20240927"}], "brand_name": "DEBACHERE Butt Balm After Care Antiseptic Pain Relief", "product_id": "84847-540_259f4642-0f3c-907c-e063-6294a90a3491", "dosage_form": "CREAM", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "84847-540", "generic_name": "BENZOCAINE, BENZALKONIUM CHLORIDE", "labeler_name": "DE.BACHERE USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DEBACHERE Butt Balm After Care Antiseptic Pain Relief", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": "1 mg/mL"}, {"name": "BENZOCAINE", "strength": "50 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240927", "listing_expiration_date": "20261231"}