FDA.reportPublic FDA data

DEBACHERE Butt Balm After Care Antiseptic Pain Relief

Product NDC
84847-540
11-digit product format
848470540
Labeler code
84847
Product ID
84847-540_259f4642-0f3c-907c-e063-6294a90a3491
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE, BENZALKONIUM CHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
DE.BACHERE USA LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-27
Substance
BENZOCAINE; BENZALKONIUM CHLORIDE
Active strength
50; 1 mg/mL; mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
DEBACHERE Butt Balm After Care Antiseptic Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE50 mg/mL
BENZALKONIUM CHLORIDE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
F5UM2KM3W7Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ba42864-69bf-455c-98d4-7f4ff94edcebAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84847-540-00DEBACHERE Butt Balm After Care Antiseptic Pain Relief3 mL in 1 PACKETCREAM31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84847-540DEBACHERE BUTT BALM AFTER CARE ANTISEPTIC PAIN RELIEF (BENZOCAINE, BENZALKONIUM CHLORIDE) CREAM [DE.BACHERE USA LLC]1Current NDC, 1 package rows20241031_8ba42864-69bf-455c-98d4-7f4ff94edceb.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 53 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZIMS MAX FREEZELIDOCAINE HYDROCHLORIDE AND MENTHOL,KOBAYASHI Healthcare International, Inc.e364ff83-4aaf-4897-a7da-06581bc321f22025-12-18WarningsExact identifier
application number: M017
Tiger Balm White Regular StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.f406161e-a9c4-47d1-8b21-93b1b79380632025-12-17WarningsExact identifier
application number: M017
ResinolPETROLATUM AND RESORCINOLResiCal, Inc.03f57a4a-f94b-4ba6-b709-41cfb6e162612025-12-17WarningsExact identifier
application number: M017
HealthWise Maximum Pain ReliefLIDOCAINEVeridian Healthcareafc3c16d-0076-44b2-ae7e-5f36d4d8088e2025-12-17WarningsExact identifier
application number: M017
HealthWise Max Lidocaine plus MentholLIDOCAINE, MENTHOLVeridian Healthcaref39a27da-6799-4fc6-97ca-101eac4a93602025-12-17WarningsExact identifier
application number: M017
HealthWise Original MentholMENTHOLVeridian Healthcaree4bfb6b0-545e-4fbc-8538-4f41a6be10252025-12-17WarningsExact identifier
application number: M017
Welly Polka First Aid KitHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEDongguan Shenglian Tins Products Co., Ltd.d7c4314c-c4c6-4adf-b384-3ac7a71083192025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Arthritis Pain TherapyMENTHOLWise Consumer Products2410a199-f4a3-da6c-e063-6394a90aaace2025-12-17WarningsExact identifier
application number: M017
LidocaineLIDOCAINE, MENTHOLVive Health LLC462d3b24-643e-91da-e063-6394a90a0e1d2025-12-17WarningsExact identifier
application number: M017
TheragesicMETHYL SALICYLATEMission Pharmacal Companydb6c0c77-0a20-d574-a98f-e6c9998b941f2025-12-17WarningsExact identifier
application number: M017
Teevodar Pain RelievingMENTHOLSod-e Biotech Ltd205b0fef-4f00-db2e-e063-6294a90a93b82025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Arthritis Pain ReliefMENTHOLWISE CONSUMER PRODUCTS CO.116045df-891b-f370-e063-6294a90abe422025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Intensive Foot TherapyMENTHOLWise Consumer Products23e56c6b-0f2b-721f-e063-6394a90a1ed02025-12-17WarningsExact identifier
application number: M017
Tiger Balm Ultra StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.f0561804-e0f7-495d-9768-9b86a208c51e2025-12-17WarningsExact identifier
application number: M017
Kwan LoongMETHYL SALICYLATE AND MENTHOLHaw Par Healthcare Ltd.54bcb26e-786a-403e-9330-11ae9e3c013a2025-12-17WarningsExact identifier
application number: M017
Magsoothium Body Cooling FormulaMENTHOLUbu/Elements, Inc.f7fb6ac9-a920-a440-e053-6394a90aaa352025-12-16WarningsExact identifier
application number: M017
Magsoothium CBD Body LavenderMENTHOLUbu/Elements, Inc.f9b87fbe-b889-67a1-e053-6394a90acbcd2025-12-16WarningsExact identifier
application number: M017
Aquaphor Itch ReliefHYDROCORTISONEBeiersdorf Incb1d0333f-ba60-35d8-e053-2995a90af9322025-12-16WarningsExact identifier
application number: M017
Magsoothium CBD BodyMENTHOLUbu/Elements, Inc.00b2ef34-42d7-523c-e063-6294a90a753d2025-12-16WarningsExact identifier
application number: M017
GENTLECARE HAND AND SKIN SANITIZERBENZALKONIUM CHLORIDEPARAGON SOLUTIONS US, INC.16650277-fa62-485e-9a82-7763d2b501682025-12-16WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84847-540-00848470540003 mL in 1 PACKET (84847-540-00) 3 ml2024-09-27NoNoCurrent