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 63 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4x Medicated Toothache and Gum CreamBENZOCAINEKrogera8c5090a-24f9-4e73-e053-2a95a90acca02025-11-14WarningsExact identifier
application number: M017
PM Toothache ReliefBENZOCAINECVS0a5a8cd0-d680-8a0f-e063-6294a90aa65c2025-11-14WarningsExact identifier
application number: M017
PM Toothache ReliefBENZOCAINEWalgreense816f742-fba9-3c12-e053-2a95a90a192f2025-11-14WarningsExact identifier
application number: M017
4x Medicated Toothache and Gum CreamBENZOCAINEWalgreensa71c2092-4ece-b82e-e053-2995a90ac9332025-11-14WarningsExact identifier
application number: M017
After Bite OutdoorDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands22b891a9-6386-dee1-e063-6394a90a5c2f2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger3f881349-fcdd-e276-e063-6394a90ae49e2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED434cb8b2-a996-5360-e063-6394a90ada032025-11-13WarningsExact identifier
application number: M017
Rapid ReliefCOLD RELIEF PATCH 5% MENTHOLRAPID AID VIET NAM COMPANY LIMITED4360e3ec-7a4b-b28e-e063-6294a90a0bd62025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MGRAPID AID VIET NAM COMPANY LIMITED4360e3be-0ec4-cd57-e063-6394a90aca632025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED43616ad7-58bb-e5ad-e063-6394a90a192b2025-11-13WarningsExact identifier
application number: M017
4x Medicated Severe Toothache and Gum GelBENZALKONIUM CHLORIDEMeijer97ce7890-5093-1763-e053-2a95a90afae72025-11-13WarningsExact identifier
application number: M017
Pain RelieverCAMPHOR, MENTHOLKool 'N Fit Inc.2253f6bd-5707-b993-e063-6394a90aa74a2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED4360e0d1-46cd-ab4b-e063-6394a90a55e12025-11-12WarningsExact identifier
application number: M017
CVS Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECVS8723e097-296f-784a-e053-2991aa0a552e2025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.154d8821-3e76-b0e2-e063-6294a90ae0772025-11-12WarningsExact identifier
application number: M017
Good neighbor Pharmacy Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEAMERISOURCEBERGEN DRUG CORPORATION87395273-380c-7cef-e053-2991aa0a54c62025-11-12WarningsExact identifier
application number: M017
Quality Choice Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEChain Drug Marketing Association8735b298-83f3-0b5d-e053-2a91aa0a82922025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.1550e794-b3c0-4769-e063-6294a90a8c2d2025-11-12WarningsExact 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