Home NDC 84847-540 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 Ingredient Strength BENZOCAINE 50 mg/mL BENZALKONIUM CHLORIDE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup F5UM2KM3W7 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84847-540-00 DEBACHERE Butt Balm After Care Antiseptic Pain Relief 3 mL in 1 PACKET CREAM 3 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84847-540 DEBACHERE BUTT BALM AFTER CARE ANTISEPTIC PAIN RELIEF (BENZOCAINE, BENZALKONIUM CHLORIDE) CREAM [DE.BACHERE USA LLC] 1 Current NDC, 1 package rows 20241031_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 48 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84847-540-00 84847054000 3 mL in 1 PACKET (84847-540-00) 3 ml 2024-09-27 No No Current