DEBACHERE Butt Balm After Play Care Multi Symptoms Relief

Product NDC
84847-940
11-digit product format
848470940
Labeler code
84847
Product ID
84847-940_30863aba-b647-6eff-e063-6294a90a9d42
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
2025-03-11
Substance
BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength
10; 50 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

Additional Listing Data#

Finished product
Yes
Brand name base
DEBACHERE Butt Balm After Play Care Multi Symptoms Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE10 mg/mL
BENZOCAINE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, U3RSY48JW5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84847-940-00DEBACHERE Butt Balm After Play Care Multi Symptoms Relief3 mL in 1 PACKETCREAM31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84847-940DEBACHERE BUTT BALM AFTER PLAY CARE MULTI SYMPTOMS RELIEF (BENZOCAINE, BENZALKONIUM CHLORIDE) CREAM [DE.BACHERE USA LLC]1Current NDC, 1 package rows20250319_f469b446-58a0-4be3-884f-d622b9d074f8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84847-940-00848470940003 mL in 1 PACKET (84847-940-00) 3 ml2025-03-11NoNoCurrent