Benzocaine

Product NDC
84415-044
11-digit product format
844150044
Labeler code
84415
Product ID
84415-044_2bc582da-83f3-1644-e063-6294a90a8968
Type
HUMAN OTC DRUG
Nonproprietary name
Topical Anesthetic
Dosage form
SPRAY
Route
DENTAL; PERIODONTAL
Labeler
Everpharm LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-15
Substance
BENZOCAINE
Active strength
200 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
Benzocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui360348

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84415-044-01Benzocaine1 in 1 POUCHSPRAY11
84415-044-01Benzocaine25 in 1 PACKAGESPRAY251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84415-044-01EA - Each84415-044fe963d92-91de-4a01-8f84-dbc954d24cb712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84415-044BENZOCAINE (TOPICAL ANESTHETIC) SPRAY [EVERPHARM LLC]1Current NDC, 2 package rows20250117_2bc57111-0f15-b237-e063-6294a90a4471.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
360348benzocaine 20 % Mucosal SprayPSN2bc57111-0f15-b237-e063-6294a90a44711
360348benzocaine 200 MG/ML Mucosal SpraySCD2bc57111-0f15-b237-e063-6294a90a44711
360348benzocaine 20 % Mucosal SpraySY2bc57111-0f15-b237-e063-6294a90a44711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84415-044-018441500440125 POUCH in 1 PACKAGE (84415-044-01) / 1 APPLICATOR in 1 POUCH / .5 mL in 1 APPLICATOR25 pouch2025-01-15NoNoHistorical