Antiseptic

Product NDC
73598-0681
11-digit product format
735980681
Labeler code
73598
Product ID
73598-0681_a41dcb58-7a0a-45b4-9cd3-37ecf8906b38
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride, benzocaine
Dosage form
SPRAY
Route
TOPICAL
Labeler
JHK Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-14
Substance
BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength
100; 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
Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE100 mg/mL
BENZOCAINE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, U3RSY48JW5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73598-0681-12024-05-07C16284748780-1d6a99b39-d443-a426-e053-dadaa90af4c20ac5d890-c262-4a30-9fd8-2de6cb0f7601
73598-0681-12022-01-28C16284748780-1d6a99b39-d443-a426-e053-dadaa90af4c20ac5d890-c262-4a30-9fd8-2de6cb0f7601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73598-0681-1Antiseptic59.1 mL in 1 BOTTLE, SPRAYSPRAY59.12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73598-0681ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [JHK INC]2Current NDC, Legacy NDC, 1 package rows20240509_0ac5d890-c262-4a30-9fd8-2de6cb0f7601.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73598-0681-17359806810159.1 mL in 1 BOTTLE, SPRAY (73598-0681-1) 59.1 ml2020-02-140000-00-00NoNoCurrent