FDA.reportPublic FDA data

Medline

Product NDC
53329-919
11-digit product format
533290919
Labeler code
53329
Product ID
53329-919_3e6288db-68c6-ffaf-e063-6394a90a4eb4
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride, lidocain hydrochloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-01
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
.13; 4 g/100g; g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Medline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100g
LIDOCAINE HYDROCHLORIDE4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, V13007Z41A
Rxcui2047877

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53329-919-042025-09-10C16284748780-13b156c62-2fb6-fb37-e063-e6dba90a4e07919 Medline Burn Spray
53329-919-042025-07-29C16284748780-13b156c62-2fb6-fb37-e063-e6dba90a4e07919 Medline Burn Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-919-04Medline113 g in 1 BOTTLE, SPRAYSPRAY1136

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-919MEDLINE (BENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDE) SPRAY [MEDLINE INDUSTRIES, LP]5Current NDC, Legacy NDC, 1 package rows20241215_b0b5ff82-db36-7708-e053-2a95a90ad9bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SprayPSNb0b5ff82-db36-7708-e053-2a95a90ad9bb6
2047877benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical SpraySCDb0b5ff82-db36-7708-e053-2a95a90ad9bb6
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SpraySYb0b5ff82-db36-7708-e053-2a95a90ad9bb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-919-0453329091904113 g in 1 BOTTLE, SPRAY (53329-919-04) 113 g2021-05-010000-00-00NoNoCurrent