FDA.reportPublic FDA data

Medline

Product NDC
53329-918
11-digit product format
533290918
Labeler code
53329
Product ID
53329-918_414bb528-1926-c545-e063-6394a90ad391
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct53329-918IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-91853329-918-04IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
Medline
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2047877Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b1059e68-b240-056c-e053-2995a90a61b2Available on FDA.report

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
53329-918-042025-07-29C16284748780-13b156c62-3453-fb37-e063-e6dba90a4e07918 Medline Cleansing Spray
53329-918-042025-07-29C16284748780-13b156c62-3453-fb37-e063-e6dba90a4e07918 Medline Cleansing Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-918-04Medline113 g in 1 BOTTLE, SPRAYSPRAY1136

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-918MEDLINE (BENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDE) SPRAY [MEDLINE INDUSTRIES, LP]5Current NDC, Legacy NDC, 1 package rows20241213_b1059e68-b240-056c-e053-2995a90a61b2.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 112 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Septihol Hand SanitizerALCOHOLSTERIS Corporation279c5c6f-bf45-499f-a5a2-ddb5353821462023-12-06WarningsExact identifier
application number: M003
Zany Antiseptic GelALCOHOLLaboratorios Zepol S.A.ee085cb5-0ebf-498c-b622-b2c29d34bb9b2023-12-01WarningsExact identifier
application number: M003
Prep Pad SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd758abf53-ad8a-62ac-e053-2991aa0a8f0c2023-11-15WarningsExact identifier
application number: M003
FIRSTAR Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.49a86020-b888-423f-99a5-02fa938105ec2023-11-15WarningsExact identifier
application number: M003
CVS Health Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Health4678074a-16f1-5480-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M003
Care One 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLAhold U.S.A., Inc.607b6917-2880-4b1c-83c6-f1297a828ecc2023-11-10WarningsExact identifier
application number: M003
Topcare 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDETopco Associates LLCdc4b07b6-6476-4e32-901a-da8115d6a1972023-11-10WarningsExact identifier
application number: M003
Topcare 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLTopco Associates LLCbf9ee7da-69d9-47a2-8748-6b978ca3c2982023-11-10WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd40c7cfc6-ef3b-4759-b9e9-6d7e1319a8472023-11-09WarningsExact identifier
application number: M003
BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdfe5eb694-4b1b-4c47-95d5-6074155c438a2023-11-09WarningsExact identifier
application number: M003
Leader Alcohol 70 Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health4b5d50cb-a8b4-4997-a8dd-26506c4cdc6d2023-11-09WarningsExact identifier
application number: M003
BZK Cleansing Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd52c74f75-d7ef-481b-b580-fba402d03d752023-11-09WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd48d198f0-d505-4e45-b7c9-dd70658fd5fa2023-11-09WarningsExact identifier
application number: M003
Maokang 3 Hydrogen PeroxideHYDROGEN PEROXIDEChangzhou Maokang Medical Products Co., Ltdb4b478b9-426d-4864-a64c-31de9bbf5dc32023-11-09WarningsExact identifier
application number: M003
MK Sting Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1a60dd1b-0116-42a2-a501-4f74e326a2e92023-11-09WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn Care KitHEXYLRESORCINOLAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions5ddb84e9-cdf7-4034-acd2-625f8d6e46012023-11-08WarningsExact identifier
application number: M003
Inverness Ear PiercingBENZALKONIUM CHLORIDEThe Richline Group, Inc.bcec8099-939b-4cff-b388-f4046164f2d42023-11-08WarningsExact identifier
application number: M003
Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.98b70f22-cd53-e61b-e053-2995a90a730d2023-11-06WarningsExact identifier
application number: M003
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLDegasa, S.A. de C.V.b4145aa4-d810-4c20-8493-311a7e222eb92023-11-05WarningsExact identifier
application number: M003
HYDROGEN PEROXIDEHYDROGEN PEROXIDEDEGASA SA DE CV26bae595-6e76-4946-b98f-1aba2e69250d2023-11-05WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SprayPSNb1059e68-b240-056c-e053-2995a90a61b26
2047877benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical SpraySCDb1059e68-b240-056c-e053-2995a90a61b26
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SpraySYb1059e68-b240-056c-e053-2995a90a61b26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-918-0453329091804113 g in 1 BOTTLE, SPRAY (53329-918-04) 113 g2021-05-010000-00-00NoNoCurrent