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: LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Active strength: 4; .13 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 date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	53329-919		I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-919	53329-919-04	I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`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
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	4 g/100g
BENZALKONIUM CHLORIDE	.13 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V13007Z41A	Internal UNII lookup
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b0b5ff82-db36-7708-e053-2a95a90ad9bb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53329-919-04	2025-09-10	C162847	48780-1	3b156c62-2fb6-fb37-e063-e6dba90a4e07	919 Medline Burn Spray
53329-919-04	2025-07-29	C162847	48780-1	3b156c62-2fb6-fb37-e063-e6dba90a4e07	919 Medline Burn Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-919-04	Medline	113 g in 1 BOTTLE, SPRAY	SPRAY	113		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-919	MEDLINE (BENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDE) SPRAY [MEDLINE INDUSTRIES, LP]	5	Current NDC, Legacy NDC, 1 package rows	20241215_b0b5ff82-db36-7708-e053-2a95a90ad9bb.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 2 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walmart	ISOPROPYL ALCOHOL	Walmart, Inc.	2eff98ba-5736-b07e-e063-6394a90aeea9	2026-09-04	Warnings	Exact identifier application number: M003
Walgreen Alcohol	ISOPROPYL ALCOHOL	Walgreens Company	deeae1ea-3d81-4260-95be-c4f328e3fdef	2026-09-04	Warnings	Exact identifier application number: M003
Dollar General	ISOPROPYL ALCOHOL	Dollar General Corporation	00b2ef34-42d9-523c-e063-6294a90a753d	2026-09-03	Warnings	Exact identifier application number: M003
Signature Select Alcohol Prep Pads	ISOPROPYL ALCOHOL	Better Living Brands LLC	31ce72e3-03a3-1608-e063-6394a90ad850	2026-09-03	Warnings	Exact identifier application number: M003
SurviveX Sting Relief	STING RELIEF WIPE	Changzhou Maokang Medical Products Co., Ltd.	5a83b1f1-c8dc-cf07-e063-6394a90a20ca	2026-09-03	Warnings	Exact identifier application number: M003
Benzethonium chloride Plus Dyclonine hydrochloride	LIQUID BANDAGE	Kroger Co.	fe604470-917f-4cbd-a1e6-ac1dc7c57ff6	2026-09-02	Warnings	Exact identifier application number: M003
Alcohol	ISOPROPYL ALCOHOL	Rite Aid Corporation	5104f9ab-0b28-449f-a55a-5438713a24df	2026-09-02	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	UpLift Brands, LLC	5a81b635-d188-0b29-e063-6294a90a1e4b	2026-09-02	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	CVS Pharmacy, Inc.	7f518646-c8fe-499a-b5e4-8e5a5a90e01d	2026-09-02	Warnings, Adverse reactions	Exact identifier application number: M003
Alcohol	ISOPROPYL ALCOHOL	The Kroger Company	6551187f-5cde-4149-931f-b057bd760750	2026-09-02	Warnings	Exact identifier application number: M003
Unscented NasalGuard Antiseptic Topical	BENZALKONIUM CHLORIDE	TRUTEK CORP.	eb036e11-a28c-fdc0-e053-2a95a90a9cdb	2026-09-02	Warnings	Exact identifier application number: M003
Harris Teeter	ISOPROPYL ALCOHOL	Harris Teeter, LLC	d2bb20bd-ec83-8d80-e053-2a95a90a2bba	2026-09-02	Warnings	Exact identifier application number: M003
School Health	ISOPROPYL ALCOHOL	School Health Corporation	db5d0b22-f2d7-23e5-e053-2a95a90aeb51	2026-09-02	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Topco Associates	2642298f-607e-fdca-e063-6394a90a69d9	2026-09-02	Warnings	Exact identifier application number: M003
HUSTLE BUTTER NUMBING	LIDOCAINE HCL, BENZALKONIUM CHLORIDE	H.B.D. DIST. INC.	5b4d0390-dac6-4a71-9fdc-5c31543e7c5a	2026-09-02	Warnings	Exact identifier application number: M003
NasalGuard Antiseptic Topical Cool Menthol	BENZALKONIUM CHLORIDE	TRUTEK CORP.	e9fd3ef8-78ff-6c9f-e053-2a95a90a21a8	2026-09-01	Warnings	Exact identifier application number: M003
Maximum Strength Betadine Clear	BENZALKONIUM CL AND PRAMOXINE HCL	Atlantis Consumer Healthcare, Inc.	31b94a76-1536-47c0-ab03-e487c2625c58	2026-08-31	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a28101f-ea8e-6071-e063-6294a90aad91	2026-08-31	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a3e62ce-52dc-121b-e063-6294a90a898f	2026-08-31	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a49db18-c270-6f46-e063-6294a90afb5d	2026-08-31	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2047877	benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical Spray	PSN	b0b5ff82-db36-7708-e053-2a95a90ad9bb	6
2047877	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical Spray	SCD	b0b5ff82-db36-7708-e053-2a95a90ad9bb	6
2047877	benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical Spray	SY	b0b5ff82-db36-7708-e053-2a95a90ad9bb	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-919-04	53329091904	113 g in 1 BOTTLE, SPRAY (53329-919-04)	113 g	2021-05-01	0000-00-00	No	No	Current