El Valle Merthiolate

Product NDC: 55758-375
11-digit product format: 557580375
Labeler code: 55758
Product ID: 55758-375_4df13d29-3a69-c83a-e063-6394a90a393f
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: LIQUID
Route: TOPICAL
Labeler: Pharmadel LLC
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-05-31
Substance: BENZALKONIUM CHLORIDE
Active strength: 1.3 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55758-375	55758-375-01	D	Discontinued by firm		2026-10-16

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: El Valle Merthiolate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	1.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
1049254	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
fd7b28ca-9f71-0ff6-e053-6394a90a4822	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55758-375-01	El Valle Merthiolate	15 mL in 1 BOTTLE, PLASTIC	LIQUID	15		6
55758-375-02	El Valle Merthiolate	30 mL in 1 BOTTLE	LIQUID	30		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55758-375	EL VALLE MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [PHARMADEL LLC]	3	Current NDC, 2 package rows	20241120_fd7b28ca-9f71-0ff6-e053-6394a90a4822.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 20 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Triple Antibiotic	FIRST AID TRIPLE ANTIBIOTIC	Cardinal Health 110,Inc.	844cd9a1-b68e-47d8-a5eb-c9e880ba019e	2024-01-18	Warnings	Exact identifier application number: M004
Multi-Action Antibiotic and Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE OINTMENT	Target Corporation	8fecff32-bd67-4351-90f7-0c28cb335ea3	2024-01-18	Warnings	Exact identifier application number: M004
Leader Poly Bacitracin	FIRST AID ANTIBIOTIC	Cardinal Health 110, Inc.	442e11aa-7d14-44f9-bf14-446018f1de0d	2024-01-18	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	7b16cb9b-5847-4360-9974-2118f4a2c70f	2024-01-17	Warnings	Exact identifier application number: M004
Green Guard Triple Antibiotic	BACITRACIN ZIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	bd456e2f-e6d7-d2ad-e053-2995a90a5c12	2024-01-17	Warnings	Exact identifier application number: M004
Medi-First Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	bd432abc-fefb-1b4b-e053-2995a90acb18	2024-01-17	Warnings	Exact identifier application number: M004
Crane Safety Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Crane Safety LLC	96dbc282-4b3f-aaf3-e053-2995a90a5694	2024-01-17	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Target Corporation	10c4a1b5-bb91-48da-b0ae-303e4adf793a	2024-01-17	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC	Target Corporation	6020956d-2f58-4be8-97da-3f6b7e0f34aa	2024-01-17	Warnings	Exact identifier application number: M004
Triple Antibiotic and Pain Relief	TRIPLE ANTIBIOTIC	Target Corporation	8fda7b8a-72f3-4b92-a229-ac5be0e3b3eb	2024-01-17	Warnings	Exact identifier application number: M004
Travel Savvy First Aid Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Bellegrove Medical Supply, Inc.	69fa1c9d-5e6d-4593-e053-2a91aa0a7690	2024-01-16	Warnings	Exact identifier application number: M004
American Safety First Aid Antispetic	ISOPROPYL ALCOHOL	Orazen Inc	ea302ba4-a63d-e713-e053-2995a90a3fc4	2024-01-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Sled Distribution, LLC	e7398df8-8e23-5439-e053-2a95a90ac3aa	2024-01-15	Warnings	Exact identifier application number: M004
ER Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	EVER READY FIRST AID	20f97e1c-584f-4844-afd8-8641ffe2f466	2024-01-11	Warnings	Exact identifier application number: M004
Lightning X Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	0e66af91-e0b4-827f-e063-6294a90a9847	2024-01-07	Warnings	Exact identifier application number: M004
triple antibiotic 01	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	0e1b23f3-fa1e-f42b-e063-6394a90a3bec	2024-01-04	Warnings	Exact identifier application number: M004
Triple Antibiotic Ointment, Circle K	TRIPLE ANTIBIOTIC	Lil' Drug Store products, Inc.	0d98477b-aa33-ebb7-e063-6294a90a597f	2024-01-03	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Trifecta Pharmaceuticals USA LLC	d9f2702c-a514-cb69-e053-2a95a90a29a9	2024-01-02	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	Geri-Care Pharmaceuticals, Corp	ef309620-1cf9-d007-e053-2995a90ad46f	2024-01-02	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Geri-Care Pharmaceuticals, Corp.	eec90f72-fd13-05c9-e053-2995a90a642a	2024-01-02	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049254	benzalkonium chloride 0.13 % Topical Solution	PSN	fd7b28ca-9f71-0ff6-e053-6394a90a4822	6
1049254	benzalkonium chloride 1.3 MG/ML Topical Solution	SCD	fd7b28ca-9f71-0ff6-e053-6394a90a4822	6
1049254	benzalkonium chloride 0.13 % Topical Solution	SY	fd7b28ca-9f71-0ff6-e053-6394a90a4822	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55758-375-01	55758037501	15 mL in 1 BOTTLE, PLASTIC	15 ml				Historical
55758-375-02	55758037502	30 mL in 1 BOTTLE (55758-375-02)	30 ml	2023-05-31	No	No	Current