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 11 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Antibiotic	BACITRACIN ZINC	TARGET Corporation	4d8e7146-9215-417e-93be-af706502cfee	2025-07-07	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC PLUS PAIN RELIEF	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	GENOMMA LAB USA, INC.	506fcda5-df44-49c8-8dbd-cab7434b06b2	2025-07-02	Warnings	Exact identifier application number: M004
DG Poly Antibiotic First Aid Antibiotic	BACITRACIN AND POLYMYXIN B SULFATE	Dollar General	4d710928-5a7d-4f1a-aea0-be7fe599ae0c	2025-07-02	Warnings	Exact identifier application number: M004
Curad Maximum Strength Triple Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Medline Industries, LP	99e9c394-ebf1-7a27-e053-2a95a90ab157	2025-07-01	Warnings	Exact identifier application number: M004
Double Antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Sun Pharmaceutical Industries, Inc.	7e8af528-eb25-4f93-9b35-8fff635932cc	2025-07-01	Warnings	Exact identifier application number: M004
Triple Antibiotic plus Pain Relief Maximum Strength	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND PRAMOXINE HYDROCHLORIDE	Chain Drug Consortium, LLC	55ef2205-aaf1-4aa4-917f-2b4cfa43b77e	2025-07-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	RUGBY LABORATORIES	aa9f414e-d8de-417d-9ccd-027d5a5f5499	2025-06-27	Warnings	Exact identifier application number: M004
Meret Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	385d8642-9eae-a750-e063-6394a90a7931	2025-06-24	Warnings	Exact identifier application number: M004
ProCure Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Twin Med LLC	37a3916f-cc1a-41a0-e063-6394a90a35ed	2025-06-16	Warnings	Exact identifier application number: M004
Bacitracin Zinc	FIRST AID ANTIBIOTIC	Dynarex Corporation	82cf8dd0-eef6-5871-e053-2991aa0a38cf	2025-06-16	Warnings	Exact identifier application number: M004
Sion Biotext Bacitracin Zinc	BACITRACIN ZINC	Sion Biotext Medical Ltd	35056345-f325-99e8-e063-6294a90a2d7e	2025-06-12	Warnings	Exact identifier application number: M004
ProCure Bacitracin Zinc	BACITRACIN ZINC	Twin Med LLC	36da7993-7c65-7430-e063-6294a90a0626	2025-06-05	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, POLYMYXIN B	J&A Digital Inc.	9b8f2046-5886-440d-a7fc-a71138d7f34b	2025-06-02	Warnings	Exact identifier application number: M004
Lights Povidone Iodine Scrub	POVIDONE-IODINE	Lights Medical Manufacture Co., Ltd.	5e1eef53-c2c7-477e-9ee4-19c01c1881e5	2025-05-20	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN ZINC	Trifecta Pharmaceuticals USA, LLC.	4a9fe0fa-5549-4e06-e054-00144ff8d46c	2025-05-15	Warnings	Exact identifier application number: M004
SionBiotext Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Sion Biotext Medical Ltd	35083d42-5823-eeb1-e063-6294a90acafa	2025-05-13	Warnings	Exact identifier application number: M004
Multi Action	BACITRACINZINC,NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCL	Trifecta Pharmaceutical USA LLC	b98082f3-be95-49fb-e053-2a95a90a37b8	2025-05-13	Warnings	Exact identifier application number: M004
Leader Triple antibiotic and pain relief	BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE	Cardinal Health 110 dba LEADER	f4c521d9-dd05-1c23-e053-2995a90a6e2c	2025-05-13	Warnings	Exact identifier application number: M004
Tripleantibioticointmentandpainrelief	BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE	Trifecta Pharmaceuticals USA	34f1db74-6506-d53d-e063-6394a90ac400	2025-05-12	Warnings	Exact identifier application number: M004
Triple Antibiotic plus Lidocaine	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE, LIDOCAINE	TRIFECTA PHARMACEUTICALS USA LLC	14fda967-54ba-c964-e063-6294a90a21ee	2025-04-24	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