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		2026-10-15

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 9 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antibiotic Maximum Strength	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Walgreens	9a092f24-65b2-4b57-8103-265ea3e03311	2025-09-02	Warnings	Exact identifier application number: M004
Aerosoothe	TRIPLE ANTIBIOTIC OINTMENT	Aero Healthcare US LLC	2287a31c-750c-728d-e054-00144ff88e88	2025-08-29	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Chain Drug Marketing Association Inc.	3d4b3d73-171a-bc6a-e063-6394a90a69c1	2025-08-26	Warnings	Exact identifier application number: M004
Dual Action Cream	NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCL	Trifecta Pharmaceutical USA LLC	b84015ae-9c76-b1d7-e053-2a95a90a2cc8	2025-08-23	Warnings	Exact identifier application number: M004
Natureplex Antibiotic Plus Pain, Itch, Scar Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Natureplex LLC	f0af8829-72fb-46b1-9328-6f4920710bb1	2025-08-15	Warnings	Exact identifier application number: M004
PROHEAL TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	6c61d88e-4ced-4468-8f99-91652f7a03e4	2025-08-13	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	J&A Digital Inc.	9f006f16-083d-4e95-aec2-6ef83405f393	2025-08-07	Warnings	Exact identifier application number: M004
Vitacilina First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Taisho Pharmaceutical California Inc.	93fb9e05-f78c-4d37-b6f1-926cbcb2e7a7	2025-08-07	Warnings	Exact identifier application number: M004
SurviveX Triple Antibiotic	TRIPLE ANTIBIOTIC OINTMENT	Nantong Health & Beyond Hygienic Products Inc.	3bd25bb6-6486-8a0a-e063-6394a90a085c	2025-08-07	Warnings	Exact identifier application number: M004
Thera Plus Original Strength Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	FOURSTAR GROUP USA, INC.	09e8bdb7-dc14-4f28-8306-c0e2bf73f081	2025-07-31	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Bryant Ranch Prepack	0c081802-429f-468f-9650-293cb7a1ad34	2025-07-29	Warnings	Exact identifier application number: M004
health and .beyond Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	0070ea5f-434d-53a7-e063-6294a90abf18	2025-07-27	Warnings	Exact identifier application number: M004
health and beyond TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	13cbe416-a146-447d-be36-8b3af9b3c895	2025-07-27	Warnings	Exact identifier application number: M004
AOSI HEALTHCARE TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	70c53369-7cf6-4352-a19f-c85a55c5a4bd	2025-07-27	Warnings	Exact identifier application number: M004
Pomada de Sulfa	NEOMYCIN SULFATE	Menper Distributors, Inc.	216f4d22-e5e8-46c8-a4ef-8d1532792b56	2025-07-22	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	STRATEGIC SOURCING SERVICES LLC	1bda9c30-8fc8-4814-b211-94550672b22f	2025-07-21	Warnings	Exact identifier application number: M004
Triple Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	6a61c900-2dfc-4c07-8ae5-32ffbd89d2b6	2025-07-21	Warnings	Exact identifier application number: M004
FifthPulse Bacitracin Zinc 1oz	BACITRACIN ZINC	Front Pharmaceutical PLC	39f994d4-5f41-fb34-e063-6294a90a45ea	2025-07-15	Warnings	Exact identifier application number: M004
FifthPulse Bacitracin Zinc 4oz	BACITRACIN ZINC	Front Pharmaceutical PLC	39fa0e5f-b794-e1e3-e063-6394a90a4ce3	2025-07-15	Warnings	Exact identifier application number: M004
FifthPulse Hydrocortisone 1oz	HYDROCORTISONE	Front Pharmaceutical PLC	39fae2a4-902e-3c88-e063-6394a90acbd5	2025-07-15	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