El Valle Decolorized Iodine

Product NDC: 55758-374
11-digit product format: 557580374
Labeler code: 55758
Product ID: 55758-374_45264d78-173c-fa9d-e063-6294a90ae983
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: TINCTURE
Route: TOPICAL
Labeler: Pharmadel LLC
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-05-31
Marketing end: 2027-08-01
Substance: ALCOHOL
Active strength: .48 mg/mL
NDC exclude flag: No
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	55758-374	55758-374-01	D	Discontinued by firm		2026-10-21

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 Decolorized Iodine

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	.48 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
fd7a227b-536c-b3f7-e053-6394a90a4158	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55758-374-01	El Valle Decolorized Iodine	15 mL in 1 BOTTLE, PLASTIC	TINCTURE	15		4
55758-374-02	El Valle Decolorized Iodine	30 mL in 1 BOTTLE, PLASTIC	TINCTURE	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55758-374	EL VALLE DECOLORIZED IODINE (ALCOHOL) TINCTURE [PHARMADEL LLC]	3	Current NDC, 2 package rows	20241120_fd7a227b-536c-b3f7-e053-6394a90a4158.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 10 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Fred's, Inc.	41ee7a50-d36b-4214-b6f8-44f47ab44a84	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Lidl US, LLC	98389314-c2cf-4510-ab3d-41c4c4720019	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B	Publix Super Markets Inc	72bdb96c-af93-4a9b-93d9-81a94b6ff756	2025-07-15	Warnings	Exact identifier application number: M004
Live Better Triple Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	The Great Atlantic & Pacific Tea Company	7e7a0b4c-67a9-42f3-aacd-2606fde25090	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Topco Associates LLC	55a8a52c-4d03-417d-9283-406f6879bcb5	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	FRED'S, INC.	a44db5d1-7a74-44aa-9aa7-6247e771aaf2	2025-07-15	Warnings	Exact identifier application number: M004
Shopko Triple Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Shopko Stores Operating Co., LLC	5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa	2025-07-15	Warnings	Exact identifier application number: M004
sunmark triple antibiotic plus pain relief	POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services LLC	941a6a71-e898-4af3-989a-6d3aa3224338	2025-07-15	Warnings	Exact identifier application number: M004
TopCare Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	0fc0dbc6-ca1d-42be-8016-68e64f119706	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Walgreen Company	e2b7fc5b-c796-4ed1-aea7-4c810df250d5	2025-07-15	Warnings	Exact identifier application number: M004
Publix antibiotic plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Publix Super Markets Inc	d0193bf1-a257-490e-a058-5e6a514981da	2025-07-15	Warnings	Exact identifier application number: M004
Live Better Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	The Great Atlantic & Pacific Tea Company	7d3435ad-7d73-4db6-8019-3040b3dadfa9	2025-07-14	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Wal-Mart Stores, Inc.	f5199476-1ce2-4a82-9685-40d78b7a8935	2025-07-14	Warnings	Exact identifier application number: M004
Double Antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	STRATEGIC SOURCING SERVICES LLC	38414fff-8dad-44d0-9dfa-f89a63ef9b44	2025-07-14	Warnings	Exact identifier application number: M004
sunmark double antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Strategic Sourcing Services LLC	2868de5c-4894-45ee-9647-9acd3bde7cfc	2025-07-14	Warnings	Exact identifier application number: M004
Live Better Bacitracin Zinc	BACITRACIN ZINC	The Great Atlantic & Pacific Tea Company	6915940c-2eae-445c-ba58-e39d221e9d3d	2025-07-11	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	STRATEGIC SOURCING SERVICES LLC	4594948d-1f25-4d3c-a615-9e6edda05a10	2025-07-11	Warnings	Exact identifier application number: M004
Good Neighbor Pharmacy Bacitracin Zinc	BACITRACIN ZINC	AmerisourceBergen	3fb302b5-7273-412c-a2ba-b76183e3f179	2025-07-11	Warnings	Exact identifier application number: M004
TopCare Bacitracin Zinc	BACITRACIN ZINC	Topco Associates LLC	5b59e26d-cc25-49a6-ac8b-f79398e18f2d	2025-07-07	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC	TARGET Corporation	4d8e7146-9215-417e-93be-af706502cfee	2025-07-07	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55758-374-01	55758037401	15 mL in 1 BOTTLE, PLASTIC	15 ml					Historical
55758-374-02	55758037402	30 mL in 1 BOTTLE, PLASTIC (55758-374-02)	30 ml	2023-05-31	2027-08-01	No	No	Historical