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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55758-37455758-374-01DDiscontinued by firm2026-10-21

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
IngredientStrength
ALCOHOL.48 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd7a227b-536c-b3f7-e053-6394a90a4158Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-374-01El Valle Decolorized Iodine15 mL in 1 BOTTLE, PLASTICTINCTURE154
55758-374-02El Valle Decolorized Iodine30 mL in 1 BOTTLE, PLASTICTINCTURE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-374EL VALLE DECOLORIZED IODINE (ALCOHOL) TINCTURE [PHARMADEL LLC]3Current NDC, 2 package rows20241120_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 15 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neosporin Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC32302dcd-f3f1-408b-ae5f-e7d8b666f68f2024-11-13WarningsExact identifier
application number: M004
NEOSPORIN Plus BURN RELIEFBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC3caa7fd1-bd66-427e-a6c0-1b137b2050892024-11-13WarningsExact identifier
application number: M004
Simply Neosporin First Aid AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEKenvue Brands LLC68bfecea-095f-4d3f-b077-d86e1b9f1faa2024-11-13WarningsExact identifier
application number: M004
Triple Antibiotic and Burn ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDECVS Pharmacyfdc510b8-f3ad-4bd6-a8d0-1b81e9f30e132024-11-13WarningsExact identifier
application number: M004
BACITRACINBACITRACINALLIED TRADE LINK LLC253e5b98-c64f-3226-e063-6294a90a93522024-11-12WarningsExact identifier
application number: M004
TRIPLET ANTIBIOTICTRIPLET ANTIBIOTICALLIED TRADE LINK LLC26bd5ba4-264b-2a28-e063-6394a90ada802024-11-12WarningsExact identifier
application number: M004
basic care first aid antibiotic and burn reliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEAmazon.com Services LLC0df4c44d-6912-4db9-a703-a82da4c8ae762024-11-11WarningsExact identifier
application number: M004
SUPER SENSITIVE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTY7d4a5b21-82d2-4904-9577-4a9b2579076e2024-11-08WarningsExact identifier
application number: M004
dg health triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLDolgencorp, LLC4c97dada-966f-4de8-b5d9-e939cb456aea2024-11-06WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BA-S Medication Solutionsde07139e-ece9-424b-8468-f5ed4bbb2b2b2024-11-06WarningsExact identifier
application number: M004
good sense triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLL. Perrigo Companye9e913d8-8ec8-4465-ad3a-b524f6710a0f2024-11-06WarningsExact identifier
application number: M004
EUCALYPTUS EASE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTY09d77591-9472-4771-9090-3390bddf788a2024-11-06WarningsExact identifier
application number: M004
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATEA-S Medication Solutionse115d413-e41c-4e43-8184-493d64dfcd9f2024-11-06WarningsExact identifier
application number: M004
LEMON MYRTLE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTYf341b24c-9466-42f4-98fe-d1a1225919152024-11-06WarningsExact identifier
application number: M004
BacitracinBACITRACINA-S Medication Solutions00747e3a-389c-46bc-b6b9-9b3d1d98dbcf2024-11-06WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLSafeway46db4b66-85a2-47fc-a643-df6477e2ddff2024-11-06WarningsExact identifier
application number: M004
CALMING HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTYffcbe34d-3c53-47f9-9e4a-b5448afbbd5d2024-11-05WarningsExact identifier
application number: M004
Antibiotic, Pain and ScarBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLCVS Pharmacy8bb6cb64-103f-454a-95ad-c2c56b9cf71a2024-11-05WarningsExact identifier
application number: M004
BACITRACINBACITRACINMeijer Distribution Inc029e7150-1b9a-47c9-90bd-5f8bcd21365c2024-10-29WarningsExact identifier
application number: M004
SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEFPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEA-S Medication Solutions01131ba6-6d5b-4710-bec3-ba1769c08c792024-10-22WarningsExact identifier
application number: M004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55758-374-015575803740115 mL in 1 BOTTLE, PLASTIC15 mlHistorical
55758-374-025575803740230 mL in 1 BOTTLE, PLASTIC (55758-374-02) 30 ml2023-05-312027-08-01NoNoHistorical