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.
| 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.
| 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 |
|---|---|
| ALCOHOL | .48 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3K9958V90M | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fd7a227b-536c-b3f7-e053-6394a90a4158 | Available on FDA.report |
DailyMed Product Concepts#
| 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 | 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Honestly Battleborn First Aid for Real Man | TETRACYCLINE HYDROCHLORIDE | HONESTLY LLC | 13c1f2df-ba52-45e0-8868-a7518e9cdb55 | 2025-04-07 | Warnings | M004 |
| Honestly Battleborn First Aid for Real Man | TETRACYCLINE HYDROCHLORIDE | HONESTLY LLC | 93a6e02e-9f4b-4821-afa2-2029769f3088 | 2025-04-07 | Warnings | M004 |
| burn gel 01 | MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3227bdc9-9323-68eb-e063-6294a90a29d2 | 2025-04-06 | Warnings | M004 |
| Vitastem ULTRA | BACITRACIN ZINC | ViaDerma Distribution, Inc | fd96cc09-8522-44a5-b034-0d30e532410d | 2025-04-03 | Warnings | M004 |
| Vitastem Ultra First Aid Antibiotic | BACITRACIN ZINC | Viaderma Distribution Inc | e6986bf9-22ea-4484-a709-27bc91c9058d | 2025-03-18 | Warnings | M004 |
| Redicare Triple Antibiotic First Aid | TRIPLE ANTIBIOTIC FIRST AID OINTMENT | Redicare LLC | 9468979d-446e-e4be-e053-2995a90a3f21 | 2025-03-05 | Warnings | M004 |
| Neosporin Original | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Kenvue Brands LLC | 0ad21575-0e2d-24c2-e063-6394a90a616e | 2025-02-21 | Warnings | M004 |
| The Life Safety Pro Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Nantong Health & Beyond Hygienic Products Inc. | 64a7331f-98a6-4052-85b9-695c83b3bd16 | 2025-02-19 | Warnings | M004 |
| Vitastem | TETRACYCLINE HYDROCHLORIDE | ViaDerma Distribution, Inc. | a6630858-7038-425f-8a75-bb25f36a0dbe | 2025-02-18 | Warnings | M004 |
| Sheffield Triple Antibiotic | BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE | Sheffield Pharmaceuticals LLC | 1aa95046-c1f7-4fc7-acac-839065d998f6 | 2025-02-17 | Warnings | M004 |
| Equate | BACITRACIN ZINC ANTIBIOTIC OINTMENT | Walmart Inc. | 20908780-8803-4e19-e063-6394a90aab87 | 2025-02-01 | Warnings | M004 |
| Tetracyte Topical Tetracycline Hydrochloride | TETRACYCLINE HYDROCHLORIDE | VIADERMA DISTRIBUTION INC | 0961b097-ba41-40c2-aaec-dd291841bf09 | 2025-01-30 | Warnings | M004 |
| Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Welly Health PBC | 9446375d-4bb4-4bb1-bdc2-c18e995bfe26 | 2025-01-29 | Warnings | M004 |
| FAK Care4 Bus and School Yellow ORM D | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL | GFA Production (Xiamen) Co., Ltd. | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 2025-01-22 | Warnings | M004 |
| Members Mark Alcohol Prep Pads, Sterile | ISOPROPYL ALCOHOL | Sam's Club West Inc. | 13001877-ae90-40be-899d-fb38f3a38b12 | 2025-01-22 | Warnings | M004 |
| Equate Antibiotic Plus Pain, Itch, Scar Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | WalMart | 2b743271-4f58-4ba1-a04c-560f7f8a547e | 2025-01-16 | Warnings | M004 |
| Equate Antibiotic Plus Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | WalMart | e08b427f-d070-4521-ad3c-faf295531791 | 2025-01-16 | Warnings | M004 |
| NATUREPLEX ANTIBIOTIC | BACITRACIN ZINC AND POLYMYXIN B SULFATE | Natureplex LLC | 86ea3452-c810-4c9a-9f52-bcb0688020f9 | 2025-01-15 | Warnings | M004 |
| Balma Septic Antiseptic Hand Wash | BENZALKONIUM CHLORIDE | Rochester Midland Corporation | 1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528 | 2025-01-10 | Warnings | M004 |
| LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380 | CHLOROXYLENOL | ABC Compounding Co., Inc. | efa3938f-64de-77ba-e053-2a95a90ac840 | 2025-01-10 | Warnings | M004 |
Packages#
| 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 |