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 |
|---|---|---|---|---|---|---|
| Hydrogen Peroxide | HYDROGEN PEROXIDE | JHK Inc | 1472c854-09c8-4ad8-b8a6-0235440ac26b | 2024-04-26 | Warnings | M004 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | JHK Inc | abae6a80-e859-47b5-8e34-d391eb854583 | 2024-04-26 | Warnings | M004 |
| Antiseptic | BENZALKONIUM CHLORIDE, BENZOCAINE | JHK Inc | 0ac5d890-c262-4a30-9fd8-2de6cb0f7601 | 2024-04-25 | Warnings | M004 |
| First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | M-star (Hubei) Health&Care Products Co., Ltd. | c6f2656e-b822-4d61-b557-dd2046dd51f5 | 2024-04-01 | Warnings | M004 |
| Antibiotic | BACITRACIN ZINC, POLYMYXIN B SULFATE | CVS PHARMACY, INC | 32e92acf-2e48-4933-8e08-e1df650e7d19 | 2024-03-15 | Warnings | M004 |
| Major Bacitracin | BACITRACIN | Major Pharmaceuticals | 13288efb-e282-68f8-e063-6294a90ae712 | 2024-03-08 | Warnings | M004 |
| UniShield TRIPLE ANTIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Unishield | 00b85d3a-322b-43c1-b022-5f6ed50c6609 | 2024-03-02 | Warnings | M004 |
| Triple Antibiotic Plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Chain Drug Marketing Association Inc. | 1277942d-753f-ab69-e063-6394a90a496a | 2024-02-28 | Warnings | M004 |
| Triple Antibiotic with Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE | Safetec of America, Inc. | ca1df4a0-844d-4b1d-b972-f2704a8ebbab | 2024-02-16 | Warnings | M004 |
| Single Antibiotic | BACITRACIN ZINC | Safetec of America, Inc. | 9993c204-6e61-4da3-90ef-2b7dfa09c920 | 2024-02-14 | Warnings | M004 |
| Single Antibiotic with Neomycin | NEOMYCIN SULFATE | Safetec of America | e989cf7e-f3d1-42d2-af45-fc80095b97cb | 2024-02-08 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Safetec of America, Inc. | 96c41fc1-81f9-4757-abc6-867b5383ed5d | 2024-02-07 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Safetec of America, Inc. | 2c2aa8af-2adb-4f59-ac20-15818d0e28e7 | 2024-02-07 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Safetec of America, Inc. | 03c05028-5a5f-4690-a836-cc1b1044ab39 | 2024-02-05 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Safetec of America, Inc. | 59494d5c-dd8a-431c-8e6a-4e1151ba7460 | 2024-02-05 | Warnings | M004 |
| Triple Antibiotic | FIRST AID ANTIBIOTIC | BluePoint Laboratories | c47e15bd-1062-4cca-e053-2995a90a9075 | 2024-01-31 | Warnings | M004 |
| Neomycin | NEOMYCIN OINTMENT | Dynarex Corporation | 0f9e087b-6e86-a3c7-e063-6394a90ac8d4 | 2024-01-23 | Warnings | M004 |
| Antibiotic and Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Target Corporation | 050be94c-1fbb-4d84-82c6-841aac8f318e | 2024-01-18 | Warnings | M004 |
| Leader Triple Antibiotic | FIRST AID TRIPLE ANTIBIOTIC | Cardinal Health 110,Inc. | 844cd9a1-b68e-47d8-a5eb-c9e880ba019e | 2024-01-18 | Warnings | M004 |
| Multi-Action Antibiotic and Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE OINTMENT | Target Corporation | 8fecff32-bd67-4351-90f7-0c28cb335ea3 | 2024-01-18 | 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 |