NDC 24338-080-25 - OTOVEL
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 24338-080
- Requested NDC
- 24338-080-25
- Package NDCs from labels
- 24338-080-25, 24338-080-14
- Manufacturer
- Arbor Pharmaceuticals | Laboratorios Salvat | The Ritedose Corporation
- Effective date
- 2019-09-12
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| OTOVEL - Arbor Pharmaceuticals | Laboratorios Salvat | The Ritedose Corporation | Arbor Pharmaceuticals | Laboratorios Salvat | The Ritedose Corporation | 2019-09-12 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 24338-080-14 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ec5a-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use OTOVEL safely and effectively. See full prescribing information for OTOVEL. OTOVEL (ciprofloxacin and fluocinolone acetonide) otic solution Initial U.S. Approval: 2016 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 24338-080-14 | OTOVEL | 14 in 1 POUCH | SOLUTION | 14 | 3 | |
| 24338-080-14 | OTOVEL | 1 in 1 CARTON | SOLUTION | 1 | 3 | |
| 24338-080-25 | OTOVEL | 0.25 mL in 1 VIAL, SINGLE-DOSE | SOLUTION | 0.25 | 3 |
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 |
|---|---|---|---|---|---|---|
| Virility Liquescence | AVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIA | Nutritional Specialties, Inc. | 81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f | 2023-03-29 | Warnings | PDC6A3C0OX |
| NOVOLOG | INSULIN ASPART | Novo Nordisk | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 2023-02-28 | Warnings, Adverse reactions | 059QF0KO0R |
| Fluocinolone Acetonide | FLUOCINOLONE ACETONIDE | Quagen Pharmaceuticals LLC | a625fe98-8630-4b27-b2fc-4b045847d8f1 | 2023-02-26 | Warnings, Adverse reactions | 0CD5FD6S2M |
| Fluocinolone Acetonide | FLUOCINOLONE ACETONIDE | Quagen Pharmaceuticals LLC | fa5eba5b-57bf-4d46-b0e1-c7104542cb46 | 2023-02-26 | Adverse reactions | 0CD5FD6S2M |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | Quagen Pharmaceuticals LLC | 2bcea813-d629-42c5-8953-fa231b4cbf58 | 2023-02-26 | Adverse reactions | 0CD5FD6S2M |
| Rehydrate | AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADEN | ParaDocs All Natural, Inc. | 648fab10-c46b-420f-a42c-6642009d83fb | 2023-01-10 | Warnings | 059QF0KO0R |
| Refresh Digital PF | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80 | Allergan, Inc. | 97e83e68-6374-4df4-93f6-d707fc32748d | 2022-11-28 | Warnings | PDC6A3C0OX 6OZP39ZG8H |
| Refresh Digital | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | b2bd34d4-fab9-4f4b-9be2-5d30b55f5b81 | 2022-11-28 | Warnings | PDC6A3C0OX 6OZP39ZG8H |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | Cosette Pharmaceuticals, Inc. | a6e77bc5-ddb3-491a-bf16-d6d253886bb0 | 2022-11-16 | Adverse reactions | 0CD5FD6S2M |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | b45e9f1d-9c48-4b46-8541-d846b89540df | 2022-10-26 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye wash | PURIFIED WATER | McKesson | bd089fde-24ba-4de5-e053-2995a90a39bb | 2022-10-18 | Warnings | 059QF0KO0R |
| Bach Original Flower Remedies Rock Water | WATER | Nelson Bach USA Limited | ea242559-1618-3354-e053-2a95a90a1a95 | 2022-10-03 | Warnings | 059QF0KO0R |
| REFRESH OPTIVE | CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN | Allergan, Inc. | 7f8d88af-fd3b-4138-af61-f24c59ccebd7 | 2022-09-23 | Warnings | PDC6A3C0OX |
| Sterile Water | WATER | Medical Purchasing Solutions, LLC | e90b47e3-9636-b9ee-e053-2a95a90ad48c | 2022-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| Ciprofloxacin | CIPROFLOXACIN | Sagent Pharmaceuticals | 7049f870-6741-4a67-8033-398c36126a06 | 2022-09-19 | Boxed warning, Warnings, Adverse reactions | 5E8K9I0O4U |
| REFRESH OPTIVE Advanced | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | ebd0839e-2e1d-4e0e-986c-19f1f5c76358 | 2022-09-15 | Warnings | PDC6A3C0OX 6OZP39ZG8H |
| REFRESH OPTIVE Advanced | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80 | Allergan, Inc. | aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0 | 2022-09-01 | Warnings | PDC6A3C0OX 6OZP39ZG8H |
| Glycerinum | GLYCERINUM | Hahnemann Laboratories, INC. | e34f8796-85b5-2946-e053-2995a90a251e | 2022-07-08 | PDC6A3C0OX | |
| REFRESH Optive Mega-3 | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80 | Allergan, Inc. | c5f2b3f2-2071-45bd-a010-67f848bc0233 | 2022-06-30 | Warnings | PDC6A3C0OX 6OZP39ZG8H |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.