NDC 63629-8716-01 - Ofloxacin Otic
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
- 63629-8716
- Requested NDC
- 63629-8716-01
- Package NDCs from labels
- 63629-8716-1, 63629-8716-01
- Manufacturer
- Bryant Ranch Prepack
- Effective date
- 2024-09-19
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Ofloxacin Otic - Bryant Ranch Prepack | Bryant Ranch Prepack | 2024-09-19 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-8716-1 | Ofloxacin Otic | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | 106 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-8716 | OFLOXACIN OTIC (OFLOXACIN) SOLUTION [BRYANT RANCH PREPACK] | 106 | Current NDC, Legacy NDC, 1 package rows | 20240921_567fa672-5fd0-4a1d-bc12-054a9ac16117.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-8716-1 | ML - Milliliter | 63629-8716 | 450de0a2-d976-483b-ac2b-a80bb768feda | 1 | 2021-10-08 |
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 |
|---|---|---|---|---|---|---|
| Orajel 4X Medicated Toothache and Gum PM Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1cdaf4-3388-280c-e063-6294a90ac70f | 2026-08-31 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a28101f-ea8e-6071-e063-6294a90aad91 | 2026-08-31 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a3e62ce-52dc-121b-e063-6294a90a898f | 2026-08-31 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a49db18-c270-6f46-e063-6294a90afb5d | 2026-08-31 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a4ac18e-8ba5-bef6-e063-6394a90a8811 | 2026-08-31 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 5a4d11fa-3f65-b41f-e063-6394a90a30ae | 2026-08-31 | Warnings | F5UM2KM3W7 |
| Nacl 0.9% Normal Saline Solution | SODIUM CHLORIDE | CHI FUNG TECHNOLOGY COMPANY | 5a53c4c8-c9de-700c-e063-6394a90a3ab5 | 2026-08-31 | Warnings | 451W47IQ8X |
| BMNP Nat Mur | NATRUM MURIATICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5a57ccfd-ab6f-cb2c-e063-6394a90ae9e6 | 2026-08-31 | Warnings | 451W47IQ8X |
| Ofloxacin Otic | OFLOXACIN | REMEDYREPACK INC. | 42366170-e536-46a1-9735-d76e5820a9de | 2026-08-31 | Warnings, Adverse reactions | ANDA076527 242446 A4P49JAZ9H |
| Orajel 4X Medicated Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1b4133-0eac-2f8f-e063-6394a90af8f6 | 2026-08-28 | Warnings | F5UM2KM3W7 |
| Allergy Care | ADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR | NaturalCare | f3ca7f5a-1448-4670-ac02-b47ffb6c5585 | 2026-08-27 | Warnings | 451W47IQ8X |
| ofloxacin | OFLOXACIN OTIC | REMEDYREPACK INC. | 50bca624-4dc0-4d1b-a693-2eb602eaf2f2 | 2026-08-27 | Warnings, Adverse reactions | 242446 A4P49JAZ9H |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59ed87d5-dab1-abab-e063-6394a90a024d | 2026-08-26 | Warnings | F5UM2KM3W7 |
| KUGIG ALOE FOAMING INTIMATE WASH | INTIMATE CLEANSING FOAM | Hong Kong KangXing Centennial Management Limited | 59f4d398-1186-a168-e063-6294a90ab44b | 2026-08-26 | Warnings | 059QF0KO0R |
| ofloxacin | OFLOXACIN OTIC | REMEDYREPACK INC. | fe619d50-49bf-4fcc-9428-6108c45580eb | 2026-08-26 | Warnings, Adverse reactions | 242446 A4P49JAZ9H |
| Mercurochrome | BENZALKONIUM CHLORIDE | Vitamex USA, Corp | 21652b11-715d-0c54-e063-6294a90a8855 | 2026-08-26 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59fa27b4-dfd4-720b-e063-6394a90af659 | 2026-08-26 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59fb22d6-f6a4-42cd-e063-6394a90a859a | 2026-08-26 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59fbb054-461e-aa6e-e063-6394a90a470c | 2026-08-26 | Warnings | F5UM2KM3W7 |
| Saline | SALINE NASAL SPRAY | Dynarex Corporation | 3247ae7d-554f-baab-e063-6294a90aa3ec | 2026-08-25 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.