NDC 69238-2147-03 - Azelastine HCl
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
- 69238-2147
- Requested NDC
- 69238-2147-03
- Package NDCs from labels
- 69238-2147-3, 69238-2147-03
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Effective date
- 2025-11-03
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Azelastine HCl - Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals NY LLC | 2025-11-03 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69238-2147-3 | Azelastine HCl | 1 in 1 CARTON | SPRAY, METERED | 1 | 10 | |
| 69238-2147-3 | Azelastine HCl | 200 in 1 BOTTLE | SPRAY, METERED | 200 | 10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69238-2147 | AZELASTINE HCL (AZELASTINE) SPRAY, METERED [AMNEAL PHARMACEUTICALS NY LLC] | 9 | Current NDC, 2 package rows | 20240608_82610437-25f4-4ae0-9d6a-381e9932f87d.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59e742a6-61f9-59f7-e063-6394a90a8738 | 2026-08-25 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59e7dfb1-49b5-d2be-e063-6394a90a04d8 | 2026-08-25 | Warnings | F5UM2KM3W7 |
| Sterile Water | WATER | REMEDYREPACK INC. | 5dd5d148-6e23-41de-bff5-551b2aea9598 | 2026-08-24 | Warnings, Adverse reactions | 059QF0KO0R |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59d3c369-86aa-8ebd-e063-6394a90aa806 | 2026-08-24 | Warnings | F5UM2KM3W7 |
| Biopure Antibacterial Hand Wipe | ANTIBACTERIAL HAND WIPE | Fujian Yifa Healthcare Products Co., Ltd. | 59d7fc3c-3a93-153d-e063-6394a90ac647 | 2026-08-24 | Warnings | F5UM2KM3W7 |
| Claravie | BENZALKONIUM CHLORIDE | Gentell LLC | 59887af3-9b22-9664-e063-6294a90a57c6 | 2026-08-21 | Warnings | F5UM2KM3W7 |
| Family Beauty Antibacterial Hand Wipes | BENZALKONIUM CHLORIDE | Zhejiang Bright Care Co., Ltd. | 6ff604f7-4011-4f0e-aa2d-a46e1a973d13 | 2026-08-21 | Warnings | F5UM2KM3W7 |
| Softsoap Antibacterial Clean and Protect Cool Splash | BENZALKONIUM CHLORIDE | COLGATE PALMOLIVE COMPANY | 7d48e018-0874-4bbf-a95e-dc21702406c1 | 2026-08-20 | Warnings | F5UM2KM3W7 |
| Rohto All-In-One | HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE | The Mentholatum Company | 43e690e4-b381-46e3-838c-33aef5bdadde | 2026-08-20 | Warnings | 3NXW29V3WO |
| Olimpo Antibacterial | BENZALKONIUM CHLORIDE 0.1% | Industria La Popular, S.A. | 597e3b3e-51f0-5fcf-e063-6394a90ac297 | 2026-08-20 | Warnings | F5UM2KM3W7 |
| Benzalkonium Chloride | BENZALKONIUM CHLORIDE TOWELETTES | Trifecta Pharmaceuticals USA LLC | 59811e67-57f0-4db1-e063-6294a90a2ad8 | 2026-08-20 | Warnings | F5UM2KM3W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.