Allergy Relief
- Product NDC
- 76162-915
- 11-digit product format
- 761620915
- Labeler code
- 76162
- Product ID
- 76162-915_5c5224ad-696b-9fa8-e063-6394a90a7770
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Levocetirizine Dihydrochloride USP, 5 mg
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Topco Associates, LLC
- Application
- ANDA213513
- Marketing category
- ANDA
- Marketing start
- 2026-09-24
- Substance
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|---|---|---|---|---|---|
| Goodmeds Levocetirizine Dihydrochloride 5mg 365 count | LEVOCETIRIZINE DIHYDROCHLORIDE 5MG | Cabinet Health P.B.C. | 54f34304-952e-2f07-e063-6394a90a80ee | 2026-06-23 | Warnings | 213513 ANDA213513 |
| Levocetirizine Dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Farmacias De Similares TX LLC | 4ed17484-5609-d993-e063-6294a90a82a2 | 2026-04-06 | Warnings | 213513 ANDA213513 |
| Curist Allergy Relief | LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG | Little Pharma, Inc. | f2a2a5bc-2efa-c550-e053-2a95a90a55ff | 2026-03-05 | Warnings | 213513 ANDA213513 |
| Levocetirizine Dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Sportpharm LLC | 8c00c74f-4377-4f2c-943e-e55afa5a824f | 2026-02-14 | 213513 ANDA213513 | |
| Curist Allergy Relief | LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG | Little Pharma, Inc. | feabf140-e283-dcd5-e053-6394a90a2917 | 2025-04-16 | Warnings | 213513 ANDA213513 |
| Allery Relief 24HR | ALLERY RELIEF 24HR | Allegiant Health | c523c210-b1c4-4049-9c72-2b31c9c93137 | 2024-04-02 | Warnings | 213513 ANDA213513 |
| Levocetirizine Dihydrochloride | LEVOCETIRIZINE DIHYDROCHLORIDE | Camber Consumer Care Inc | be72dafb-62ae-40b2-874f-1d8920fad19d | 2020-11-30 | 213513 ANDA213513 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76162-915-35 | 76162091535 | 1 BOTTLE in 1 CARTON (76162-915-35) / 35 TABLET, COATED in 1 BOTTLE | 1 bottle | 2026-09-24 | No | No | Historical |
| 76162-915-80 | 76162091580 | 1 BOTTLE in 1 CARTON (76162-915-80) / 80 TABLET, COATED in 1 BOTTLE | 1 bottle | 2026-09-24 | No | No | Historical |