Indications and uses
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature)
Drug Facts
Loratadine, USP 10 mg
Antihistamine
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
| adults and children 6 years and over | 1 tablet daily; not more than 1 tablet in 24 hours |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
1-800-CLARITIN (1-800-252-7484) or
www.claritin.com
Dist by: Bayer HealthCare LLC
Whippany, NJ 07981
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 206805 | Claritin 24HR Allergy 10 MG Oral Tablet | PSN | 2 |
| 311372 | loratadine 10 MG 24HR Oral Tablet | PSN | 2 |
| 206805 | loratadine 10 MG Oral Tablet [Claritin] | SBD | 2 |
| 311372 | loratadine 10 MG Oral Tablet | SCD | 2 |
| 206805 | Claritin 10 MG 24 HR Oral Tablet | SY | 2 |
| 206805 | Claritin 10 MG Oral Tablet | SY | 2 |
| 311372 | loratadine 10 MG 24 HR Oral Tablet | SY | 2 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52904-630-03 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2b5c-111a-e063-dadaa90a10e2 | Claritin ® |
| 52904-630-20 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2b5c-111a-e063-dadaa90a10e2 | Claritin ® |
| 52904-630-25 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2b5c-111a-e063-dadaa90a10e2 | Claritin ® |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52904-630-03 | Claritin | 1 in 1 BLISTER PACK | TABLET | 1 | 2 | |
| 52904-630-03 | Claritin | 1 in 1 POUCH | TABLET | 1 | 2 | |
| 52904-630-20 | Claritin | 20 in 1 CARTON | TABLET | 20 | 2 | |
| 52904-630-20 | Claritin | 1 in 1 POUCH | TABLET | 1 | 2 | |
| 52904-630-25 | Claritin | 25 in 1 CARTON | TABLET | 25 | 2 | |
| 52904-630-25 | Claritin | 1 in 1 POUCH | TABLET | 1 | 2 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 11523-7160-1 | EA - Each | 11523-7160 | 855a386e-d048-4eb2-bd46-2879970928ae | 1 | 2013-02-13 |
| 11523-7160-2 | EA - Each | 11523-7160 | f16535e3-da09-49d8-a400-b4328a9b0ac1 | 1 | 2013-02-13 |
| 11523-7160-3 | EA - Each | 11523-7160 | 6bdfb32c-53ad-4c7d-85d1-51ff7fa065b7 | 1 | 2013-02-13 |
| 11523-7160-5 | EA - Each | 11523-7160 | a1906c20-1d1d-43af-93a8-9e8abdde3f0c | 1 | 2013-02-13 |
| 11523-7160-9 | EA - Each | 11523-7160 | daafcf57-7015-4018-af3f-c0d07661841f | 1 | 2024-05-16 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52904-630 | 52904-630-03, 52904-630-20, 52904-630-25 |
| 11523-7160 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| loratadine | 7AJO3BO7QN | ACTIB |
| lactose monohydrate | EWQ57Q8I5X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| magnesium stearate | 70097M6I30 | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019658-002 | CLARITIN | LORATADINE | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | |
| N019658-003 | CLARITIN HIVES RELIEF | LORATADINE | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 |
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 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Claritin | LORATADINE | Bayer HealthCare LLC. | 660ac9df-f1b1-4c89-94dd-9fae0a013f3c | 2025-12-05 | Warnings | 11523-7160 |
| c9fb571f-a54e-442b-adeb-9b6fbc75fea9 | 677bf76d-e75d-4212-b1f2-eaaf25b27cb7 | 2022-06-07 | Warnings | c9fb571f-a54e-442b-adeb-9b6fbc75fea9 677bf76d-e75d-4212-b1f2-eaaf25b27cb7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.