Claritin
- Product NDC
- 11523-7157
- 11-digit product format
- 115237157
- Labeler code
- 11523
- Product ID
- 11523-7157_4536fe84-5b46-ca4c-e063-6394a90ad03a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Bayer Healthcare LLC.
- Application
- NDA020704
- Marketing category
- NDA
- Marketing start
- 2002-11-27
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020704-002 | CLARITIN REDITABS | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | |
| N020704-003 | CLARITIN HIVES RELIEF REDITAB | LORATADINE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020704-002 | CLARITIN REDITABS | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2002-11-27 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020704-003 | CLARITIN HIVES RELIEF REDITAB | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2003-11-19 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Claritin
- Brand name suffix
- Reditabs
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LORATADINE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7AJO3BO7QN | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b681ea25-d00b-4c8a-8054-cc6f983ce337 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11523-7157-2 | ClaritinReditabs | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | 12 | |
| 11523-7157-2 | ClaritinReditabs | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 12 | |
| 11523-7157-3 | ClaritinReditabs | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 3 | 12 | |
| 11523-7157-3 | ClaritinReditabs | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 12 | |
| 11523-7157-4 | ClaritinReditabs | 2 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 2 | 12 | |
| 11523-7157-4 | ClaritinReditabs | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 12 | |
| 11523-7157-7 | ClaritinReditabs | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 12 | |
| 11523-7157-7 | ClaritinReditabs | 4 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 4 | 12 | |
| 11523-7157-8 | ClaritinReditabs | 5 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 5 | 12 | |
| 11523-7157-8 | ClaritinReditabs | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 12 | |
| 11523-7157-9 | ClaritinReditabs | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 12 | |
| 11523-7157-9 | ClaritinReditabs | 7 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 7 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 11523-7157-2 | EA - Each | 11523-7157 | 128f54a2-0776-4dea-a042-44b6442d3b69 | 1 | 2012-07-24 |
| 11523-7157-3 | EA - Each | 11523-7157 | fd89b497-47a4-4038-a766-17f963a2870b | 1 | 2012-07-24 |
| 11523-7157-8 | EA - Each | 11523-7157 | a461ab26-b1e4-4ea2-86d4-61841d1b15a0 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Loratadine | ACTIVE INGREDIENT | 7AJO3BO7QN | CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.] | 4 | |
| Loratadine | ACTIVE MOIETY | 7AJO3BO7QN | CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.] | 4 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.] | 4 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.] | 4 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.] | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11523-7157 | CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [BAYER HEALTHCARE LLC.] | 11 | Current NDC, Legacy NDC, 12 package rows | 20241208_b681ea25-d00b-4c8a-8054-cc6f983ce337.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 |
|---|---|---|---|---|---|---|
| Claritin Reditabs | LORATADINE | Bayer Healthcare LLC. | b681ea25-d00b-4c8a-8054-cc6f983ce337 | 2025-12-05 | Warnings | 020704 NDA020704 11523-7157 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 744830 | Claritin RediTabs 10 MG 24HR Disintegrating Oral Tablet | PSN | b681ea25-d00b-4c8a-8054-cc6f983ce337 | 12 |
| 311373 | loratadine 10 MG 24HR Disintegrating Oral Tablet | PSN | b681ea25-d00b-4c8a-8054-cc6f983ce337 | 12 |
| 744830 | loratadine 10 MG Disintegrating Oral Tablet [Claritin] | SBD | b681ea25-d00b-4c8a-8054-cc6f983ce337 | 12 |
| 311373 | loratadine 10 MG Disintegrating Oral Tablet | SCD | b681ea25-d00b-4c8a-8054-cc6f983ce337 | 12 |
| 744830 | Claritin 10 MG Disintegrating Oral Tablet | SY | b681ea25-d00b-4c8a-8054-cc6f983ce337 | 12 |
| 744830 | Claritin 24HR RediTabs 10 MG Disintegrating Oral Tablet | SY | b681ea25-d00b-4c8a-8054-cc6f983ce337 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11523-7157-2 | 11523715702 | 1 BLISTER PACK in 1 CARTON (11523-7157-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 1 blister pack | 2002-11-27 | 0000-00-00 | No | No | Current |
| 11523-7157-3 | 11523715703 | 3 BLISTER PACK in 1 CARTON (11523-7157-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 3 blister pack | 2002-11-27 | 0000-00-00 | No | No | Current |
| 11523-7157-4 | 11523715704 | 2 BLISTER PACK in 1 CARTON (11523-7157-4) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2 blister pack | 2002-11-27 | 0000-00-00 | No | No | Current |
| 11523-7157-7 | 11523715707 | 4 BLISTER PACK in 1 CARTON (11523-7157-7) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 4 blister pack | 2002-11-27 | 0000-00-00 | No | No | Current |
| 11523-7157-8 | 11523715708 | 5 BLISTER PACK in 1 CARTON (11523-7157-8) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 5 blister pack | 2002-11-27 | 0000-00-00 | No | No | Current |
| 11523-7157-9 | 11523715709 | 7 BLISTER PACK in 1 CARTON (11523-7157-9) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 7 blister pack | 2002-11-27 | 0000-00-00 | No | No | Current |