Claritin
- Product NDC
- 70518-2951
- Requested package NDC
- 70518-2951-0
- 11-digit product format
- 705182951
- Labeler code
- 70518
- Product ID
- 70518-2951_d79be82a-1bed-d2b0-e053-2995a90ab00f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA019658
- Marketing category
- NDA
- Marketing start
- 2020-12-01
- Marketing end
- 0000-00-00
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70518-2951 | 70518-2951-0 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| 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 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 | 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… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019658-002 | CLARITIN | 10MG | TABLET / ORAL | RLD, RS | 2002-11-27 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019658-003 | CLARITIN HIVES RELIEF | 10MG | TABLET / ORAL | RLD, RS | 2003-11-19 | 782e0a99824c… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70518-2951-0 | 2022-02-09 | C162847 | 48780-1 | d6a99b3a-0048-a426-e053-dadaa90af4c2 | Non-Drowsy*Claritin ® loratadine tablets 10 mg/antihistamine |
| 70518-2951-0 | 2022-01-28 | C162847 | 48780-1 | d6a99b3a-0048-a426-e053-dadaa90af4c2 | Non-Drowsy*Claritin ® loratadine tablets 10 mg/antihistamine |
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 | LORATADINE | Bayer HealthCare LLC. | 660ac9df-f1b1-4c89-94dd-9fae0a013f3c | 2025-12-05 | Warnings | 019658 NDA019658 |
| Claritin | LORATADINE | Bayer HealthCare LLC | ac32d6f9-f553-4d5c-ad36-575af5ea56de | 2025-12-04 | Warnings | 019658 NDA019658 |
| Claritin | LORATADINE | R J General Corporation | a34e8cb7-4fdf-45be-b288-45d93eef6220 | 2025-11-17 | Warnings | 019658 NDA019658 |
| Claritin, BSX Non-Drowsy, 24 Hour | LORATADINE | Lil' Drug Store Products, Inc | f85b0527-107c-4a4a-aad7-61d2f52bad63 | 2023-03-17 | Warnings | 019658 NDA019658 |
| Claritin | LORATADINE | Navajo Manufacturing Company | 60a5dc14-3f74-8414-e053-2991aa0ad34a | 2023-03-01 | Warnings | 019658 NDA019658 |
| Claritin | LORATADINE | Navajo Manufacturing Company Inc. | 219ab9c4-d0c4-4256-ab64-66d0260886bd | 2023-03-01 | Warnings | 019658 NDA019658 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-2951-0 | 70518295100 | 1 BLISTER PACK in 1 CARTON (70518-2951-0) > 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2020-12-01 | 0000-00-00 | No | No | Current |