Alavert
- Product NDC
- 80070-100
- Requested package NDC
- 80070-100-24
- 11-digit product format
- 800700100
- Labeler code
- 80070
- Product ID
- 80070-100_b349557d-e1ba-435d-b0db-1cdce853b418
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LORATADINE and PSEUDOEPHEDRINE SULFATE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Foundation Consumer Brands
- Application
- ANDA076050
- Marketing category
- ANDA
- Marketing start
- 2021-12-15
- Substance
- LORATADINE; PSEUDOEPHEDRINE SULFATE
- Active strength
- 5; 120 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- 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 |
|---|---|---|---|---|---|---|---|
| A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 |
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 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alavert
- Brand name suffix
- Allergy and Congestion D-12 hour
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LORATADINE | 5 mg/1 |
| PSEUDOEPHEDRINE SULFATE | 120 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7AJO3BO7QN | Internal UNII lookup |
| Y9DL7QPE6B | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1a669f3c-36a6-439e-843d-47638fa217e8 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80070-100-12 | Alavert Allergy and Congestion D-12 hour | 2 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 2 | 2 | |
| 80070-100-12 | Alavert Allergy and Congestion D-12 hour | 6 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 6 | 2 | |
| 80070-100-24 | Alavert Allergy and Congestion D-12 hour | 4 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 4 | 2 | |
| 80070-100-24 | Alavert Allergy and Congestion D-12 hour | 6 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 6 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80070-100 | ALAVERT ALLERGY AND CONGESTION D-12 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [FOUNDATION CONSUMER BRANDS] | 2 | Current NDC, Legacy NDC, 4 package rows | 20211215_1a669f3c-36a6-439e-843d-47638fa217e8.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 |
|---|---|---|---|---|---|---|
| allergy and nasal congestion | LORATADINE, PSEUDOEPHEDRINE SULFATE | Kroger Company | 934dda74-7995-46f1-b6f2-f4b928a2eeb2 | 2026-07-08 | Warnings | 076050 ANDA076050 |
| allergy relief d 12 | LORATADINE, PSEUDOEPHEDRINE SULFATE | Walgreen Company | 7e6ea563-cc79-4683-b600-0691e0fb78ab | 2026-04-09 | Warnings | 076050 ANDA076050 |
| allergy relief d 12 | LORATADINE, PSEUDOEPHEDRINE SULFATE | CVS Pharmacy | 0ca2b074-7137-478c-b32c-67f834f6c454 | 2026-03-15 | Warnings | 076050 ANDA076050 |
| loratadine D | LORATADINE, PSEUDOEPHEDRINE SULFATE | Sportpharm LLC | bb54f613-b2ab-48fd-83c9-2038ec7097f6 | 2026-02-06 | Warnings | 076050 ANDA076050 |
| good neighbor pharmacy loratadine d | LORATADINE, PSEUDOEPHEDRINE SULFATE | Amerisource Bergen | 90b0a155-b92c-45e3-959f-8f21065d31dd | 2025-09-12 | Warnings | 076050 ANDA076050 |
| equate allergy and congestion relief | LORATADINE, PSEUDOEPHEDRINE SULFATE | Wal-Mart Stores Inc | 306e8736-b27f-4445-b613-3e5b609f8d42 | 2025-07-17 | Warnings | 076050 ANDA076050 |
| foster and thrive allergy D 12 hour | LORATADINE, PSEUDOEPHEDRINE SULFATE | Strategic Sourcing Services LLC | 4626e3ca-d3e9-46ad-9c53-66d27c82aed7 | 2025-06-13 | Warnings | 076050 ANDA076050 |
| allergy relief d | LORATADINE, PSEUDOEPHEDRINE SULFATE | Meijer Distribution Inc | dd19215c-0da7-483a-88e3-6a32ac210c4c | 2025-05-28 | Warnings | 076050 ANDA076050 |
| loratadine D | LORATADINE, PSEUDOEPHEDRINE SULFATE | Padagis Israel Pharmaceuticals Ltd | 01e61c73-3b81-4683-b1a9-8784c0d565b1 | 2025-03-03 | Warnings | 076050 ANDA076050 |
| Allergy and Congestion Relief | LORATADINE, PSEUDOEPHEDRINE SULFATE | L. Perrigo Company | b5589371-48bc-44a5-bcab-018a92e22796 | 2024-02-26 | Warnings | 076050 ANDA076050 |
| Allergy Relief D | LORATADINE, PSEUDOEPHEDRINE SULFATE | Rite Aid Corporation | f08ebf00-a1d7-4a6f-a84f-195d000de53d | 2024-02-16 | Warnings | 076050 ANDA076050 |
| kirkland signature allerclear d 12 hr | LORATADINE, PSEUDOEPHEDRINE SULFATE | Costco Wholesale Company | 1534720b-f8f8-4db5-99e0-cfa49acf9299 | 2023-07-07 | Warnings | 076050 ANDA076050 |
| topcare allergy and congestion relief | LORATADINE, PSEUDOEPHEDRINE SULFATE | Topco Associates LLC | dd93d172-2a3a-4e4c-a237-7668acbd537d | 2022-02-16 | Warnings | 076050 ANDA076050 |
| Alavert Allergy and Congestion D-12 hour | LORATADINE AND PSEUDOEPHEDRINE SULFATE | Foundation Consumer Brands | 1a669f3c-36a6-439e-843d-47638fa217e8 | 2021-12-07 | Warnings | 076050 ANDA076050 80070-100-24 80070-100 80070010024 |
| perrigo allergy d | LORATADINE, PSEUDOEPHEDRINE SULFATE | L. Perrigo Company | 955c9f49-38af-4b48-b325-60fa94bfe60b | 2021-10-08 | Warnings | 076050 ANDA076050 |
| Leader Allergy Relief D12 | LORATADINE, PSEUDOEPHEDRINE SULFATE | Cardinal Health 110, LLC. dba Leader | 98bd6186-2bd2-4f46-99df-f509bb00e03a | 2021-06-17 | Warnings | 076050 ANDA076050 |
| signature care allergy and congestion relief | LORATADINE, PSEUDOEPHEDRINE SULFATE | Safeway | e1993d05-248e-48da-838c-068f8263c2eb | 2021-03-08 | Warnings | 076050 ANDA076050 |
| allergy relief d | LORATADINE, PSEUDOEPHEDRINE SULFATE | Publix Super Markets Inc | 8209d7d5-4ecc-4170-ba50-5917bd8c46d4 | 2020-10-19 | Warnings | 076050 ANDA076050 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1242401 | Alavert D 5 MG / 120 MG 12HR Extended Release Oral Tablet | PSN | 1a669f3c-36a6-439e-843d-47638fa217e8 | 2 |
| 1242399 | pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral Tablet | PSN | 1a669f3c-36a6-439e-843d-47638fa217e8 | 2 |
| 1242401 | 12 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet [Alavert D] | SBD | 1a669f3c-36a6-439e-843d-47638fa217e8 | 2 |
| 1242399 | 12 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet | SCD | 1a669f3c-36a6-439e-843d-47638fa217e8 | 2 |
| 1242401 | Alavert D (loratadine 5 MG / pseudoephedrine sulfate 120 MG) 12 HR Extended Release Oral Tablet | SY | 1a669f3c-36a6-439e-843d-47638fa217e8 | 2 |
| 1242399 | loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral Tablet | SY | 1a669f3c-36a6-439e-843d-47638fa217e8 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 80070-100-24 | 80070010024 | 4 BLISTER PACK in 1 CARTON (80070-100-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 4 blister pack | 2021-12-15 | 0000-00-00 | No | No | Current |