Allergy Relief
- Product NDC
- 49035-764
- 11-digit product format
- 490350764
- Labeler code
- 49035
- Product ID
- 49035-764_ea789002-cf01-443f-bd09-d478ec41a40c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCl
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- EQUATE (Wal-Mart Stores, Inc.)
- Application
- ANDA204507
- Marketing category
- ANDA
- Marketing start
- 2018-12-31
- Marketing end
- 0000-00-00
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 180 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 product | product | 49035-764 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 49035-764 | 49035-764-12 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 49035-764 | 49035-764-15 | D | Discontinued by firm | 2026-10-05 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2015-09-16 |
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 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49035-764-12 | EA - Each | 49035-764 | 06c2bbef-4707-42f1-8e74-b04d99404d36 | 1 | 2024-08-12 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Fexofenadine Hydrochloride | FEXOFENADINE HYDROCHLORIDE | SPIRIT PHARMACEUTICALS LLC | ae0f16f6-d07a-47e1-adb8-07803c6cfb13 | 2024-12-13 | Warnings | 204507 ANDA204507 |
| Curist Allergy Relief | FEXOFENADINE HYDROCHLORIDE 180 MG | Little Pharma, Inc. | f8228938-b5e3-0fa8-e053-6294a90a1d7c | 2024-11-15 | Warnings | 204507 ANDA204507 |
| Fexofenadine HCl | FEXOFENADINE HCL | Advanced Rx LLC | c067b335-79c5-4176-a0b3-bae02a0c23f8 | 2024-09-10 | Warnings | 204507 ANDA204507 |
| Fexofenadine HCL | FEXOFENADINE HCL | Akron Pharma Inc. | 08023b99-0634-4ac9-afd6-4f2d2e0d2c8a | 2024-08-20 | Warnings | 204507 ANDA204507 |
| Allergy Relief | FEXOFENADINE HYDROCHLORIDE | Magno-Humphries, Inc. | 1f8a2f98-7eba-48df-9589-58587d67ae0e | 2024-01-03 | Warnings | 204507 ANDA204507 |
| Fexofenadine HCl | FEXOFENADINE HCL | Camber Consumer Care | 1bb1bea3-b17d-4326-b037-7468add0df80 | 2023-11-06 | Warnings | 204507 ANDA204507 |
| Allergy Relief | FEXOFENADINE HCL | Allegiant Health | 61eebc8a-8d1e-48a2-afb1-eda9cb00ff97 | 2020-07-27 | Warnings | 204507 ANDA204507 |
| Fexofenadine HCl | FEXOFENADINE HCL | Proficient Rx LP | 3b147968-c6a8-4725-89b6-2eb443900e8f | 2019-11-01 | Warnings | 204507 ANDA204507 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49035-764-12 | 49035076412 | 1 BOTTLE, PLASTIC in 1 BOX (49035-764-12) > 120 TABLET, COATED in 1 BOTTLE, PLASTIC | 2018-12-31 | 0000-00-00 | No | No | Current | |
| 49035-764-15 | 49035076415 | 15 BLISTER PACK in 1 CARTON (49035-764-15) > 1 TABLET, COATED in 1 BLISTER PACK | 15 blister pack | 2018-12-31 | 0000-00-00 | No | No | Current |