Fexofenadine Hydrochloride
- Product NDC
- 30142-091
- 11-digit product format
- 301420091
- Labeler code
- 30142
- Product ID
- 30142-091_31573c90-831d-5cae-0ff1-62ffa650de02
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride 60 mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Kroger Company
- Application
- ANDA076502
- Marketing category
- ANDA
- Marketing start
- 2022-01-03
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | 30142-091 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 30142-091 | 30142-091-12 | I | Inactivated by FDA | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076502-001 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2006-04-11 | ||
| A076502-002 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2006-04-11 | ||
| A076502-003 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2006-04-11 | ||
| A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-007 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-009 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2011-04-12 |
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 | A076502-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2006-04-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076502-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2006-04-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076502-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2006-04-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076502-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076502-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076502-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076502-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076502-009 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2011-04-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2006-04-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2006-04-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2006-04-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-009 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2011-04-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076502-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2006-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076502-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2006-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076502-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2006-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076502-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076502-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076502-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076502-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076502-009 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2011-04-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2006-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2006-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2006-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-009 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2011-04-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2006-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2006-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2006-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-12 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076502-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076502-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076502-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076502-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076502-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076502-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076502-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076502-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076502-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076502-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076502-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076502-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076502-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076502-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076502-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076502-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076502-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076502-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076502-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076502-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076502-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076502-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076502-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076502-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076502-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076502-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076502-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076502-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076502-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076502-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076502-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076502-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076502-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076502-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 30142-091-12 | Fexofenadine Hydrochloride | 2 in 1 CARTON | TABLET | 2 | 5 | |
| 30142-091-12 | Fexofenadine Hydrochloride | 6 in 1 BLISTER PACK | TABLET | 6 | 5 |
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 997501 | fexofenadine HCl 60 MG Oral Tablet | PSN | 98768939-d3d2-b294-4a20-57eba65880ab | 5 |
| 997501 | fexofenadine hydrochloride 60 MG Oral Tablet | SCD | 98768939-d3d2-b294-4a20-57eba65880ab | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 30142-091-12 | 30142009112 | 2 BLISTER PACK in 1 CARTON (30142-091-12) / 6 TABLET in 1 BLISTER PACK | 2 blister pack | 2022-01-03 | 0000-00-00 | No | No | Current |