OTC - ACTIVE INGREDIENT SECTION
Fexofenadine HCl USP 180 mg
Fexofenadine HCl USP 180 mg
anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregalatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, yellow iron oxide
temporarily relieves these symptoms due to hay fever or other respiratory allergies:
Do not use
Ask a doctor before use if you have
When using this product
Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding,
ask a health professional before use
Keep out of reach of children
Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children
Overdose Warning: Taking more than directed can cause serious health problems. Incase of overdose, get medical help or contact a Poison Control Center right away.
Antihistamine
Tamper Evident: Do not use if package is opened or if blister unite is torn broken or shows any signs of tampering.
| Class | Version | Type | Effective |
|---|---|---|---|
| FEXOFENADINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70692-134-29 | 2024-01-30 | C162847 | 48780-1 | 1030e365-32e4-111a-e063-dadaa90a10e2 | Fexofenadine HCl USP 180mg Allergy Relief - 24 hours |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70692-134-29 | Fexofenadine hydrochloride | 3 in 1 BLISTER PACK | TABLET | 3 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70692-134 | 70692-134-29 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POLYETHYLENE GLYCOL 6000 | 30IQX730WE | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| FEXOFENADINE HYDROCHLORIDE | 2S068B75ZU | ACTIB |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2019-10-18 | ||
| A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2019-10-18 |
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 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2019-10-18 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2019-10-18 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| b43fc254-c365-5e80-e053-2a95a90a799f | 9717c35e-cfd3-6605-e053-2995a90a1de5 | 2020-11-16 | Warnings | b43fc254-c365-5e80-e053-2a95a90a799f 9717c35e-cfd3-6605-e053-2995a90a1de5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.