good sense aller ease
- Product NDC
- 0113-0847
- 11-digit product format
- 001130847
- Labeler code
- 0113
- Product ID
- 0113-0847_5cd21fe5-5a25-4beb-a480-924996e65ee1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- fexofenadine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- L. Perrigo Company
- Application
- ANDA212971
- Marketing category
- ANDA
- Marketing start
- 2021-09-10
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 180 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212971-001 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | ||
| A212971-002 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 |
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 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 87673890dc5c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- good sense aller ease
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FEXOFENADINE HYDROCHLORIDE | 180 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2S068B75ZU | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 997420 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e533a008-b437-401e-ab50-bda31e6662d3 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 0113-0847-00 | good sense aller ease | 150 in 1 BOTTLE | TABLET, FILM COATED | 150 | 3 | |
| 0113-0847-22 | good sense aller ease | 15 in 1 CARTON | TABLET, FILM COATED | 15 | 3 | |
| 0113-0847-22 | good sense aller ease | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | 3 | |
| 0113-0847-39 | good sense aller ease | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 0113-0847-39 | good sense aller ease | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 3 | |
| 0113-0847-47 | good sense aller ease | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 0113-0847-95 | good sense aller ease | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 0113-0847-95 | good sense aller ease | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0113-0847-22 | EA - Each | 0113-0847 | 8e3e24c2-9975-4a06-aba2-3b626b10c935 | 1 | 2024-02-14 |
| 0113-0847-39 | EA - Each | 0113-0847 | 3ed7e6de-30ad-4d48-9c00-d143a2d4c422 | 1 | 2023-01-09 |
| 0113-0847-95 | EA - Each | 0113-0847 | 6cc1f1d1-b5e9-4773-815f-ab018ef2d568 | 1 | 2023-09-05 |
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 |
|---|---|---|---|---|
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | e533a008-b437-401e-ab50-bda31e6662d3 | 3 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | e533a008-b437-401e-ab50-bda31e6662d3 | 3 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | e533a008-b437-401e-ab50-bda31e6662d3 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0113-0847-00 | 00113084700 | 150 in 1 BOTTLE | Historical | |||||
| 0113-0847-22 | 00113084722 | 15 BLISTER PACK in 1 CARTON (0113-0847-22) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 15 blister pack | 2021-09-14 | 0000-00-00 | No | No | Current |
| 0113-0847-39 | 00113084739 | 1 BOTTLE in 1 CARTON (0113-0847-39) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-09-10 | 0000-00-00 | No | No | Current |
| 0113-0847-47 | 00113084747 | 1 BOTTLE in 1 CARTON (0113-0847-47) / 150 TABLET, FILM COATED in 1 BOTTLE (0113-0847-00) | 1 bottle | 2025-08-21 | No | No | Current | |
| 0113-0847-95 | 00113084795 | 1 BOTTLE in 1 CARTON (0113-0847-95) / 45 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-09-14 | 0000-00-00 | No | No | Current |