allergy relief
- Product NDC
- 37808-847
- 11-digit product format
- 378080847
- Labeler code
- 37808
- Product ID
- 37808-847_5857482f-bc9f-472a-b86b-ec2e2b83f6dc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- fexofenadine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- H E B
- Application
- ANDA212971
- Marketing category
- ANDA
- Marketing start
- 2021-12-22
- Marketing end
- 0000-00-00
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 180 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 37808-847 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 37808-847 | 37808-847-22 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 37808-847 | 37808-847-39 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 37808-847 | 37808-847-49 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 37808-847 | 37808-847-95 | D | Discontinued by firm | 2026-10-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | caaa826d4ba7… | ||
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37808-847-22 | allergy relief | 15 in 1 CARTON | TABLET, FILM COATED | 15 | 2 | |
| 37808-847-22 | allergy relief | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | 2 | |
| 37808-847-39 | allergy relief | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 37808-847-39 | allergy relief | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 2 | |
| 37808-847-49 | allergy relief | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | 2 | |
| 37808-847-49 | allergy relief | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 37808-847-95 | allergy relief | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 37808-847-95 | allergy relief | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | 2 |
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 | Proficient Rx LP | 4a9b4b7f-0441-44d3-86c7-2542ef4b119a | 2022-12-01 | Warnings | 212971 ANDA212971 |
| Fexofenadine Hydrochloride | FEXOFENADINE HYDROCHLORIDE | Padagis Israel Pharmaceuticals Ltd | e43b561e-d68a-47af-be93-d710f0f77505 | 2022-02-22 | Warnings | 212971 ANDA212971 |
| allergy relief | FEXOFENADINE HYDROCHLORIDE | Publix Super Markets Inc | 76014f1e-fa48-4d64-9ce6-1eaebd0419fc | 2022-01-21 | Warnings | 212971 ANDA212971 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 1930968f-6dac-463d-ab01-f5334d75cb28 | 2 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 1930968f-6dac-463d-ab01-f5334d75cb28 | 2 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 1930968f-6dac-463d-ab01-f5334d75cb28 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37808-847-22 | 37808084722 | 15 BLISTER PACK in 1 CARTON (37808-847-22) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 15 blister pack | 2021-12-22 | 0000-00-00 | No | No | Current |
| 37808-847-39 | 37808084739 | 1 BOTTLE in 1 CARTON (37808-847-39) > 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-12-22 | 0000-00-00 | No | No | Current |
| 37808-847-49 | 37808084749 | 1 BOTTLE in 1 CARTON (37808-847-49) > 40 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-12-30 | 0000-00-00 | No | No | Current |
| 37808-847-95 | 37808084795 | 1 BOTTLE in 1 CARTON (37808-847-95) > 45 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-12-22 | 0000-00-00 | No | No | Current |