Allegra Allergy
- Product NDC
- 41167-4124
- 11-digit product format
- 411674124
- Labeler code
- 41167
- Product ID
- 41167-4124_fb8ea8ca-b8a9-46af-9c21-d2df1100e9ff
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- fexofenadine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chattem, Inc.
- Application
- NDA020872
- Marketing category
- NDA
- Marketing start
- 2020-10-01
- 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
- 2027-12-31
- 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 package | package | 41167-4124 | 41167-4124-7 | D | Discontinued by firm | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020872-005 | CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | |
| N020872-006 | CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | RLD | 2011-01-24 | |
| N020872-007 | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | RLD | 2011-01-24 | |
| N020872-008 | ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | RLD | 2011-01-24 | |
| N020872-009 | ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | |
| N020872-010 | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 |
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 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020872-009 | ALLEGRA HIVES | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020872-010 | ALLEGRA ALLERGY | 180MG | TABLET / ORAL | RLD, RS | 2011-01-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020872-005 | CHILDREN'S ALLEGRA ALLERGY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2011-01-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020872-006 | CHILDREN'S ALLEGRA HIVES | 30MG | TABLET / ORAL | RLD | 2011-01-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020872-007 | ALLEGRA ALLERGY | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020872-008 | ALLEGRA HIVES | 60MG | TABLET / ORAL | RLD | 2011-01-24 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Allegra Allergy
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FEXOFENADINE HYDROCHLORIDE | 180 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2S068B75ZU | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 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 |
|---|---|---|---|---|---|---|
| 41167-4124-0 | Allegra Allergy | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 64 | |
| 41167-4124-0 | Allegra Allergy | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 64 | |
| 41167-4124-3 | Allegra Allergy | 2 in 1 PACKAGE | TABLET, FILM COATED | 2 | 64 | |
| 41167-4124-5 | Allegra Allergy | 55 in 1 BOTTLE | TABLET, FILM COATED | 55 | 64 | |
| 41167-4124-7 | Allegra Allergy | 84 in 1 BOTTLE | TABLET, FILM COATED | 84 | 64 | |
| 41167-4124-7 | Allegra Allergy | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 64 | |
| 41167-4124-8 | Allegra Allergy | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 64 | |
| 41167-4124-8 | Allegra Allergy | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 64 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 41167-4124-0 | EA - Each | 41167-4124 | d0d30baa-eca0-4e55-860a-4f0cc7069c9a | 1 | 2022-09-12 |
| 41167-4124-3 | EA - Each | 41167-4124 | 8cb7279c-fe40-4a52-85a4-50def71f52ce | 1 | 2023-03-13 |
| 41167-4124-7 | EA - Each | 41167-4124 | 5cd50192-8f0e-404f-99cd-bd64b88033a2 | 1 | 2022-09-12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41167-4124 | ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [CHATTEM, INC.] | 62 | Current NDC, Legacy NDC, 8 package rows | 20241116_81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173.zip |
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 |
|---|---|---|---|---|---|---|
| Allegra Allergy, Travel BASIX | FEXOFENADINE HYDROCHLORIDE | Lil' Drug Store Products, Inc | b82d993a-16ff-4037-a182-7010de8e1cdd | 2026-04-27 | Warnings | 020872 NDA020872 |
| Allegra Allergy | FEXOFENADINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | e8a00fa1-79af-4ce6-885f-0ce12c5da836 | 2026-04-22 | Warnings | 020872 NDA020872 |
| Allegra Allergy | FEXOFENADINE HYDROCHLORIDE | Chattem, Inc. | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 2026-04-14 | Warnings | 020872 NDA020872 41167-4124 |
| Allegra Hives 24hr | FEXOFENADINE HYDROCHLORIDE | Chattem, Inc. | 490b4c5f-448b-4563-928b-837117b59b9f | 2026-01-12 | Warnings | 020872 NDA020872 |
| Allegra Allergy | FEXOFENADINE HYDROCHLORIDE | Chattem, Inc. | f061d6b1-89f7-4d5f-ac59-9c73408517c1 | 2025-02-19 | Warnings | 020872 NDA020872 |
| ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | A-S Medication Solutions | b5ce28f8-f6c3-4113-9317-e1c98e5030ef | 2024-07-30 | Warnings | 020872 NDA020872 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 997422 | Allegra 180 MG Oral Tablet | PSN | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 64 |
| 997502 | Allegra Allergy 60 MG Oral Tablet | PSN | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 64 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 64 |
| 997501 | fexofenadine HCl 60 MG Oral Tablet | PSN | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 64 |
| 997422 | fexofenadine hydrochloride 180 MG Oral Tablet [Allegra] | SBD | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 64 |
| 997502 | fexofenadine hydrochloride 60 MG Oral Tablet [Allegra] | SBD | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 64 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 64 |
| 997501 | fexofenadine hydrochloride 60 MG Oral Tablet | SCD | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 64 |
| 997422 | Allegra 180 MG Oral Tablet | SY | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 64 |
| 997502 | Allegra 60 MG Oral Tablet | SY | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 64 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173 | 64 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41167-4124-0 | 41167412400 | 1 BOTTLE in 1 CARTON (41167-4124-0) / 90 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2020-12-01 | 0000-00-00 | No | No | Current |
| 41167-4124-3 | 41167412403 | 2 BOTTLE in 1 PACKAGE (41167-4124-3) / 55 TABLET, FILM COATED in 1 BOTTLE (41167-4124-5) | 2 bottle | 2020-10-01 | 0000-00-00 | No | No | Current |
| 41167-4124-5 | 41167412405 | 55 in 1 BOTTLE | Historical | |||||
| 41167-4124-7 | 41167412407 | 1 BOTTLE in 1 CARTON (41167-4124-7) > 84 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-02-01 | 0000-00-00 | No | No | Current |
| 41167-4124-8 | 41167412408 | 1 BOTTLE in 1 CARTON (41167-4124-8) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2022-05-01 | 0000-00-00 | No | No | Current |