Allegra-D Allergy and Congestion
- Product NDC
- 41167-4320
- Requested package NDC
- 41167-4320-7
- 11-digit product format
- 411674320
- Labeler code
- 41167
- Product ID
- 41167-4320_de126d31-d1bb-490f-bf3f-fd9faf4f20ab
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- fexofenadine hydrochloride and pseudoephedrine hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Chattem, Inc.
- Application
- NDA021704
- Marketing category
- NDA
- Marketing start
- 2011-03-03
- Substance
- FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 180; 240 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 180MG;240MG | TABLET, EXTENDED RELEASE / 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021704-002 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | 180MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-01-24 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021704-002 | 6613357 | 2020-12-25 | U-1159 | Drug product | 2011-07-01 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N021704-002 | 6613357 | 2020-12-25 | U-1159 | Drug product | 2011-07-01 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021704-002 | 6613357 | 2020-12-25 | U-1159 | Drug product | 2011-07-01 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021704-002 | 6613357 | 2020-12-25 | U-1159 | Drug product | 2011-07-01 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021704-002 | 6613357 | 2020-12-25 | U-1159 | Drug product | 2011-07-01 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021704-002 | 6613357 | 2020-12-25 | U-1159 | Drug product | 2011-07-01 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Allegra-D Allergy and Congestion
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FEXOFENADINE HYDROCHLORIDE | 180 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 240 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2S068B75ZU | Internal UNII lookup |
| 6V9V2RYJ8N | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41167-4320-3 | Allegra-D Allergy and Congestion | 5 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 5 | 33 | |
| 41167-4320-3 | Allegra-D Allergy and Congestion | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | 33 | |
| 41167-4320-5 | Allegra-D Allergy and Congestion | 2 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 2 | 33 | |
| 41167-4320-5 | Allegra-D Allergy and Congestion | 5 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 5 | 33 | |
| 41167-4320-7 | Allegra-D Allergy and Congestion | 3 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 3 | 33 | |
| 41167-4320-7 | Allegra-D Allergy and Congestion | 5 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 5 | 33 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 41167-4320-3 | EA - Each | 41167-4320 | 8821ac71-43a9-40df-af54-7508f3a41a45 | 1 | 2012-07-24 |
| 41167-4320-5 | EA - Each | 41167-4320 | 2beb9aee-f276-48ad-a073-9fd0b7dfa406 | 1 | 2012-07-24 |
| 41167-4320-7 | EA - Each | 41167-4320 | 15273949-82a5-4616-8364-207c7d24b0ad | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41167-4320 | ALLEGRA-D ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.] | 32 | Current NDC, Legacy NDC, 6 package rows | 20201201_1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403.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-D Allergy and Congestion | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | Chattem, Inc. | 1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403 | 2026-01-12 | Warnings | 021704 NDA021704 41167-4320-7 41167-4320 41167432007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 997515 | Allegra-D 180 MG / 240 MG 24HR Extended Release Oral Tablet | PSN | 1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403 | 33 |
| 997415 | fexofenadine HCl 180 MG / pseudoephedrine HCl 240 MG 24HR Extended Release Oral Tablet | PSN | 1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403 | 33 |
| 997515 | 24 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral Tablet [Allegra-D] | SBD | 1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403 | 33 |
| 997415 | 24 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral Tablet | SCD | 1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403 | 33 |
| 997515 | Allegra D 24 HR Allergy & Congestion (fexofenadine hydrochloride 180 MG / pseudoepehedrine hydrochloride 240 MG) Extended Release Oral Tablet | SY | 1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403 | 33 |
| 997515 | Allegra-D 24 Hour (fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG) Extended Release Oral Tablet | SY | 1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403 | 33 |
| 997415 | fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral Tablet | SY | 1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403 | 33 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41167-4320-7 | 41167432007 | 3 BLISTER PACK in 1 CARTON (41167-4320-7) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2011-03-03 | 0000-00-00 | No | No | Current |