ALLEGRA-D

Product NDC: 50090-1203
Requested package NDC: 50090-1203-0
11-digit product format: 500901203
Labeler code: 50090
Product ID: 50090-1203_a0388348-fc41-4d13-81ad-d8f25cd154d9
Type: HUMAN OTC DRUG
Nonproprietary name: fexofenadine hydrochloride and pseudoephedrine hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA020786
Marketing category: NDA
Marketing start: 2011-03-03
Substance: FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 60; 120 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: 2026-12-31
Current FDA listing: Yes

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.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020786-002	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-01-24	`f41ea6bd6efb…`

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FEXOFENADINE HYDROCHLORIDE	60 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2S068B75ZU	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997406	Internal RxNorm lookup
997512	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
705e1087-61cb-43c3-8675-f56626a1707b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-1203-0	2023-02-07	C162847	48780-1	f386c649-bd09-0266-e053-dadaa90a7c1a	ALLEGRA-D
50090-1203-0	2023-01-30	C162847	48780-1	f386c649-bd09-0266-e053-dadaa90a7c1a	ALLEGRA-D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1203-0	ALLEGRA-D	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10		12
50090-1203-0	ALLEGRA-D	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1203-0	EA - Each	50090-1203	09e718f8-ee77-4044-bd71-fad849af52de	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1203	ALLEGRA-D (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]	12	Current NDC, Legacy NDC, 2 package rows	20250212_705e1087-61cb-43c3-8675-f56626a1707b.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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allegra-D Allergy and Congestion	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Chattem, Inc.	b32e172a-abf5-4c17-aa39-19e517952b91	2026-01-12	Warnings	Exact identifier application applno (NDA): 020786 application number: NDA020786
ALLEGRA-D	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	705e1087-61cb-43c3-8675-f56626a1707b	2024-01-07	Warnings	Exact identifier application applno (NDA): 020786 application number: NDA020786 ndc (package): 50090-1203-0 ndc (product): 50090-1203 ndc11 (package): 50090120300

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S068B75ZU	FEXOFENADINE HYDROCHLORIDE	153439-40-8	FEXOFENADINE HYDROCHLORIDE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
997512	Allegra-D 60 MG /120 MG 12HR Extended Release Oral Tablet	PSN	705e1087-61cb-43c3-8675-f56626a1707b	12
997406	fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	705e1087-61cb-43c3-8675-f56626a1707b	12
997512	12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Allegra-D]	SBD	705e1087-61cb-43c3-8675-f56626a1707b	12
997406	12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	705e1087-61cb-43c3-8675-f56626a1707b	12
997512	Allegra-D 12 Hour (fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG) Extended Release Oral Tablet	SY	705e1087-61cb-43c3-8675-f56626a1707b	12
997406	fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet	SY	705e1087-61cb-43c3-8675-f56626a1707b	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1203-0	50090120300	1 BLISTER PACK in 1 CARTON (50090-1203-0) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2014-11-28	0000-00-00	No	No	Current