FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE

Product NDC: 21695-820
11-digit product format: 216950820
Labeler code: 21695
Product ID: 21695-820_e4020ca3-82d0-4668-b4bc-92e4a53c1f4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA020786
Marketing category: NDA
Marketing start: 2009-11-02
Marketing end: 0000-00-00
Substance: FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 60 mg/1; mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-820		I	Inactivated by FDA		2026-10-12
excluded package	package	21695-820	21695-820-14	I	Inactivated by FDA		2026-10-12

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-820-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-820-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-820-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-820-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-820-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-820-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-820-14	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-820-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-820-14	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-820-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-820-14	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-820-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-820-14	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-820-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-820-14	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-820-14	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-820-14	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-820-14	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-820-14	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-820-14	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-820-14	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-820-14	`110d247fa046…`	`a55b01930146…`

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.

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
21695-820-14	2019-09-24	C162847	48780-1	934fe258-4989-48b1-e053-8cdaa90a720a	Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-820-14	FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE	14 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	14		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-820	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110414_e4020ca3-82d0-4668-b4bc-92e4a53c1f4e.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

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
997406	fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	e4020ca3-82d0-4668-b4bc-92e4a53c1f4e	1
997406	12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	e4020ca3-82d0-4668-b4bc-92e4a53c1f4e	1
997406	fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet	SY	e4020ca3-82d0-4668-b4bc-92e4a53c1f4e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-820-14	21695082014	14 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets	Rebel Distributors Corp	2011-04-13	HUMAN PRESCRIPTION DRUG LABEL	1