Fexofenadine HCl and Pseudoephedrine HCI

Product NDC: 37808-022
11-digit product format: 378080022
Labeler code: 37808
Product ID: 37808-022_8c74b0a5-6bbc-0f8d-bbda-46d6cb39aea6
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine HCl and Pseudoephedrine HCI
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: HEB
Application: ANDA076667
Marketing category: ANDA
Marketing start: 2015-12-21
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL			2014-11-18

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fexofenadine HCl and Pseudoephedrine HCI
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997406	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
0de7fc37-7f46-4e98-d5ac-d31a3c313a62	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37808-022-31	Fexofenadine HCl and Pseudoephedrine HCI	6 in 1 CARTON	TABLET, EXTENDED RELEASE	6		3
37808-022-31	Fexofenadine HCl and Pseudoephedrine HCI	5 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	5		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-022	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [HEB]	3	Current NDC, Legacy NDC, 2 package rows	20171208_0de7fc37-7f46-4e98-d5ac-d31a3c313a62.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	Dr. Reddy's Laboratories Limited	728632be-7e5c-2d06-4c95-bc8ecc9be2ec	2024-12-19	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667
Allergy and Congestion	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	Rite Aid Corporation	90e1aa06-b769-e8ac-af88-1d6a256b9487	2020-05-19	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	Dr. Reddy's Laboratories Inc.	6fd05737-d996-b5b6-dccf-bc179a9d606c	2019-09-09	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	The Kroger Co.	8cf0b878-ec13-fd44-d56f-f44af7c249ed	2018-10-01	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	The Kroger Co.	cb9e98a9-74e6-7a3e-9c5e-3bc35c4bbca6	2017-12-07	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	HEB	0de7fc37-7f46-4e98-d5ac-d31a3c313a62	2017-12-07	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667 ndc (product): 37808-022
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	CVS Pharmacy	3e295047-1a46-a0d8-2e3f-ec4086f5aedb	2015-08-24	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	Walgreens Company	37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b3	2015-08-04	Warnings	Exact identifier application applno (ANDA): 076667 application number: ANDA076667

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	0de7fc37-7f46-4e98-d5ac-d31a3c313a62	3
997406	12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	0de7fc37-7f46-4e98-d5ac-d31a3c313a62	3
997406	fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet	SY	0de7fc37-7f46-4e98-d5ac-d31a3c313a62	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-022-31	37808002231	6 BLISTER PACK in 1 CARTON (37808-022-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	6 blister pack	2015-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine HCl 60 mg and Pseudoephedrine HCI 120 mg ER Tablets USP	HEB	2017-12-07	HUMAN OTC DRUG LABEL	3