Fexofenadine HCl and Pseudoephedrine HCI

Product NDC: 21130-557
11-digit product format: 211300557
Labeler code: 21130
Product ID: 21130-557_dfda3c7c-4c57-5917-ab77-7b5372ec14d2
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine HCl and Pseudoephedrine HCI
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Safeway Inc
Application: ANDA079043
Marketing category: ANDA
Marketing start: 2013-02-05
Marketing end: 0000-00-00
Substance: FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 180 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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	21130-557		I	Inactivated by FDA		2026-08-10
excluded package	package	21130-557	21130-557-35	I	Inactivated by FDA		2026-08-10

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 · 42 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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`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	21130-557-35	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL			2011-06-22

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`cb3db0bc1861…`

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
21130-557-35	2020-01-31	C162847	48780-1	9d75b9cf-f22d-f424-e053-dadaa90a57ce	Fexofenadine HCl and Pseudoephedrine HCI ER Tablets USP 180240 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21130-557-35	Fexofenadine HCl and Pseudoephedrine HCI	5 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	5		1
21130-557-35	Fexofenadine HCl and Pseudoephedrine HCI	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
ACETYLTRIBUTYL CITRATE	INACTIVE INGREDIENT	0ZBX0N59RZ	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-557	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC]	1	Legacy NDC, 2 package rows	20140218_65a92250-d0e8-c902-b14c-67f53ab26635.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine HCl and Pseudoephedrine HCl	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL	CVS Pharmacy, Inc	3a878985-3a0e-1960-db0e-e3b8fd9d5c63	2026-03-10	Warnings	Exact identifier application applno (ANDA): 079043 application number: ANDA079043
Fexofenadine HCl and Pseudoephedrine HCl	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL	Walgreens company	acc07840-a892-a3f4-331d-a211b10842df	2025-07-22	Warnings	Exact identifier application applno (ANDA): 079043 application number: ANDA079043
Fexofenadine HCl and Pseudoephedrine HCl	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL	Dr.Reddy's Laboratories Inc	d4e66d84-5ce8-36a1-7a99-2a2a0f38ce19	2025-07-22	Warnings	Exact identifier application applno (ANDA): 079043 application number: ANDA079043
Fexofenadine HCl and Pseudoephedrine HCl	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL	Walmart Inc.	883d21cd-4c5f-b502-1465-e346ecc2e2ec	2025-07-22	Warnings	Exact identifier application applno (ANDA): 079043 application number: ANDA079043
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	Dr.Reddy's Laboratories Limited	25cca459-fdd6-3847-2207-dd4f019781b5	2018-12-05	Warnings	Exact identifier application applno (ANDA): 079043 application number: ANDA079043

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
997415	fexofenadine HCl 180 MG / pseudoephedrine HCl 240 MG 24HR Extended Release Oral Tablet	PSN	65a92250-d0e8-c902-b14c-67f53ab26635	1
997415	24 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral Tablet	SCD	65a92250-d0e8-c902-b14c-67f53ab26635	1
997415	fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral Tablet	SY	65a92250-d0e8-c902-b14c-67f53ab26635	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21130-557-35	21130055735	5 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine HCl and Pseudoephedrine HCI ER Tablets USP 180240 mg	Safeway Inc	2014-02-04	HUMAN OTC DRUG LABEL	1