Loratadine and Pseudoephedrine

Product NDC: 61715-016
11-digit product format: 617150016
Labeler code: 61715
Product ID: 61715-016_9edc1bd1-94f1-46a1-87bc-7f2781e4757b
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine and Pseudoephedrine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Kinray
Application: ANDA076557
Marketing category: ANDA
Marketing start: 2004-11-17
Marketing end: 0000-00-00
Substance: LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength: 10 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	61715-016		D	Discontinued by firm		2026-09-09
excluded package	package	61715-016	61715-016-15	D	Discontinued by firm		2026-09-09

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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61715-016-15	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61715-016-15	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61715-016-15	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61715-016-15	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61715-016-15	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61715-016-15	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61715-016-15	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61715-016-15	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61715-016-15	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61715-016-15	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61715-016-15	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61715-016-15	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61715-016-15	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61715-016-15	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61715-016-15	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61715-016-15	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61715-016-15	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61715-016-15	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61715-016-15	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61715-016-15	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61715-016-15	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL			2004-09-22

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 · 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	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61715-016-15	2025-05-27	C162847	48780-1	9d75b9d0-8890-f424-e053-dadaa90a57ce	Drug Facts
61715-016-15	2020-01-31	C162847	48780-1	9d75b9d0-8890-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
PSEUDOEPHEDRINE SULFATE	ACTIVE INGREDIENT	Y9DL7QPE6B	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LORATADINE AND PSEUDOEPHEDRINE TABLET, FILM COATED, EXTENDED RELEASE [KINRAY]	1

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Ohm Laboratories Inc.	556b89ef-3b51-4faa-afb4-767a5c1b6422	2026-06-02	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Sportpharm LLC	2b432b67-f9f3-45e2-8306-2d4080152f99	2026-02-06	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
ALLERGY RELIEF-D	LORATADINE AND PSEUDOEPHEDRINE	CVS Pharmacy	0b26004d-f741-48e1-bf2b-ec4af8150160	2025-11-19	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Major Pharmaceuticals	2620a150-4a2c-4fa2-a0e4-6aafe9e496c3	2025-09-08	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Ohm Laboratories Inc.	bbe83464-a582-469f-8fac-f98e804d96fe	2025-07-15	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	The Kroger Company	43e53450-9630-4161-8008-22267a785343	2025-04-24	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	WAL-MART STORES, INC	59453133-20bf-4f13-855a-b47b22302d8b	2025-04-14	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Strategic Sourcing Services LLC	cdecad62-bf1e-43fb-b4be-8fc54b63e4ae	2024-11-22	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Strategic Sourcing Services LLC	48bfc938-d97d-4b49-8637-3b00ac870902	2024-11-21	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Meijer Distribution, Inc.	eb6e2196-2f4f-4fe9-9c80-b4ce89da8db4	2023-08-23	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Kirkland-COSTCO WHOLESALE COMPANY	b8e35d9f-5ad7-4cd5-b359-18f7dfe586c6	2023-08-23	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	STRATEGIC SOURCING SERVICES LLC	07f03186-438d-41b7-a871-f05a38733329	2023-08-11	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Rite Aid	bb0f7653-378f-40b1-8ead-77999fcbd87b	2022-05-09	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Leader Allergy Relief D-24	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Cardinal Health	f1bcd2aa-e8cd-4364-87b4-c544537cdb50	2022-03-22	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Safeway Inc.	c1e1e0ca-30df-4ace-a7b6-c66a3c5ab676	2021-12-21	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Walgreen Company	ab7e4406-997a-43be-af99-a07a2da870da	2021-08-25	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	AMERISOURCE BERGEN	96635cb0-8c78-4c3a-8294-2804ff26f90a	2021-06-03	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Amerisource Bergen	3013f7b8-d87c-41ab-ba6f-c4d1b39cb1c1	2021-06-03	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	STRATEGIC SOURCING SERVICES	114b5e7c-973a-4a34-8538-a214de090b39	2020-07-30	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Proficient Rx LP	ca1a6552-d082-4312-ba17-0055e8554eb9	2019-12-01	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AJO3BO7QN	LORATADINE	79794-75-5	LORATADINE
Y9DL7QPE6B	PSEUDOEPHEDRINE SULFATE	7460-12-0	PSEUDOEPHEDRINE SULFATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Kinray \| Ranbaxy Pharmaceuticals Inc. \| Ohm Laboratories Inc.	2013-02-25	HUMAN OTC DRUG LABEL	1