topcare allergy and congestion relief

Product NDC: 36800-706
11-digit product format: 368000706
Labeler code: 36800
Product ID: 36800-706_790d8277-d9af-46bb-ae3a-dfbf49b3d1be
Type: HUMAN OTC DRUG
Nonproprietary name: loratadine, pseudoephedrine sulfate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Topco Associates LLC
Application: ANDA075989
Marketing category: ANDA
Marketing start: 2023-08-16
Substance: LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength: 10; 240 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], 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 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
A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL			2004-03-04

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075989-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-03-04	`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: topcare allergy and congestion relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	10 mg/1
PSEUDOEPHEDRINE SULFATE	240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7AJO3BO7QN	Internal UNII lookup
Y9DL7QPE6B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1117562	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
32945cd9-60d4-4dc0-96e6-9ed28ffce3fb	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-706-22	topcare allergy and congestion relief	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1		2
36800-706-22	topcare allergy and congestion relief	15 in 1 CARTON	TABLET, EXTENDED RELEASE	15		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-706	TOPCARE ALLERGY AND CONGESTION RELIEF (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]	2	Current NDC, 2 package rows	20231018_32945cd9-60d4-4dc0-96e6-9ed28ffce3fb.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
kirkland signature allerclear d 24 hr	LORATADINE, PSEUDOEPHEDRINE SULFATE	Costco Wholesale Company	c5815ab0-cb32-41ce-9a17-1cd87a66cdde	2026-06-24	Warnings	Exact identifier application applno (ANDA): 075989 application number: ANDA075989
Allergy Relief D	LORATADINE, PSEUDOEPHEDRINE SULFATE	Walgreen Company	9952e0fb-b20e-4f9c-8be7-aa286e271fee	2026-02-28	Warnings	Exact identifier application applno (ANDA): 075989 application number: ANDA075989
allergy d	LORATADINE, PSEUDOEPHEDRINE SULFATE	L. Perrigo Company	512f8f46-5c62-470d-b14a-93b86ec34ce8	2025-10-03	Warnings	Exact identifier application applno (ANDA): 075989 application number: ANDA075989
allergy congestion relief	LORATADINE, PSEUDOEPHEDRINE SULFATE	Kroger Company	2dde77f9-72c4-42b4-aaaa-0bc300dffc37	2024-02-27	Warnings	Exact identifier application applno (ANDA): 075989 application number: ANDA075989
topcare allergy and congestion relief	LORATADINE, PSEUDOEPHEDRINE SULFATE	Topco Associates LLC	32945cd9-60d4-4dc0-96e6-9ed28ffce3fb	2023-08-29	Warnings	Exact identifier application applno (ANDA): 075989 application number: ANDA075989 ndc (product): 36800-706

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1117562	pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral Tablet	PSN	32945cd9-60d4-4dc0-96e6-9ed28ffce3fb	2
1117562	24 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet	SCD	32945cd9-60d4-4dc0-96e6-9ed28ffce3fb	2
1117562	loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral Tablet	SY	32945cd9-60d4-4dc0-96e6-9ed28ffce3fb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
36800-706-22	36800070622	15 BLISTER PACK in 1 CARTON (36800-706-22) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	15 blister pack	2023-08-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Allergy & Congestion Relief Drug Facts	Topco Associates LLC	2023-08-29	HUMAN OTC DRUG LABEL	2