kirkland signature allerclear d 24 hr

Product NDC: 63981-138
11-digit product format: 639810138
Labeler code: 63981
Product ID: 63981-138_96a2d914-de06-4861-b0c9-d3e20e9c8938
Type: HUMAN OTC DRUG
Nonproprietary name: loratadine, pseudoephedrine sulfate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Costco Wholesale Company
Application: ANDA075989
Marketing category: ANDA
Marketing start: 2025-10-03
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: 2027-12-31
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: kirkland signature allerclear d 24 hr
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1117562	Internal RxNorm lookup
1369756	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
c5815ab0-cb32-41ce-9a17-1cd87a66cdde	Available on FDA.report

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 ndc (product): 63981-138
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63981-138-22	63981013822	15 BLISTER PACK in 1 CARTON (63981-138-22) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	15 blister pack	2025-10-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Costco Wholesale Corp. AllerClear ® D-24 hr Drug Facts	Costco Wholesale Company	2026-06-24	HUMAN OTC DRUG LABEL	2