Allergy Relief

Product NDC: 50804-840
11-digit product format: 508040840
Labeler code: 50804
Product ID: 50804-840_458c2295-eb05-1ae6-e063-6394a90a6c79
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: GOODSENSE
Application: ANDA206214
Marketing category: ANDA
Marketing start: 2018-12-01
Marketing end: 2026-07-31
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Current FDA listing: Yes

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	50804-840		D	Discontinued by firm		2026-08-10
excluded package	package	50804-840	50804-840-10	D	Discontinued by firm		2026-08-10

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
A206214-001	LORATADINE	LORATADINE	10MG	CAPSULE / ORAL			2016-09-23

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	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`cb3db0bc1861…`

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50804-840-10	Allergy Relief	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1		5
50804-840-10	Allergy Relief	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50804-840-10	EA - Each	50804-840	0a56ab1b-4cbb-4cbe-aec3-71089f880d4e	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50804-840	ALLERGY RELIEF (LORATADINE) CAPSULE, LIQUID FILLED [GOODSENSE]	4	Current NDC, Legacy NDC, 2 package rows	20221124_969b7d4b-fb07-4f44-af71-3e5eed922793.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALLERGY RELIEF	LORATADINE	CARDINAL HEALTH 110, LLC. DBA LEADER	052e0ea2-441f-42cc-b62c-f2574f995bff	2026-03-31	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214
LORATADINE	LORATADINE	CVS HEALTH CORP	899800a7-89bc-4a39-88b0-f19d78934daf	2026-03-26	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214
LORATADINE	LORATADINE	KROGER COMPANY	0599cc64-419d-452f-ac50-ac0311006729	2025-12-29	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214
Allergy Relief	LORATADINE	Safeway	8a1b3d40-8ec4-7e76-e053-2a95a90a84b1	2025-04-30	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214
ALLERGY RELIEF	LORATADINE	TARGET CORPORATION	7cb1364b-0852-3444-e053-2991aa0a3629	2025-02-01	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214
Allergy Relief	LORATADINE	CHAIN DRUG MARKETING ASSOCIATION, INC.	e0cb8057-4755-482d-84f4-9275f7b85cd0	2024-08-12	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214
WAL-ITIN	LORATADINE	WALGREENS	9e155aae-4735-4aab-bda9-c21ea29529a4	2022-11-11	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214
Loratadine	LORATADINE	MARKSANS PHARMA LIMITED	c30907f9-1761-41e5-bd4e-2613e756e1c6	2021-11-15	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214
LORATADINE	LORATADINE	SMART SENSE (KMART)	c2db3398-ead6-4bb6-8aa6-f1366a846144	2018-05-16	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214
LORATADINE	LORATADINE	TIME CAP LABORATORIES INC	85b26cf3-448c-4d4f-93a2-aa89530ec1f1	2018-05-16	Warnings	Exact identifier application applno (ANDA): 206214 application number: ANDA206214

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AJO3BO7QN	LORATADINE	79794-75-5	LORATADINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
828269	loratadine 10 MG 24HR Oral Capsule	PSN	969b7d4b-fb07-4f44-af71-3e5eed922793	5
828269	loratadine 10 MG Oral Capsule	SCD	969b7d4b-fb07-4f44-af71-3e5eed922793	5
828269	loratadine 10 MG 24HR Oral Capsule	SY	969b7d4b-fb07-4f44-af71-3e5eed922793	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50804-840-10	50804084010	1 BLISTER PACK in 1 CARTON (50804-840-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 blister pack	2018-12-01	2026-07-31	No	No	Current