ALLERGY RELIEF

Product NDC: 70000-0755
Requested package NDC: 70000-0755-1
11-digit product format: 700000755
Labeler code: 70000
Product ID: 70000-0755_4e532561-358c-e69f-e063-6394a90ad9a6
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: CARDINAL HEALTH 110, LLC. DBA LEADER
Application: ANDA206214
Marketing category: ANDA
Marketing start: 2026-03-18
Substance: LORATADINE
Active strength: 10 mg/1
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
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 · 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	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`caaa826d4ba7…`
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…`

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: ALLERGY RELIEF
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
828269	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
052e0ea2-441f-42cc-b62c-f2574f995bff	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70000-0755-1	ALLERGY RELIEF	1 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	1		4
70000-0755-1	ALLERGY RELIEF	10 in 1 CARTON	CAPSULE, LIQUID FILLED	10		4

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 ndc (package): 70000-0755-1 ndc (product): 70000-0755 ndc11 (package): 70000075501
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	052e0ea2-441f-42cc-b62c-f2574f995bff	4
828269	loratadine 10 MG Oral Capsule	SCD	052e0ea2-441f-42cc-b62c-f2574f995bff	4
828269	loratadine 10 MG 24HR Oral Capsule	SY	052e0ea2-441f-42cc-b62c-f2574f995bff	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70000-0755-1	70000075501	10 BLISTER PACK in 1 CARTON (70000-0755-1) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	10 blister pack	2026-03-18	No	No	Current