allergy relief

Product NDC: 79481-0446
11-digit product format: 794810446
Labeler code: 79481
Product ID: 79481-0446_73b95703-51ba-4e0e-a343-00e24ef815c3
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Meijer, Inc.
Application: ANDA202538
Marketing category: ANDA
Marketing start: 2020-07-14
Substance: LORATADINE
Active strength: 10 mg/1
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 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
A202538-001	LORATADINE	LORATADINE	10MG	CAPSULE / ORAL			2018-12-21

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	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: allergy relief
Listing expiration: 2026-12-31

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
14f3d1a2-eda7-432a-8fe0-5437b95bdde6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79481-0446-0	allergy relief	1 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	1		4
79481-0446-0	allergy relief	30 in 1 CARTON	CAPSULE, LIQUID FILLED	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79481-0446	ALLERGY RELIEF (LORATADINE) CAPSULE, LIQUID FILLED [MEIJER, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20250221_14f3d1a2-eda7-432a-8fe0-5437b95bdde6.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dg health allergy relief	LORATADINE	Dolgencorp Inc	086a0a53-7092-4dc8-9c5e-0bd78337fedf	2025-03-11	Warnings	Exact identifier application applno (ANDA): 202538 application number: ANDA202538
allergy relief	LORATADINE	Meijer, Inc.	14f3d1a2-eda7-432a-8fe0-5437b95bdde6	2025-02-14	Warnings	Exact identifier application applno (ANDA): 202538 application number: ANDA202538 ndc (product): 79481-0446
topcare allergy relief	LORATADINE	Topco Associates LLC	5cc2e469-9080-4beb-804d-187fc335ccdc	2025-02-10	Warnings	Exact identifier application applno (ANDA): 202538 application number: ANDA202538
LORATADINE	LORATADINE	Bionpharma Inc.	4fa705fb-859e-4046-b153-a8338c50a97d	2024-12-23	Warnings	Exact identifier application applno (ANDA): 202538 application number: ANDA202538
Basic Care Allergy Relief	LORATADINE	Amazon.com Services LLC	2a834b33-5759-4e54-9adc-379310656dee	2020-08-19	Warnings	Exact identifier application applno (ANDA): 202538 application number: ANDA202538
LORATADINE	LORATADINE	Bionpharma Inc.	59bebce3-2b82-4521-a796-2d4c83bcf669	2019-01-08	Warnings	Exact identifier application applno (ANDA): 202538 application number: ANDA202538

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	14f3d1a2-eda7-432a-8fe0-5437b95bdde6	4
828269	loratadine 10 MG Oral Capsule	SCD	14f3d1a2-eda7-432a-8fe0-5437b95bdde6	4
828269	loratadine 10 MG 24HR Oral Capsule	SY	14f3d1a2-eda7-432a-8fe0-5437b95bdde6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79481-0446-0	79481044600	30 BLISTER PACK in 1 CARTON (79481-0446-0) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	30 blister pack	2020-07-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Allergy Relief Drug Facts	Meijer, Inc.	2025-02-14	HUMAN OTC DRUG LABEL	4