allergy relief

Product NDC: 0363-1612
11-digit product format: 003631612
Labeler code: 0363
Product ID: 0363-1612_eff828bf-472b-4f68-a285-a7952c1d4a56
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Walgreen Company
Application: ANDA076301
Marketing category: ANDA
Marketing start: 2021-10-21
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	0363-1612	0363-1612-46	D	Discontinued by firm	2026-10-15
excluded package	package	0363-1612	0363-1612-60	D	Discontinued by firm	2026-10-15
excluded package	package	0363-1612	0363-1612-75	D	Discontinued by firm	2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0363-1612-46	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-1612-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-1612-46	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-1612-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-1612-46	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-1612-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-1612-46	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-1612-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-1612-46	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-1612-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-1612-46	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-1612-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-1612-46	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-1612-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-1612-46	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-1612-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-1612-46	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-1612-60	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A076301-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2004-06-25

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3a93d1ddd44b…`

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
311372	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
41f8fc1d-2d14-48da-a233-23e9c11296d9	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-1612-03	allergy relief	70 in 1 BOTTLE	TABLET	70	6
0363-1612-03	allergy relief	1 in 1 CARTON	TABLET	1	6
0363-1612-46	allergy relief	10 in 1 CARTON	TABLET	10	6
0363-1612-46	allergy relief	1 in 1 BLISTER PACK	TABLET	1	6
0363-1612-47	allergy relief	150 in 1 BOTTLE	TABLET	150	6
0363-1612-47	allergy relief	1 in 1 CARTON	TABLET	1	6
0363-1612-58	allergy relief	40 in 1 BOTTLE	TABLET	40	6
0363-1612-58	allergy relief	1 in 1 CARTON	TABLET	1	6
0363-1612-60	allergy relief	20 in 1 CARTON	TABLET	20	6
0363-1612-60	allergy relief	1 in 1 BLISTER PACK	TABLET	1	6
0363-1612-65	allergy relief	1 in 1 CARTON	TABLET	1	6
0363-1612-65	allergy relief	30 in 1 BOTTLE	TABLET	30	6
0363-1612-75	allergy relief	1 in 1 CARTON	TABLET	1	6
0363-1612-75	allergy relief	90 in 1 BOTTLE	TABLET	90	6
0363-1612-78	allergy relief	1 in 1 CARTON	TABLET	1	6
0363-1612-78	allergy relief	100 in 1 BOTTLE	TABLET	100	6
0363-1612-88	allergy relief	365 in 1 BOTTLE	TABLET	365	6
0363-1612-88	allergy relief	1 in 1 CARTON	TABLET	1	6
0363-1612-95	allergy relief	1 in 1 CARTON	TABLET	1	6
0363-1612-95	allergy relief	45 in 1 BOTTLE	TABLET	45	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-1612	ALLERGY RELIEF (LORATADINE) TABLET [WALGREEN COMPANY]	6	Current NDC, Legacy NDC, 20 package rows	20250403_41f8fc1d-2d14-48da-a233-23e9c11296d9.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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Allergy Relief	LORATADINE	Cardinal Health 110, LLC. dba Leader	6f5134c6-ece6-4e35-a0c3-13e0dfa173fa	2025-04-01	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
up and up allergy relief	LORATADINE	Target Corporation	c4ef0110-89c3-4ded-9a9a-75c0f794f869	2025-03-28	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
TopCare Allergy Relief 24 hour	LORATADINE	Topco Associates LLC	a500aebf-a020-4da9-afdb-a699077cb8e1	2025-03-28	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	NuCare Pharmaceuticals,Inc.	fc63689e-e449-ca8f-e053-6394a90a54a2	2025-02-05	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	NuCare Pharmaceuticals,Inc.	54b37bcc-a8b0-0c17-e054-00144ff8d46c	2025-01-09	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
foster and thrive allergy relief	LORATADINE	Strategic Sourcing Services LLC	aff1ab34-51b0-488c-931e-c95aad226572	2024-12-11	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good neighbor pharmacy loratadine	LORATADINE	Amerisource Bergen	9dda0f0b-fbab-47ee-8db8-95bd126fc61c	2024-12-11	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
exchange select allergy relief	LORATADINE	Army & Air Force Exchange Service	ea5622d9-4e71-4a1f-9200-6b4cecac1215	2024-12-02	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	A-S Medication Solutions	9cc3d50a-81ce-4c9d-9721-209169a332e0	2024-08-21	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
allergy relief	LORATADINE	Meijer Distribution Inc	9261a02b-db43-462f-9f06-fb5624070e20	2024-08-06	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	Aphena Pharma Solutions - Tennessee, LLC	a2c92766-df4e-4414-9c42-e18bcf9db6b4	2024-04-09	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	A-S Medication Solutions	c288d849-59c9-4883-aac4-bae54acee8ac	2024-03-27	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
members mark allergy relief	LORATADINE	Sam's West Inc	95c2b45a-d0e5-467c-aad4-7bbb6c9a5204	2024-03-11	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	A-S Medication Solutions	5fda4906-4133-4293-8b39-4ddcf8d39801	2024-02-04	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
kirkland signature allerclear	LORATADINE	Costco Wholesale Company	2074d52e-8c0a-4e69-bfb1-864ffc07e25f	2024-01-17	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
equate allergy relief	LORATADINE	Wal-Mart Stores Inc	dd36dc43-a9b7-4cda-86e0-9283d996a60a	2022-12-05	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
basic care allergy relief	LORATADINE	Amazon.com Services LLC	a4a7f024-972b-4a16-9cb8-28954c2a74c6	2022-10-18	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	Proficient Rx LP	e9b87f79-ebed-4677-8e50-00cb4282ee56	2022-04-01	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine	LORATADINE	Aphena Pharma Solutions - Tennessee, LLC	8ffe2faf-3253-4121-a069-6f46e319c6f0	2020-05-13	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	L. Perrigo Company	74bed4ad-5afe-4293-bef3-e0b9d5f64a29	2019-12-05	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301

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
311372	loratadine 10 MG 24HR Oral Tablet	PSN	41f8fc1d-2d14-48da-a233-23e9c11296d9	6
311372	loratadine 10 MG Oral Tablet	SCD	41f8fc1d-2d14-48da-a233-23e9c11296d9	6
311372	loratadine 10 MG 24 HR Oral Tablet	SY	41f8fc1d-2d14-48da-a233-23e9c11296d9	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-1612-03	00363161203	1 BOTTLE in 1 CARTON (0363-1612-03) / 70 TABLET in 1 BOTTLE	1 bottle	2022-04-04	0000-00-00	No	No	Current
0363-1612-46	00363161246	10 BLISTER PACK in 1 CARTON (0363-1612-46) > 1 TABLET in 1 BLISTER PACK	10 blister pack	2021-10-21	0000-00-00	No	No	Current
0363-1612-47	00363161247	1 BOTTLE in 1 CARTON (0363-1612-47) / 150 TABLET in 1 BOTTLE	1 bottle	2021-10-21	0000-00-00	No	No	Current
0363-1612-58	00363161258	1 BOTTLE in 1 CARTON (0363-1612-58) / 40 TABLET in 1 BOTTLE	1 bottle	2024-12-10		No	No	Current
0363-1612-60	00363161260	20 BLISTER PACK in 1 CARTON (0363-1612-60) > 1 TABLET in 1 BLISTER PACK	20 blister pack	2021-10-21	0000-00-00	No	No	Current
0363-1612-65	00363161265	1 BOTTLE in 1 CARTON (0363-1612-65) / 30 TABLET in 1 BOTTLE	1 bottle	2021-10-21	0000-00-00	No	No	Current
0363-1612-75	00363161275	1 BOTTLE in 1 CARTON (0363-1612-75) > 90 TABLET in 1 BOTTLE	1 bottle	2021-12-07	0000-00-00	No	No	Current
0363-1612-78	00363161278	1 BOTTLE in 1 CARTON (0363-1612-78) / 100 TABLET in 1 BOTTLE	1 bottle	2024-12-10		No	No	Current
0363-1612-88	00363161288	1 BOTTLE in 1 CARTON (0363-1612-88) / 365 TABLET in 1 BOTTLE	1 bottle	2022-03-08	0000-00-00	No	No	Current
0363-1612-95	00363161295	1 BOTTLE in 1 CARTON (0363-1612-95) / 45 TABLET in 1 BOTTLE	1 bottle	2024-08-23		No	No	Current