Allergy Relief

Product NDC: 63868-462
11-digit product format: 638680462
Labeler code: 63868
Product ID: 63868-462_847b0a98-4af6-45a3-aead-f499125080a8
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: ANDA075209
Marketing category: ANDA
Marketing start: 2019-02-28
Marketing end: 2025-02-28
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63868-462		D	Discontinued by firm	2026-08-10
excluded package	package	63868-462	63868-462-01	D	Discontinued by firm	2026-08-10
excluded package	package	63868-462	63868-462-10	D	Discontinued by firm	2026-08-10
excluded package	package	63868-462	63868-462-30	D	Discontinued by firm	2026-08-10

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63868-462-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63868-462-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63868-462-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63868-462-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63868-462-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63868-462-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63868-462-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63868-462-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63868-462-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63868-462-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63868-462-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63868-462-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63868-462-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63868-462-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63868-462-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63868-462-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63868-462-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63868-462-30	`cdf11ea48f46…`	`ba0047e9e063…`

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
A075209-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2003-01-21

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	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63868-462-01	2020-11-30	Drug Facts
63868-462-10	2020-11-30	Drug Facts
63868-462-30	2020-11-30	Drug Facts
63868-462-01	2020-09-27	Drug Facts
63868-462-10	2020-09-27	Drug Facts
63868-462-30	2020-09-27	Drug Facts
63868-462-01	2020-09-25	Drug Facts
63868-462-10	2020-09-25	Drug Facts
63868-462-30	2020-09-25	Drug Facts
63868-462-01	2020-07-22	Drug Facts
63868-462-10	2020-07-22	Drug Facts
63868-462-30	2020-07-22	Drug Facts

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
All Day Allergy Relief	LORATADINE	WALMART INC. (see also Equate)	db815af2-4193-4fd9-a028-4a9d54325ca8	2026-06-18	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
All Day Allergy Relief	LORATADINE	WALMART INC. (see also Equate)	80958503-400c-422a-a641-e1a3d5a9a6a8	2026-04-17	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Loratadine	LORATADINE	NuCare Pharmaceuticals,Inc.	c0e3057d-2dd2-de2b-e053-2995a90a1a1d	2026-03-05	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
All Day Allergy Relief	LORATADINE	Safeway, Inc.	9e581ae1-d1e6-4038-86e8-fd0c5ab9878a	2026-01-05	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Claritin	LORATADINE	Select Consumer Group	3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e	2025-12-28	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Claritin	LORATADINE	Bayer HealthCare LLC.	acf2d393-53d7-062f-e053-2995a90a0d60	2025-12-04	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Claritin	LORATADINE	Bayer HealthCare LLC.	dc65f7ec-bb83-7b29-e053-2995a90a99de	2025-12-04	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
All Day Allergy Relief	LORATADINE	Family Dollar (FAMILY WELLNESS)	6b8d786e-2ee3-487f-bf7b-7dc738ea2fc9	2025-10-29	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Allergy relief	LORATADINE	Preferred Pharmaceuticals Inc.	836f566c-0296-408a-ad2a-6a77e1855218	2025-08-29	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Wal-itin	LORATADINE	Walgreens	6afa8056-1b7a-48a4-960c-92927169977e	2025-08-28	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Allergy relief	LORATADINE	Geri-Care Pharmaceutical Corp	b66f171a-7b95-b27a-e053-2a95a90a6009	2025-07-28	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Allergy Relief	LORATADINE	WinCo Foods, LLC	706a59fa-3d15-4e6e-a38e-ad3f2ef46600	2025-04-08	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
CounterAct Allergy	LORATADINE	Melaleuca, Inc.	6b5d43ad-a709-4e0b-b91c-36ea0afe7221	2025-03-17	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Allergy relief	LORATADINE	Bryant Ranch Prepack	e87aa69c-9ec6-482d-8e28-32542f6b9166	2025-02-04	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Allergy relief	LORATADINE	A-S Medication Solutions	210fa77a-e33e-48c4-8228-b1cf3ccb7fa4	2025-01-30	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Claritin	LORATADINE TABLET	Lil' Drug Store Products, Inc.	f0e77162-c601-1a0f-e053-2a95a90ab714	2024-12-31	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
All Day Allergy Relief	LORATADINE	QUALITY CHOICE (Chain Drug Marketing Association)	a282d209-1015-4570-b9df-7cc0a3753e37	2024-06-17	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Allergy Relief	LORATADINE	QUALITY CHOICE (Chain Drug Marketing Association)	c5acd9d7-2f26-41c5-b369-2122251583ec	2024-05-17	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
All Day Allergy Relief	LORATADINE	QUALITY CHOICE (Chain Drug Marketing Association)	d47a5f1b-fb27-4618-a26e-a5eeabcd87f2	2024-05-16	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
All Day Allergy Relief	LORATADINE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	7eac9202-bd4c-4550-a257-2b8195a0dbcd	2023-11-29	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-462-01	63868046201	1 BOTTLE, PLASTIC in 1 BOX (63868-462-01) > 100 TABLET in 1 BOTTLE, PLASTIC		2019-02-28	0000-00-00	No	No	Current
63868-462-10	63868046210	10 BLISTER PACK in 1 CARTON (63868-462-10) > 1 TABLET in 1 BLISTER PACK	10 blister pack	2019-02-28	0000-00-00	No	No	Current
63868-462-30	63868046230	1 BOTTLE, PLASTIC in 1 BOX (63868-462-30) > 30 TABLET in 1 BOTTLE, PLASTIC		2019-02-28	0000-00-00	No	No	Current