Claritin

Product NDC: 52904-630
Requested package NDC: 52904-630-03
11-digit product format: 529040630
Labeler code: 52904
Product ID: 52904-630_c9fb571f-a54e-442b-adeb-9b6fbc75fea9
Type: HUMAN OTC DRUG
Nonproprietary name: loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Select Corporation
Application: NDA019658
Marketing category: NDA
Marketing start: 2011-12-15
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52904-630	52904-630-03	I	Inactivated by FDA		2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019658-002	CLARITIN	LORATADINE	10MG	TABLET / ORAL		RLD, RS	2002-11-27
N019658-003	CLARITIN HIVES RELIEF	LORATADINE	10MG	TABLET / ORAL		RLD, RS	2003-11-19

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52904-630-03	2024-01-30	C162847	48780-1	1030e365-2b5c-111a-e063-dadaa90a10e2	Claritin ®
52904-630-20	2024-01-30	C162847	48780-1	1030e365-2b5c-111a-e063-dadaa90a10e2	Claritin ®
52904-630-25	2024-01-30	C162847	48780-1	1030e365-2b5c-111a-e063-dadaa90a10e2	Claritin ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52904-630-03	Claritin	1 in 1 BLISTER PACK	TABLET	1	2
52904-630-03	Claritin	1 in 1 POUCH	TABLET	1	2
52904-630-20	Claritin	20 in 1 CARTON	TABLET	20	2
52904-630-20	Claritin	1 in 1 POUCH	TABLET	1	2
52904-630-25	Claritin	25 in 1 CARTON	TABLET	25	2
52904-630-25	Claritin	1 in 1 POUCH	TABLET	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52904-630	CLARITIN (LORATADINE) TABLET [SELECT CORPORATION]	2	Legacy NDC, 6 package rows	20220609_677bf76d-e75d-4212-b1f2-eaaf25b27cb7.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
Claritin	LORATADINE	Bayer HealthCare LLC.	660ac9df-f1b1-4c89-94dd-9fae0a013f3c	2025-12-05	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658
Claritin	LORATADINE	Bayer HealthCare LLC	ac32d6f9-f553-4d5c-ad36-575af5ea56de	2025-12-04	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658
Claritin	LORATADINE	R J General Corporation	a34e8cb7-4fdf-45be-b288-45d93eef6220	2025-11-17	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658
Claritin, BSX Non-Drowsy, 24 Hour	LORATADINE	Lil' Drug Store Products, Inc	f85b0527-107c-4a4a-aad7-61d2f52bad63	2023-03-17	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658
Claritin	LORATADINE	Navajo Manufacturing Company	60a5dc14-3f74-8414-e053-2991aa0ad34a	2023-03-01	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658
Claritin	LORATADINE	Navajo Manufacturing Company Inc.	219ab9c4-d0c4-4256-ab64-66d0260886bd	2023-03-01	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658

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
206805	Claritin 24HR Allergy 10 MG Oral Tablet	PSN	677bf76d-e75d-4212-b1f2-eaaf25b27cb7	2
311372	loratadine 10 MG 24HR Oral Tablet	PSN	677bf76d-e75d-4212-b1f2-eaaf25b27cb7	2
206805	loratadine 10 MG Oral Tablet [Claritin]	SBD	677bf76d-e75d-4212-b1f2-eaaf25b27cb7	2
311372	loratadine 10 MG Oral Tablet	SCD	677bf76d-e75d-4212-b1f2-eaaf25b27cb7	2
206805	Claritin 10 MG 24 HR Oral Tablet	SY	677bf76d-e75d-4212-b1f2-eaaf25b27cb7	2
206805	Claritin 10 MG Oral Tablet	SY	677bf76d-e75d-4212-b1f2-eaaf25b27cb7	2
311372	loratadine 10 MG 24 HR Oral Tablet	SY	677bf76d-e75d-4212-b1f2-eaaf25b27cb7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52904-630-03	52904063003	1 POUCH in 1 BLISTER PACK (52904-630-03) > 1 TABLET in 1 POUCH	1 pouch	2011-12-15	0000-00-00	No	No	Current