Claritin

Product NDC: 67751-153
11-digit product format: 677510153
Labeler code: 67751
Product ID: 67751-153_f5db87e3-16ba-4e7e-e053-2995a90ab04e
Type: HUMAN OTC DRUG
Nonproprietary name: loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Navajo Manufacturing Company
Application: NDA019658
Marketing category: NDA
Marketing start: 2017-12-04
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67751-153	67751-153-02	D	Discontinued by firm		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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67751-153	67751-153-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67751-153	67751-153-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Claritin
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
206805	Internal RxNorm lookup
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
60a5dc14-3f74-8414-e053-2991aa0ad34a	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
67751-153-01	2023-03-01	f386c649-a621-0266-e053-dadaa90a7c1a	Claritin
67751-153-02	2023-03-01	f386c649-be97-0266-e053-dadaa90a7c1a	Claritin
67751-153-01	2023-01-30	f386c649-a621-0266-e053-dadaa90a7c1a	Claritin
67751-153-02	2023-01-30	f386c649-be97-0266-e053-dadaa90a7c1a	Claritin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67751-153-01	Claritin	1 in 1 CARTON	TABLET	1	3
67751-153-01	Claritin	1 in 1 POUCH	TABLET	1	3
67751-153-02	Claritin	12 in 1 TRAY	TABLET	12	3
67751-153-02	Claritin	1 in 1 BLISTER PACK	TABLET	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67751-153	CLARITIN (LORATADINE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]	3	Current NDC, Legacy NDC, 2 package rows	20230302_219ab9c4-d0c4-4256-ab64-66d0260886bd.zip
67751-153	CLARITIN (LORATADINE) TABLET [NAVAJO MANUFACTURING COMPANY]	3	Current NDC, Legacy NDC, 2 package rows	20230302_60a5dc14-3f74-8414-e053-2991aa0ad34a.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 ndc (product): 67751-153
Claritin	LORATADINE	Navajo Manufacturing Company Inc.	219ab9c4-d0c4-4256-ab64-66d0260886bd	2023-03-01	Warnings	Exact identifier application applno (NDA): 019658 application number: NDA019658 ndc (product): 67751-153

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	219ab9c4-d0c4-4256-ab64-66d0260886bd	3
206805	Claritin 24HR Allergy 10 MG Oral Tablet	PSN	60a5dc14-3f74-8414-e053-2991aa0ad34a	3
311372	loratadine 10 MG 24HR Oral Tablet	PSN	219ab9c4-d0c4-4256-ab64-66d0260886bd	3
311372	loratadine 10 MG 24HR Oral Tablet	PSN	60a5dc14-3f74-8414-e053-2991aa0ad34a	3
206805	loratadine 10 MG Oral Tablet [Claritin]	SBD	219ab9c4-d0c4-4256-ab64-66d0260886bd	3
206805	loratadine 10 MG Oral Tablet [Claritin]	SBD	60a5dc14-3f74-8414-e053-2991aa0ad34a	3
311372	loratadine 10 MG Oral Tablet	SCD	219ab9c4-d0c4-4256-ab64-66d0260886bd	3
311372	loratadine 10 MG Oral Tablet	SCD	60a5dc14-3f74-8414-e053-2991aa0ad34a	3
206805	Claritin 10 MG 24 HR Oral Tablet	SY	219ab9c4-d0c4-4256-ab64-66d0260886bd	3
206805	Claritin 10 MG 24 HR Oral Tablet	SY	60a5dc14-3f74-8414-e053-2991aa0ad34a	3
206805	Claritin 10 MG Oral Tablet	SY	219ab9c4-d0c4-4256-ab64-66d0260886bd	3
206805	Claritin 10 MG Oral Tablet	SY	60a5dc14-3f74-8414-e053-2991aa0ad34a	3
311372	loratadine 10 MG 24 HR Oral Tablet	SY	219ab9c4-d0c4-4256-ab64-66d0260886bd	3
311372	loratadine 10 MG 24 HR Oral Tablet	SY	60a5dc14-3f74-8414-e053-2991aa0ad34a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67751-153-01	67751015301	1 POUCH in 1 CARTON (67751-153-01) / 1 TABLET in 1 POUCH	1 pouch	2016-09-17	0000-00-00	No	No	Current
67751-153-02	67751015302	12 BLISTER PACK in 1 TRAY (67751-153-02) > 1 TABLET in 1 BLISTER PACK	12 blister pack	2017-12-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Claritin	Navajo Manufacturing Company Inc.	2023-03-01	HUMAN OTC DRUG LABEL	3
Claritin	Navajo Manufacturing Company \| Navajo Manufacturing Company Inc.	2023-03-01	HUMAN OTC DRUG LABEL	3