Claritin

Manufacturer: Navajo Manufacturing Company Inc.
Effective date: 2023-03-01
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:54:19

Label at a glance#

ProductClaritin

Active ingredientLORATADINE

Label structure8 sections

Indications and uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

Dosage and administration

adults and Children 12 years and older 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney diseases Ask a doctor

Contacts and useful links#

PhoneLabel contact1-800-252-7484

Websitewww.claritin.com

www.claritin.com

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose • itchy, watery eyes
• sneezing • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and Children 12 years and older	1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney diseases	Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

• safety sealed: do not use if the individual blister unit imprinted with Claritin® is open or torn
• store between 20° to 25° C (68° to 77° F)
• protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, lactose monohydrate, magnesium stearate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Claritin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
206805	Claritin 24HR Allergy 10 MG Oral Tablet	PSN	3
311372	loratadine 10 MG 24HR Oral Tablet	PSN	3
206805	loratadine 10 MG Oral Tablet [Claritin]	SBD	3
311372	loratadine 10 MG Oral Tablet	SCD	3
206805	Claritin 10 MG 24 HR Oral Tablet	SY	3
206805	Claritin 10 MG Oral Tablet	SY	3
311372	loratadine 10 MG 24 HR Oral Tablet	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67751-153-01	2023-03-01	C162847	48780-1	f386c649-a621-0266-e053-dadaa90a7c1a	Claritin
67751-153-01	2023-01-30	C162847	48780-1	f386c649-a621-0266-e053-dadaa90a7c1a	Claritin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67751-153-01	Claritin	1 in 1 CARTON	TABLET	1		3
67751-153-01	Claritin	1 in 1 POUCH	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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-7160-1	EA - Each	11523-7160	855a386e-d048-4eb2-bd46-2879970928ae	1	2013-02-13
11523-7160-2	EA - Each	11523-7160	f16535e3-da09-49d8-a400-b4328a9b0ac1	1	2013-02-13
11523-7160-3	EA - Each	11523-7160	6bdfb32c-53ad-4c7d-85d1-51ff7fa065b7	1	2013-02-13
11523-7160-5	EA - Each	11523-7160	a1906c20-1d1d-43af-93a8-9e8abdde3f0c	1	2013-02-13
11523-7160-9	EA - Each	11523-7160	daafcf57-7015-4018-af3f-c0d07661841f	1	2024-05-16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Claritin
LORATADINE
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67751-153	67751-153-01
11523-7160

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
STARCH, CORN	O8232NY3SJ	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
LORATADINE	7AJO3BO7QN	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`caaa826d4ba7…`
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…`

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 · 3 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 ndc (product): 11523-7160
Claritin	LORATADINE	Navajo Manufacturing Company	60a5dc14-3f74-8414-e053-2991aa0ad34a	2023-03-01	Warnings	Exact identifier ndc (product): 67751-153
Claritin	LORATADINE	Navajo Manufacturing Company Inc.	219ab9c4-d0c4-4256-ab64-66d0260886bd	2023-03-01	Warnings	Exact identifier ndc (package): 67751-153-01 ndc (product): 67751-153 ndc11 (package): 67751015301 spl id: f5db88bd-8ea6-0df0-e053-2995a90a18b4 spl set id: 219ab9c4-d0c4-4256-ab64-66d0260886bd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.