Claritin

Manufacturer: Bayer HealthCare LLC.
Effective date: 2026-02-06
Label type: HUMAN OTC DRUG LABEL
Version: 13
Source: full-release
Hydrated at: 2026-06-01 01:37:18

Label at a glance#

ProductClaritin Liqui-Gels

Active ingredientLORATADINE

Label structure12 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 6 years and over 1 capsule daily; not more than 1 capsule in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-252-7484

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and over	1 capsule daily; not more than 1 capsule in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

caprylic/capric glycerides, FD&C blue no.1, gelatin, glycerin, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-800-CLARITIN (1-800-252-7484)

SPL UNCLASSIFIED SECTION

Pat.: patents.livewell.bayer.com

Bayer, the Bayer Cross, Claritin and the Claritin Vista are registered trademarks of Bayer.

Whippany, NJ 07981

LIQUI-GELS is a registered trademark of Catalent Pharma Colutions, Inc.

PRINCIPAL DISPLAY PANEL - 30 Capsule Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Non-Drowsy*

Claritin ^®

Liqui-Gels^®

24

Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

loratadine 10 mg/antihistamine

Indoor & Outdoor Allergies

Allergies

*When taken as directed.

See Drug Facts Panel.

30 LIQUID-FILLED

CAPSULES

Claritin Carton

30 Count DFL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Claritin DFL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
836338	Claritin Liqui-Gels 10 MG 24HR Oral Capsule	PSN	13
828269	loratadine 10 MG 24HR Oral Capsule	PSN	13
836338	loratadine 10 MG Oral Capsule [Claritin]	SBD	13
828269	loratadine 10 MG Oral Capsule	SCD	13
836338	Claritin 10 MG Oral Capsule	SY	13
828269	loratadine 10 MG 24HR Oral Capsule	SY	13

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0041100807984	GTIN-13: 0041100807984 EAN-13: 0041100807984 GTIN-12: 041100807984 UPC-A: 041100807984 GTIN storage (14 digits): 00041100807984	Claritin 24hr LiquiGels 30 Count DFL.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11523-7200-1	2025-07-29	C162847	48780-1	3b156c62-3193-fb37-e063-e6dba90a4e07	Claritin ® Liqui-Gels ®
11523-7200-2	2025-07-29	C162847	48780-1	3b156c62-3193-fb37-e063-e6dba90a4e07	Claritin ® Liqui-Gels ®
11523-7200-3	2025-07-29	C162847	48780-1	3b156c62-3193-fb37-e063-e6dba90a4e07	Claritin ® Liqui-Gels ®
11523-7200-4	2025-07-29	C162847	48780-1	3b156c62-3193-fb37-e063-e6dba90a4e07	Claritin ® Liqui-Gels ®
11523-7200-5	2025-07-29	C162847	48780-1	3b156c62-3193-fb37-e063-e6dba90a4e07	Claritin ® Liqui-Gels ®
11523-7200-6	2025-07-29	C162847	48780-1	3b156c62-3193-fb37-e063-e6dba90a4e07	Claritin ® Liqui-Gels ®
11523-7200-7	2025-07-29	C162847	48780-1	3b156c62-3193-fb37-e063-e6dba90a4e07	Claritin ® Liqui-Gels ®
11523-7200-8	2025-07-29	C162847	48780-1	3b156c62-3193-fb37-e063-e6dba90a4e07	Claritin ® Liqui-Gels ®
11523-7200-9	2025-07-29	C162847	48780-1	3b156c62-3193-fb37-e063-e6dba90a4e07	Claritin ® Liqui-Gels ®
11523-7333-1	2025-07-29	C162847	48780-1	3b156c62-3193-fb37-e063-e6dba90a4e07	Claritin ® Liqui-Gels ®
11523-7333-3	2025-07-29	C162847	48780-1	3b156c62-3193-fb37-e063-e6dba90a4e07	Claritin ® Liqui-Gels ®
11523-7333-4	2025-07-29	C162847	48780-1	3b156c62-3193-fb37-e063-e6dba90a4e07	Claritin ® Liqui-Gels ®
11523-7333-5	2025-07-29	C162847	48780-1	3b156c62-3193-fb37-e063-e6dba90a4e07	Claritin ® Liqui-Gels ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-7200-1	ClaritinLiqui-Gels	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	13
11523-7200-1	ClaritinLiqui-Gels	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	13
11523-7200-2	ClaritinLiqui-Gels	8 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	8	13
11523-7200-2	ClaritinLiqui-Gels	3 in 1 CARTON	CAPSULE, LIQUID FILLED	3	13
11523-7200-3	ClaritinLiqui-Gels	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	13
11523-7200-3	ClaritinLiqui-Gels	4 in 1 CARTON	CAPSULE, LIQUID FILLED	4	13
11523-7200-4	ClaritinLiqui-Gels	7 in 1 CARTON	CAPSULE, LIQUID FILLED	7	13
11523-7200-4	ClaritinLiqui-Gels	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	13
11523-7200-5	ClaritinLiqui-Gels	1 in 1 POUCH	CAPSULE, LIQUID FILLED	1	13
11523-7200-6	ClaritinLiqui-Gels	3 in 1 CARTON	CAPSULE, LIQUID FILLED	3	13
11523-7200-6	ClaritinLiqui-Gels	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	13
11523-7200-7	ClaritinLiqui-Gels	5 in 1 CARTON	CAPSULE, LIQUID FILLED	5	13
11523-7200-7	ClaritinLiqui-Gels	9 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	9	13
11523-7200-8	ClaritinLiqui-Gels	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	13
11523-7200-8	ClaritinLiqui-Gels	4 in 1 CARTON	CAPSULE, LIQUID FILLED	4	13
11523-7200-9	ClaritinLiqui-Gels	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	13
11523-7200-9	ClaritinLiqui-Gels	6 in 1 CARTON	CAPSULE, LIQUID FILLED	6	13
11523-7333-1	ClaritinLiqui-Gels	5 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	5	13
11523-7333-1	ClaritinLiqui-Gels	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	13
11523-7333-3	ClaritinLiqui-Gels	9 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	9	13
11523-7333-3	ClaritinLiqui-Gels	4 in 1 CARTON	CAPSULE, LIQUID FILLED	4	13
11523-7333-4	ClaritinLiqui-Gels	7 in 1 CARTON	CAPSULE, LIQUID FILLED	7	13
11523-7333-4	ClaritinLiqui-Gels	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	13
11523-7333-5	ClaritinLiqui-Gels	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	13
11523-7333-5	ClaritinLiqui-Gels	10 in 1 CARTON	CAPSULE, LIQUID FILLED	10	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-7200-1	EA - Each	11523-7200	aadf47aa-87c1-425b-a7f6-67866160edcb	1	2013-02-13
11523-7200-2	EA - Each	11523-7200	7facd762-a51d-45fa-94f1-ce08487f429c	1	2013-02-13
11523-7200-3	EA - Each	11523-7200	76a5d6cf-4345-48d9-8064-dfa7d481a898	1	2013-02-13
11523-7200-6	EA - Each	11523-7200	bae274e3-4d2c-4f8a-b379-0ac97ba5a8cd	1	2015-03-03
11523-7200-7	EA - Each	11523-7200	c435ae2a-e01a-4fc3-89c0-5b1f9b83e231	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Loratadine	ACTIVE INGREDIENT	7AJO3BO7QN	3
Loratadine	ACTIVE MOIETY	7AJO3BO7QN	3
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	3
gelatin	INACTIVE INGREDIENT	2G86QN327L	3
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	3
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	3
povidones	INACTIVE INGREDIENT	FZ989GH94E	3
sorbitol	INACTIVE INGREDIENT	506T60A25R	3
water	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Claritin Liqui-Gels
Loratadine
GELATIN
GLYCERIN
POLYSORBATE 80
POVIDONE
WATER
SORBITOL
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-7200	11523-7200-1, 11523-7200-2, 11523-7200-3, 11523-7200-5, 11523-7200-4, 11523-7200-6, 11523-7200-7, 11523-7200-8, 11523-7200-9
11523-7333	11523-7333-1, 11523-7333-3, 11523-7333-4, 11523-7333-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POVIDONE	FZ989GH94E	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
LORATADINE	7AJO3BO7QN	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	IACT
LORATADINE	7AJO3BO7QN	ACTIB
GLYCERIN	PDC6A3C0OX	IACT
POVIDONE	FZ989GH94E	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
GELATIN	2G86QN327L	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 308 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	CAPSULE, EXTENDED RELEASE / ORAL		56 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET, CHEWABLE / ORAL		24 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET / PERIODONTAL	3.44 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	INJECTION, SOLUTION / INTRAVENOUS		4050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	CAPSULE, COATED / ORAL		288 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, LIQUID FILLED / ORAL		24 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET, ORALLY DISINTEGRATING / ORAL	15.03 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	PASTILLE / ORAL	143 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	CAPSULE / ORAL		10932 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	POWDER / ORAL	100 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	INJECTION / INTRACAVITARY	0.05 ml		Exact identifier — unii candidate 44 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, COATED / ORAL		18 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRASYNOVIAL	0.2 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		4739 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	INJECTION, SUSPENSION / INTRAMUSCULAR	1.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	SOLUTION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET, FILM COATED / ORAL		57 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / RECTAL	0.01 %w/v		Exact identifier — unii candidate 37 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	POWDER, FOR SUSPENSION / ORAL	35 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET / ORAL		46 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		5 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	SUSPENSION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	SOLUTION / ORAL		3000 mg	Exact identifier — unii candidate 30 equally ranked IID candidates

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 43.

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
N021952-001	CLARITIN	LORATADINE	10MG	CAPSULE / ORAL		RLD, RS	2008-06-16

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
4a2b0359-b6f2-ddf9-e063-6294a90aed99			8e14b61f-faf6-43a8-a080-75f64514217a	2026-02-06	Warnings	Exact identifier spl id: 4a2b0359-b6f2-ddf9-e063-6294a90aed99 spl set id: 8e14b61f-faf6-43a8-a080-75f64514217a

Reported adverse events (FAERS/openFDA)#

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