Claritin

Manufacturer: Bayer HealthCare LLC. | Patheon Manufacturing Services LLC
Effective date: 2025-12-05
Label type: HUMAN OTC DRUG LABEL
Version: 14
Source: full-release
Hydrated at: 2026-06-01 01:20:15

Label at a glance#

ProductClaritin

Active ingredientLORATADINE

Label structure10 sections

Indications and uses

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

Dosage and administration

adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

phenylketonurics: contains phenylalanine 1.4 mg per tablet safety sealed: do not use if the individual blister unit imprinted with Children's Claritin® is open or torn store between 20° to 25°C (68° to 77°F)

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 5 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
sneezing
itchy, watery eyes
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	chew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of age	chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

STORAGE AND HANDLING SECTION

phenylketonurics: contains phenylalanine 1.4 mg per tablet
safety sealed: do not use if the individual blister unit imprinted with Children's Claritin® is open or torn
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Dist by: Bayer HealthCare LLC, Whippany, NJ 07981

Product of Ireland

PRINCIPAL DISPLAY PANEL - 10 Chewable Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11523-4328-1

ages

2 years

and older

Children's

Claritin^®

Allergy

loratadine 5 mg/antihistamine

Indoor & Outdoor

Allergies

Non-Drowsy*

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

10 CHEWABLE TABLETS

Grape

Flavored

Chewables

*When taken as directed. See Drug Facts Panel.

Carton

Carton 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
668469	Claritin Children's 5 MG 24HR Chewable Tablet	PSN	14
665078	loratadine 5 MG 24HR Chewable Tablet	PSN	14
668469	loratadine 5 MG Chewable Tablet [Claritin]	SBD	14
665078	loratadine 5 MG Chewable Tablet	SCD	14
668469	Claritin 5 MG Chewable Tablet	SY	14

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0041100810748	GTIN-13: 0041100810748 EAN-13: 0041100810748 GTIN-12: 041100810748 UPC-A: 041100810748 GTIN storage (14 digits): 00041100810748	Cropped 2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-4328-1	Claritin	1 in 1 CARTON	TABLET, CHEWABLE	1	14
11523-4328-1	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	14
11523-4328-2	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	14
11523-4328-2	Claritin	2 in 1 CARTON	TABLET, CHEWABLE	2	14
11523-4328-3	Claritin	3 in 1 CARTON	TABLET, CHEWABLE	3	14
11523-4328-3	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	14
11523-4328-4	Claritin	2 in 1 BLISTER PACK	TABLET, CHEWABLE	2	14
11523-4328-4	Claritin	1 in 1 POUCH	TABLET, CHEWABLE	1	14
11523-4328-5	Claritin	5 in 1 CARTON	TABLET, CHEWABLE	5	14
11523-4328-5	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	14
11523-4328-6	Claritin	2 in 1 POUCH	TABLET, CHEWABLE	2	14
11523-4328-6	Claritin	50 in 1 BOX	TABLET, CHEWABLE	50	14
11523-4328-7	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	14
11523-4328-7	Claritin	2.5 in 1 PACKAGE, COMBINATION	TABLET, CHEWABLE	2.5	14
11523-4328-9	Claritin	4 in 1 CARTON	TABLET, CHEWABLE	4	14
11523-4328-9	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	14
11523-4331-1	Claritin	4 in 1 CARTON	TABLET, CHEWABLE	4	14
11523-4331-1	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	14
11523-4331-2	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	14
11523-4331-2	Claritin	6 in 1 CARTON	TABLET, CHEWABLE	6	14
11523-4331-6	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	14
11523-4331-6	Claritin	8 in 1 CARTON	TABLET, CHEWABLE	8	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-4328-1	EA - Each	11523-4328	5114fcbe-6e66-40a3-a5d0-0bf035e03df1	1	2013-08-02
11523-4328-2	EA - Each	11523-4328	86b533c8-7143-4bb8-b69c-c54ff9fa410d	1	2013-08-02
11523-4328-3	EA - Each	11523-4328	529e2357-052f-420a-93c8-e901a203bdda	1	2013-08-02
11523-4328-5	EA - Each	11523-4328	7fe6ee37-c9c5-4b72-aabf-364bc3e08788	1	2015-10-02
11523-4328-7	EA - Each	11523-4328	a605aa3e-7379-4ca1-83ea-42f0100ecbcb	1	2022-06-06
11523-4328-9	EA - Each	11523-4328	9c176afb-b4fb-4f1c-9967-4be854b03b86	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Loratadine	ACTIVE INGREDIENT	7AJO3BO7QN	2
Loratadine	ACTIVE MOIETY	7AJO3BO7QN	2
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	2
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	2
aspartame	INACTIVE INGREDIENT	Z0H242BBR1	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	2
D&C red No. 27	INACTIVE INGREDIENT	2LRS185U6K	2
FD&C blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	2
mannitol	INACTIVE INGREDIENT	3OWL53L36A	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	2

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Claritin
Loratadine
ANHYDROUS CITRIC ACID
SILICON DIOXIDE
D&C RED NO. 27
FD&C BLUE NO. 2
ALUMINUM OXIDE
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
SODIUM STARCH GLYCOLATE TYPE A POTATO
ASPARTAME

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-4328	11523-4328-1, 11523-4328-2, 11523-4328-3, 11523-4328-5, 11523-4328-4, 11523-4328-7, 11523-4328-9, 11523-4328-6
11523-4331	11523-4331-1, 11523-4331-2, 11523-4331-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
D&C RED NO. 27	2LRS185U6K	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
LORATADINE	7AJO3BO7QN	ACTIB
ASPARTAME	Z0H242BBR1	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MANNITOL	3OWL53L36A	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
ASPARTAME	Z0H242BBR1	IACT
LORATADINE	7AJO3BO7QN	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
D&C RED NO. 27	2LRS185U6K	IACT
STEARIC ACID	4ELV7Z65AP	IACT
ALUMINUM OXIDE	LMI26O6933	IACT

Source Document#

Source XML · Source PDF

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 3 · 130 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, CHEWABLE / ORAL		3 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, CHEWABLE / ORAL		3 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
aspartame	ASPARTAME	Z0H242BBR1	TABLET, CHEWABLE / ORAL		195 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
D&C red No. 27	D&C RED NO. 27	2LRS185U6K	TABLET, CHEWABLE / ORAL		7 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, CHEWABLE / ORAL		3 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
D&C red No. 27	D&C RED NO. 27	2LRS185U6K	TABLET, CHEWABLE / ORAL		7 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
aspartame	ASPARTAME	Z0H242BBR1	TABLET, CHEWABLE / ORAL		195 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
aspartame	ASPARTAME	Z0H242BBR1	TABLET, CHEWABLE / ORAL		195 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 13 equally ranked IID candidates
FD&C blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, CHEWABLE / ORAL		3 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
D&C red No. 27	D&C RED NO. 27	2LRS185U6K	TABLET, CHEWABLE / ORAL		7 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, CHEWABLE / ORAL		3 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, CHEWABLE / ORAL		3 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 13 equally ranked IID candidates
D&C red No. 27	D&C RED NO. 27	2LRS185U6K	TABLET, CHEWABLE / ORAL		7 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
aspartame	ASPARTAME	Z0H242BBR1	TABLET, CHEWABLE / ORAL		195 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 13 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 13 equally ranked IID candidates
FD&C blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, CHEWABLE / ORAL		3 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 13 equally ranked IID candidates
FD&C blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, CHEWABLE / ORAL		3 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C blue No. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, CHEWABLE / ORAL		3 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
D&C red No. 27	D&C RED NO. 27	2LRS185U6K	TABLET, CHEWABLE / ORAL		7 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii+route+dosage form 13 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 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
N021891-001	CHILDREN'S CLARITIN	LORATADINE	5MG	TABLET, CHEWABLE / ORAL		RLD	2006-08-23
N021891-002	CLARITIN	LORATADINE	10MG	TABLET, CHEWABLE / ORAL		RLD, RS	2018-11-21

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 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	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Claritin	LORATADINE	Bayer HealthCare LLC.	37732ca2-b454-4215-91a2-c62e0f7a56af	2025-12-05	Warnings	Exact identifier ndc (package): 11523-4328-5 ndc (package): 11523-4328-7 ndc (package): 11523-4331-6 ndc (package): 11523-4328-2 ndc (package): 11523-4328-4 ndc (package): 11523-4331-2 ndc (package): 11523-4328-6 ndc (package): 11523-4328-9 ndc (package): 11523-4331-1 ndc (package): 11523-4328-1 ndc (package): 11523-4328-3 ndc (product): 11523-4331 ndc (product): 11523-4328 ndc11 (package): 11523432802 ndc11 (package): 11523433106 ndc11 (package): 11523432803 ndc11 (package): 11523432805 ndc11 (package): 11523433101 ndc11 (package): 11523432804 ndc11 (package): 11523432801 ndc11 (package): 11523432809 ndc11 (package): 11523432807 ndc11 (package): 11523433102 ndc11 (package): 11523432806 spl id: 453703bf-d4b7-d090-e063-6394a90a7ebf spl set id: 37732ca2-b454-4215-91a2-c62e0f7a56af

Reported adverse events (FAERS/openFDA)#

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