FDA.reportPublic FDA data

Claritin

Product NDC
11523-4331
11-digit product format
115234331
Labeler code
11523
Product ID
11523-4331_453703bf-d4b7-d090-e063-6394a90a7ebf
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA021891
Marketing category
NDA
Marketing start
2006-08-23
Substance
LORATADINE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021891-001CHILDREN'S CLARITINLORATADINE5MGTABLET, CHEWABLE / ORALRLD2006-08-23
N021891-002CLARITINLORATADINE10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-21

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD2006-08-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD, RS2018-11-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD, RS2006-08-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD2018-11-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD, RS2006-08-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD2018-11-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD, RS2006-08-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD2018-11-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD, RS2006-08-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD2018-11-21bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Claritin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7AJO3BO7QNInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
665078Internal RxNorm lookup
668469Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
37732ca2-b454-4215-91a2-c62e0f7a56afAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4331-1Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4331-1Claritin4 in 1 CARTONTABLET, CHEWABLE414
11523-4331-2Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014
11523-4331-2Claritin6 in 1 CARTONTABLET, CHEWABLE614
11523-4331-6Claritin8 in 1 CARTONTABLET, CHEWABLE814
11523-4331-6Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
aspartameINACTIVE INGREDIENTZ0H242BBR1CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
D&C red No. 27INACTIVE INGREDIENT2LRS185U6KCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
mannitolINACTIVE INGREDIENT3OWL53L36ACLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2CLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APCLARITIN (LORATADINE) TABLET, CHEWABLE [MSD CONSUMER CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4331CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]13Current NDC, Legacy NDC, 6 package rows20230629_37732ca2-b454-4215-91a2-c62e0f7a56af.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClaritinLORATADINEBayer HealthCare LLC.37732ca2-b454-4215-91a2-c62e0f7a56af2025-12-05WarningsExact identifier
application applno (NDA): 021891
application number: NDA021891
ndc (product): 11523-4331
ClaritinLORATADINEBayer HealthCare LLC.20938e05-bc3e-51aa-e054-00144ff88e882025-12-05Exact identifier
application applno (NDA): 021891
application number: NDA021891
Claritin Chewable Cool Mint FlavorLORATADINEBayer HealthCare LLC.98b99bb9-d499-9ab4-e053-2a95a90a6ae62025-12-05WarningsExact identifier
application applno (NDA): 021891
application number: NDA021891
Claritin Chewable Grape and BubblegumLORATADINEBayer HealthCare LLC.0371368b-dca6-af2f-e063-6394a90a0ac02025-12-04WarningsExact identifier
application applno (NDA): 021891
application number: NDA021891

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668469Claritin Children's 5 MG 24HR Chewable TabletPSN37732ca2-b454-4215-91a2-c62e0f7a56af14
665078loratadine 5 MG 24HR Chewable TabletPSN37732ca2-b454-4215-91a2-c62e0f7a56af14
668469loratadine 5 MG Chewable Tablet [Claritin]SBD37732ca2-b454-4215-91a2-c62e0f7a56af14
665078loratadine 5 MG Chewable TabletSCD37732ca2-b454-4215-91a2-c62e0f7a56af14
668469Claritin 5 MG Chewable TabletSY37732ca2-b454-4215-91a2-c62e0f7a56af14
668469Claritin Children's 5 MG 24HR Chewable TabletPSN0371368b-dca6-af2f-e063-6394a90a0ac02
665078loratadine 5 MG 24HR Chewable TabletPSN0371368b-dca6-af2f-e063-6394a90a0ac02
668469loratadine 5 MG Chewable Tablet [Claritin]SBD0371368b-dca6-af2f-e063-6394a90a0ac02
665078loratadine 5 MG Chewable TabletSCD0371368b-dca6-af2f-e063-6394a90a0ac02
668469Claritin 5 MG Chewable TabletSY0371368b-dca6-af2f-e063-6394a90a0ac02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-4331-1115234331014 BLISTER PACK in 1 CARTON (11523-4331-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2006-08-230000-00-00NoNoCurrent
11523-4331-2115234331026 BLISTER PACK in 1 CARTON (11523-4331-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACK6 blister pack2019-09-060000-00-00NoNoCurrent
11523-4331-6115234331068 BLISTER PACK in 1 CARTON (11523-4331-6) / 10 TABLET, CHEWABLE in 1 BLISTER PACK8 blister pack2006-08-23NoNoCurrent