FDA.reportPublic FDA data

Claritin

Product NDC
11523-4330
11-digit product format
115234330
Labeler code
11523
Product ID
11523-4330_45370735-3f9c-a7f8-e063-6294a90aa0c6
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA021891
Marketing category
NDA
Marketing start
2015-09-25
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
20938e05-bc3e-51aa-e054-00144ff88e88Available 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
11523-4330-1Claritin1 in 1 CARTONTABLET, CHEWABLE18
11523-4330-1Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE108
11523-4330-3Claritin3 in 1 CARTONTABLET, CHEWABLE38
11523-4330-3Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE108
11523-4330-4Claritin4 in 1 CARTONTABLET, CHEWABLE48
11523-4330-4Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4330-1EA - Each11523-433093078d7d-91a2-4f15-9d81-ac0927cae62412019-01-24
11523-4330-3EA - Each11523-4330bd6f7514-86e5-4922-bbc2-bc60a35caf2a12022-11-07
11523-4330-4EA - Each11523-43307d69a0d5-5c6d-4592-8061-99b8d46374f012022-11-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNCLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC]1
LORATADINEACTIVE MOIETY7AJO3BO7QNCLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4330CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]7Current NDC, Legacy NDC, 6 package rows20221015_20938e05-bc3e-51aa-e054-00144ff88e88.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
ClaritinLORATADINEBayer HealthCare LLC.20938e05-bc3e-51aa-e054-00144ff88e882025-12-05Exact identifier
application applno (NDA): 021891
application number: NDA021891
ndc (product): 11523-4330
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 TabletPSN20938e05-bc3e-51aa-e054-00144ff88e888
665078loratadine 5 MG 24HR Chewable TabletPSN20938e05-bc3e-51aa-e054-00144ff88e888
668469loratadine 5 MG Chewable Tablet [Claritin]SBD20938e05-bc3e-51aa-e054-00144ff88e888
665078loratadine 5 MG Chewable TabletSCD20938e05-bc3e-51aa-e054-00144ff88e888
668469Claritin 5 MG Chewable TabletSY20938e05-bc3e-51aa-e054-00144ff88e888
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
11523-4330-1115234330011 BLISTER PACK in 1 CARTON (11523-4330-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2015-09-250000-00-00NoNoCurrent
11523-4330-3115234330033 BLISTER PACK in 1 CARTON (11523-4330-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2015-09-250000-00-00NoNoCurrent
11523-4330-4115234330044 BLISTER PACK in 1 CARTON (11523-4330-4) / 10 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2015-09-250000-00-00NoNoCurrent