FDA.reportPublic FDA data

Application 021891

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S CLARITINLORATADINETABLET, CHEWABLE;ORAL5MGYesYes
002CLARITINLORATADINETABLET, CHEWABLE;ORAL10MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2021-12-28 21:50 UTC2021-12N021891-001CHILDREN'S CLARITIN5MGTABLET, CHEWABLE / ORALRLD, RS2006-08-23782e0a99824c…
2021-12-28 21:50 UTC2021-12N021891-002CLARITIN10MGTABLET, CHEWABLE / ORALRLD2018-11-21782e0a99824c…

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
ndc (product): 11523-4328
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
ndc (product): 11523-4364
Claritin Chewable Grape and BubblegumLORATADINEBayer HealthCare LLC.0371368b-dca6-af2f-e063-6394a90a0ac02025-12-04WarningsExact identifier
application applno (NDA): 021891
application number: NDA021891

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11523-4328ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4328ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4328ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4328ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4328ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4328ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4330ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-4330ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-4330ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-4331ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4331ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4331ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4331ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4331ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4331ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4364Claritin ChewableloratadineBayer HealthCare LLC.NDACurrent
11523-4364Claritin ChewableloratadineBayer HealthCare LLC.NDACurrent
11523-4364Claritin ChewableloratadineBayer HealthCare LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
86010SUPPL 2026-05-21
86006SUPPL 2026-05-21
85768SUPPL 2026-04-27
85761SUPPL 2026-04-27
82297SUPPL 2025-05-23
82103SUPPL 2025-05-01
82021SUPPL 2025-04-28
79692SUPPL 2024-09-23
79691SUPPL 2024-09-23
73070SUPPL2023-01-03
73059SUPPL2022-12-28
68142SUPPL2021-07-21
67210SUPPL2021-04-28
66991SUPPL2021-04-06
66479SUPPL2021-03-04
65870SUPPL2021-01-08
64244SUPPL2020-08-10
61234SUPPL2019-12-11
61233SUPPL2019-12-11
60247SUPPL2019-10-07
60246SUPPL2019-10-07
59109SUPPL2019-06-18
59108SUPPL2019-06-18
57121SUPPL2019-01-04
57118SUPPL2019-01-04
57053SUPPL2018-12-30
56723SUPPL2018-12-12
55110SUPPL2018-08-03
54945SUPPL2018-07-23
53020SUPPL2018-03-15
52696SUPPL2018-02-23
48536SUPPL2017-05-25
48524SUPPL2017-05-25
16527SUPPL2016-04-11
6396SUPPL2016-04-07
16526SUPPL2016-02-11
6395SUPPL2015-12-29
37833SUPPL2014-07-29
6394SUPPL2014-07-28
6393SUPPL2010-06-29
6392SUPPL2008-10-23
28790SUPPL2008-10-09
42340ORIG2008-07-09
28789ORIG2006-09-18
37832ORIG2006-09-15