Claritin

Product NDC
52904-630
11-digit product format
529040630
Labeler code
52904
Product ID
52904-630_c9fb571f-a54e-442b-adeb-9b6fbc75fea9
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Select Corporation
Application
NDA019658
Marketing category
NDA
Marketing start
2011-12-15
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52904-630IInactivated by FDA2026-08-03
excluded packagepackage52904-63052904-630-03IInactivated by FDA2026-08-03
excluded packagepackage52904-63052904-630-20IInactivated by FDA2026-08-03
excluded packagepackage52904-63052904-630-25IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52904-630-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52904-630-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52904-630-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-630-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-630-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-630-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-630-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-630-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-630-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-630-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-630-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-630-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-630-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-630-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-630-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-630-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-630-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-630-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-630-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-630-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-630-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-630-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-630-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-630-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-630-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-630-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-630-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-630-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-630-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-630-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52904-630-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52904-630-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52904-630-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52904-630-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52904-630-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52904-630-20557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52904-630-038af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52904-630-258af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52904-630-208af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52904-630-03834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52904-630-25834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52904-630-20834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52904-630-031332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52904-630-251332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52904-630-201332a3947898…d4bfe170f9cd…

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
N019658-002CLARITINLORATADINE10MGTABLET / ORALRLD, RS2002-11-27
N019658-003CLARITIN HIVES RELIEFLORATADINE10MGTABLET / ORALRLD, RS2003-11-19

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 UTC2026-02N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019658-002CLARITIN10MGTABLET / ORALRLD, RS2002-11-27782e0a99824c…
2021-12-28 21:50 UTC2021-12N019658-003CLARITIN HIVES RELIEF10MGTABLET / ORALRLD, RS2003-11-19782e0a99824c…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52904-630-032024-01-30C16284748780-11030e365-2b5c-111a-e063-dadaa90a10e2Claritin ®
52904-630-202024-01-30C16284748780-11030e365-2b5c-111a-e063-dadaa90a10e2Claritin ®
52904-630-252024-01-30C16284748780-11030e365-2b5c-111a-e063-dadaa90a10e2Claritin ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-630-03Claritin1 in 1 BLISTER PACKTABLET12
52904-630-03Claritin1 in 1 POUCHTABLET12
52904-630-20Claritin20 in 1 CARTONTABLET202
52904-630-20Claritin1 in 1 POUCHTABLET12
52904-630-25Claritin25 in 1 CARTONTABLET252
52904-630-25Claritin1 in 1 POUCHTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-630CLARITIN (LORATADINE) TABLET [SELECT CORPORATION]2Legacy NDC, 6 package rows20220609_677bf76d-e75d-4212-b1f2-eaaf25b27cb7.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClaritinLORATADINEBayer HealthCare LLC.660ac9df-f1b1-4c89-94dd-9fae0a013f3c2025-12-05WarningsExact identifier
application applno (NDA): 019658
application number: NDA019658
ClaritinLORATADINEBayer HealthCare LLCac32d6f9-f553-4d5c-ad36-575af5ea56de2025-12-04WarningsExact identifier
application applno (NDA): 019658
application number: NDA019658
ClaritinLORATADINER J General Corporationa34e8cb7-4fdf-45be-b288-45d93eef62202025-11-17WarningsExact identifier
application applno (NDA): 019658
application number: NDA019658
Claritin, BSX Non-Drowsy, 24 HourLORATADINELil' Drug Store Products, Incf85b0527-107c-4a4a-aad7-61d2f52bad632023-03-17WarningsExact identifier
application applno (NDA): 019658
application number: NDA019658
ClaritinLORATADINENavajo Manufacturing Company60a5dc14-3f74-8414-e053-2991aa0ad34a2023-03-01WarningsExact identifier
application applno (NDA): 019658
application number: NDA019658
ClaritinLORATADINENavajo Manufacturing Company Inc.219ab9c4-d0c4-4256-ab64-66d0260886bd2023-03-01WarningsExact identifier
application applno (NDA): 019658
application number: NDA019658

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206805Claritin 24HR Allergy 10 MG Oral TabletPSN677bf76d-e75d-4212-b1f2-eaaf25b27cb72
311372loratadine 10 MG 24HR Oral TabletPSN677bf76d-e75d-4212-b1f2-eaaf25b27cb72
206805loratadine 10 MG Oral Tablet [Claritin]SBD677bf76d-e75d-4212-b1f2-eaaf25b27cb72
311372loratadine 10 MG Oral TabletSCD677bf76d-e75d-4212-b1f2-eaaf25b27cb72
206805Claritin 10 MG 24 HR Oral TabletSY677bf76d-e75d-4212-b1f2-eaaf25b27cb72
206805Claritin 10 MG Oral TabletSY677bf76d-e75d-4212-b1f2-eaaf25b27cb72
311372loratadine 10 MG 24 HR Oral TabletSY677bf76d-e75d-4212-b1f2-eaaf25b27cb72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52904-630-03529040630031 POUCH in 1 BLISTER PACK (52904-630-03) > 1 TABLET in 1 POUCH1 pouch2011-12-150000-00-00NoNoCurrent
52904-630-205290406302020 POUCH in 1 CARTON (52904-630-20) > 1 TABLET in 1 POUCH20 pouch2011-12-150000-00-00NoNoCurrent
52904-630-255290406302525 POUCH in 1 CARTON (52904-630-25) > 1 TABLET in 1 POUCH25 pouch2011-12-150000-00-00NoNoCurrent