FDA.reportPublic FDA data

CareOne Allergy Relief

Product NDC
41520-612
11-digit product format
415200612
Labeler code
41520
Product ID
41520-612_018a3e2f-e1c3-4fc9-82e5-0bde04555116
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
American Sales Company
Application
ANDA076301
Marketing category
ANDA
Marketing start
2006-06-02
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41520-61241520-612-03DDiscontinued by firm2026-08-03
excluded packagepackage41520-61241520-612-58DDiscontinued by firm2026-08-03
excluded packagepackage41520-61241520-612-60DDiscontinued by firm2026-08-03
excluded packagepackage41520-61241520-612-72DDiscontinued by firm2026-08-03
excluded packagepackage41520-61241520-612-76DDiscontinued by firm2026-08-03
excluded packagepackage41520-61241520-612-95DDiscontinued by firm2026-08-03

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0541520-612-72d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0541520-612-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2641520-612-72f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2641520-612-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3141520-612-722ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3141520-612-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2841520-612-72a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2841520-612-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2141520-612-72cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2141520-612-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1041520-612-72cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1041520-612-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3141520-612-72302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3141520-612-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2041520-612-72ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2041520-612-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1041520-612-720efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1041520-612-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0841520-612-72ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0841520-612-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0341520-612-72367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0341520-612-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0941520-612-72557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0941520-612-60557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076301-001LORATADINELORATADINE10MGTABLET / ORAL2004-06-25

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076301-001LORATADINE10MGTABLET / ORAL2004-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076301-001LORATADINE10MGTABLET / ORAL2004-06-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076301-001LORATADINE10MGTABLET / ORAL2004-06-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076301-001LORATADINE10MGTABLET / ORAL2004-06-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-253f01610625f2…
2019-09-15 20:21 UTC2019-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076301-001LORATADINE10MGTABLET / ORAL2004-06-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A076301-001LORATADINE10MGTABLET / ORAL2004-06-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076301-001LORATADINE10MGTABLET / ORAL2004-06-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
CareOne Allergy Relief
Brand name suffix
24 Hour
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311372Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bbd5424f-fa5b-4955-8542-7011b19400eaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-612-03CareOne Allergy Relief24 Hour70 in 1 BOTTLETABLET7012
41520-612-03CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-46CareOne Allergy Relief24 Hour1 in 1 BLISTER PACKTABLET112
41520-612-46CareOne Allergy Relief24 Hour10 in 1 CARTONTABLET1012
41520-612-58CareOne Allergy Relief24 Hour40 in 1 BOTTLETABLET4012
41520-612-58CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-60CareOne Allergy Relief24 Hour20 in 1 CARTONTABLET2012
41520-612-60CareOne Allergy Relief24 Hour1 in 1 BLISTER PACKTABLET112
41520-612-65CareOne Allergy Relief24 Hour30 in 1 BOTTLETABLET3012
41520-612-65CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-72CareOne Allergy Relief24 Hour60 in 1 BOTTLETABLET6012
41520-612-72CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-75CareOne Allergy Relief24 Hour90 in 1 BOTTLETABLET9012
41520-612-75CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-76CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-76CareOne Allergy Relief24 Hour120 in 1 BOTTLETABLET12012
41520-612-78CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-78CareOne Allergy Relief24 Hour100 in 1 BOTTLETABLET10012
41520-612-82CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-82CareOne Allergy Relief24 Hour200 in 1 BOTTLETABLET20012
41520-612-95CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-95CareOne Allergy Relief24 Hour45 in 1 BOTTLETABLET4512

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNCAREONE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [AMERICAN SALES COMPANY]6
LORATADINEACTIVE MOIETY7AJO3BO7QNCAREONE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [AMERICAN SALES COMPANY]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCAREONE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [AMERICAN SALES COMPANY]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CAREONE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [AMERICAN SALES COMPANY]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ECAREONE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [AMERICAN SALES COMPANY]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-612CAREONE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [AMERICAN SALES COMPANY]10Current NDC, Legacy NDC, 22 package rows20200319_bbd5424f-fa5b-4955-8542-7011b19400ea.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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
allergy reliefLORATADINEWalgreen Company41f8fc1d-2d14-48da-a233-23e9c11296d92026-07-23WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
dg health allergy reliefLORATADINEDolgencorp Incdfc4b065-1980-48ec-9c3e-aaa4a42214d32026-07-02WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
CareOne Allergy Relief 24 HourLORATADINEAmerican Sales Companybbd5424f-fa5b-4955-8542-7011b19400ea2026-07-01WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
ndc (product): 41520-612
allergy reliefLORATADINERite Aid Corporation5d58ed7a-e40b-417f-a216-5ec6721d361b2026-05-27WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
good sense allergy reliefLORATADINEL. Perrigo Company80e8a6e8-0c5f-4065-9545-112e146d25ee2026-04-27WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINEPD-Rx Pharmaceuticals, Inc.039f144b-891b-4ab0-e063-6394a90aa4c82026-02-26WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINEPD-Rx Pharmaceuticals, Inc.775885f9-0580-4eca-94d8-44fce1dcdccd2026-02-26WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
allergy reliefLORATADINECVS Pharmacy0038bc38-c205-4d8d-ab78-1abbcd76829e2026-02-25WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Berkley and Jensen Allergy ReliefLORATADINEBJWCe981a0ef-08e9-4ac3-92a1-411217e0a2512026-02-16WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
LoratadineLORATADINEMajor Pharmaceuticals60162446-4fa1-4ee3-ae20-19fadc2491ab2026-02-09WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Allergy ReliefLORATADINEKroger Companydac0b200-6b02-4c8a-b1dd-a4d5341dfb2d2026-02-05WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Allergy ReliefLORATADINEHyVee Incb6ee2b7f-8e01-4962-b28f-91e5cac852762026-01-28WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINENCS HealthCare of KY, LLC dba Vangard Labsf3d05276-21bd-419d-8dba-07ce278d33752025-12-22WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
LoratadineLORATADINEMajor Pharmaceuticalsdee25423-377b-4b94-a4a8-0dfb8f51aaab2025-12-08WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINEA-S Medication Solutions1203981a-becd-4854-810d-b6d8842b5bd22025-12-06WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
goodnow allergy reliefLORATADINEGobrands, Inc352a1268-7f44-417d-a46a-f0cc2e944a262025-11-15WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
LoratadineLORATADINEA-S Medication Solutions0eade963-be64-4718-a370-7e78efb91fc42025-11-06WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
LoratadineLORATADINEA-S Medication Solutions6f82e0ab-2c01-4afb-8d0f-b0c06819d1b02025-11-06WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
LoratadineLORATADINEA-S Medication Solutions4cee60b6-b32b-47d0-aa00-a7ea1a7ed3cf2025-11-06WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINEPadagis Israel Pharmaceuticals Ltdc72d8a30-520e-4d25-8f02-0c891e070a1a2025-09-12WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNbbd5424f-fa5b-4955-8542-7011b19400ea12
311372loratadine 10 MG Oral TabletSCDbbd5424f-fa5b-4955-8542-7011b19400ea12
311372loratadine 10 MG 24 HR Oral TabletSYbbd5424f-fa5b-4955-8542-7011b19400ea12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-612-03415200612031 BOTTLE in 1 CARTON (41520-612-03) / 70 TABLET in 1 BOTTLE1 bottle2014-08-290000-00-00NoNoCurrent
41520-612-464152006124610 BLISTER PACK in 1 CARTON (41520-612-46) / 1 TABLET in 1 BLISTER PACK10 blister pack2006-06-020000-00-00NoNoCurrent
41520-612-58415200612581 BOTTLE in 1 CARTON (41520-612-58) > 40 TABLET in 1 BOTTLE1 bottle2020-02-250000-00-00NoNoCurrent
41520-612-604152006126020 in 1 CARTONHistorical
41520-612-65415200612651 BOTTLE in 1 CARTON (41520-612-65) / 30 TABLET in 1 BOTTLE1 bottle2007-03-280000-00-00NoNoCurrent
41520-612-724152006127260 in 1 BOTTLEHistorical
41520-612-75415200612751 BOTTLE in 1 CARTON (41520-612-75) / 90 TABLET in 1 BOTTLE1 bottle2006-06-270000-00-00NoNoCurrent
41520-612-76415200612761 BOTTLE in 1 CARTON (41520-612-76) > 120 TABLET in 1 BOTTLE1 bottle2007-02-270000-00-00NoNoCurrent
41520-612-78415200612781 BOTTLE in 1 CARTON (41520-612-78) / 100 TABLET in 1 BOTTLE1 bottle2025-08-01NoNoCurrent
41520-612-82415200612821 BOTTLE in 1 CARTON (41520-612-82) / 200 TABLET in 1 BOTTLE1 bottle2014-02-250000-00-00NoNoCurrent
41520-612-95415200612951 BOTTLE in 1 CARTON (41520-612-95) > 45 TABLET in 1 BOTTLE1 bottle2014-10-130000-00-00NoNoCurrent