FDA.reportPublic FDA data

allergy relief

Product NDC
11822-0612
11-digit product format
118220612
Labeler code
11822
Product ID
11822-0612_71e31295-014f-46af-a749-9cee38182a6e
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA076301
Marketing category
ANDA
Marketing start
2004-10-21
Marketing end
2026-12-31
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-061211822-0612-1DDiscontinued by firm2026-08-17
excluded packagepackage11822-061211822-0612-2DDiscontinued by firm2026-08-17
excluded packagepackage11822-061211822-0612-3DDiscontinued by firm2026-08-17
excluded packagepackage11822-061211822-0612-6DDiscontinued by firm2026-08-17

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 · 28 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 2025-12-0511822-0612-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0511822-0612-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0511822-0612-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2611822-0612-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2611822-0612-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2611822-0612-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3111822-0612-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3111822-0612-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3111822-0612-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2811822-0612-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2811822-0612-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2811822-0612-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2111822-0612-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2111822-0612-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2111822-0612-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1011822-0612-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1011822-0612-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1011822-0612-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3111822-0612-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3111822-0612-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3111822-0612-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2011822-0612-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2011822-0612-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2011822-0612-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1011822-0612-60efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0811822-0612-6ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0311822-0612-6367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0911822-0612-6557ba5c1ecfa…9c80585c8c6e…

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

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
allergy relief

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
5d58ed7a-e40b-417f-a216-5ec6721d361bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0612-1allergy relief3 in 1 CARTONTABLET310
11822-0612-1allergy relief10 in 1 BLISTER PACKTABLET1010
11822-0612-2allergy relief10 in 1 BLISTER PACKTABLET1010
11822-0612-2allergy relief1 in 1 CARTONTABLET110
11822-0612-3allergy relief60 in 1 BOTTLETABLET6010
11822-0612-3allergy relief1 in 1 CARTONTABLET110
11822-0612-4allergy relief1 in 1 CARTONTABLET110
11822-0612-4allergy relief120 in 1 BOTTLETABLET12010
11822-0612-5allergy relief1 in 1 CARTONTABLET110
11822-0612-5allergy relief45 in 1 BOTTLETABLET4510
11822-0612-6allergy relief2 in 1 CARTONTABLET210
11822-0612-6allergy relief10 in 1 BLISTER PACKTABLET1010
11822-0612-7allergy relief1 in 1 CARTONTABLET110
11822-0612-7allergy relief300 in 1 BOTTLETABLET30010
11822-0612-8allergy relief1 in 1 CARTONTABLET110
11822-0612-8allergy relief70 in 1 BOTTLETABLET7010
11822-0612-9allergy relief30 in 1 BOTTLETABLET3010
11822-0612-9allergy relief1 in 1 CARTONTABLET110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNALLERGY RELIEF (LORATADINE) TABLET [RITE AID CORPORATION]3
LORATADINEACTIVE MOIETY7AJO3BO7QNALLERGY RELIEF (LORATADINE) TABLET [RITE AID CORPORATION]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLERGY RELIEF (LORATADINE) TABLET [RITE AID CORPORATION]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (LORATADINE) TABLET [RITE AID CORPORATION]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EALLERGY RELIEF (LORATADINE) TABLET [RITE AID CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0612ALLERGY RELIEF (LORATADINE) TABLET [RITE AID CORPORATION]9Current NDC, Legacy NDC, 18 package rows20250112_5d58ed7a-e40b-417f-a216-5ec6721d361b.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
allergy reliefLORATADINERite Aid Corporation5d58ed7a-e40b-417f-a216-5ec6721d361b2026-05-27WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
ndc (product): 11822-0612
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 TabletPSN5d58ed7a-e40b-417f-a216-5ec6721d361b10
311372loratadine 10 MG Oral TabletSCD5d58ed7a-e40b-417f-a216-5ec6721d361b10
311372loratadine 10 MG 24 HR Oral TabletSY5d58ed7a-e40b-417f-a216-5ec6721d361b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0612-11182206120130 BLISTER PACK in 1 CARTON (11822-0612-1) > 1 TABLET in 1 BLISTER PACK30 blister pack2004-11-182021-11-30NoNoCurrent
11822-0612-2118220612021 BLISTER PACK in 1 CARTON (11822-0612-2) / 10 TABLET in 1 BLISTER PACK1 blister pack2004-10-212021-11-30NoNoCurrent
11822-0612-3118220612031 BOTTLE in 1 CARTON (11822-0612-3) > 60 TABLET in 1 BOTTLE1 bottle2005-07-082021-12-31NoNoCurrent
11822-0612-4118220612041 BOTTLE in 1 CARTON (11822-0612-4) / 120 TABLET in 1 BOTTLE1 bottle2005-04-152021-11-30NoNoCurrent
11822-0612-5118220612051 BOTTLE in 1 CARTON (11822-0612-5) / 45 TABLET in 1 BOTTLE1 bottle2014-01-232026-12-31NoNoHistorical
11822-0612-61182206120620 BLISTER PACK in 1 CARTON (11822-0612-6) > 1 TABLET in 1 BLISTER PACK20 blister pack2020-05-190000-00-00NoNoCurrent
11822-0612-7118220612071 BOTTLE in 1 CARTON (11822-0612-7) / 300 TABLET in 1 BOTTLE1 bottle2020-05-190000-00-00NoNoCurrent
11822-0612-8118220612081 BOTTLE in 1 CARTON (11822-0612-8) / 70 TABLET in 1 BOTTLE1 bottle2023-04-252026-12-31NoNoHistorical
11822-0612-9118220612091 BOTTLE in 1 CARTON (11822-0612-9) / 30 TABLET in 1 BOTTLE1 bottle2023-06-142026-12-31NoNoHistorical