Loratadine Allergy Relief

Product NDC
71141-132
Requested package NDC
71141-132-32
11-digit product format
711410132
Labeler code
71141
Product ID
71141-132_059bf46f-8a79-486a-995f-5f4e986ea178
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
LIDL US, LLC
Application
ANDA076134
Marketing category
ANDA
Marketing start
2017-09-01
Substance
LORATADINE
Active strength
10 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 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
A076134-001LORATADINELORATADINE10MGTABLET / ORAL2003-08-18

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 UTC2026-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076134-001LORATADINE10MGTABLET / ORAL2003-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076134-001LORATADINE10MGTABLET / ORAL2003-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076134-001LORATADINE10MGTABLET / ORAL2003-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-183f01610625f2…
2019-09-15 20:21 UTC2019-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A076134-001LORATADINE10MGTABLET / ORAL2003-08-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine Allergy Relief
Listing expiration
2026-12-31

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
11bc027c-d28d-45f0-a4cb-24a3834a6995Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71141-132-32Loratadine Allergy Relief10 in 1 BLISTER PACKTABLET101
71141-132-32Loratadine Allergy Relief1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71141-132LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [LIDL US, LLC]1Current NDC, Legacy NDC, 2 package rows20180110_11bc027c-d28d-45f0-a4cb-24a3834a6995.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINECardinal Health 107, LLC64489b01-a4a7-4c6d-ac84-1dfbd1388d842026-06-04WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
MEDIQUE LoradamedLORATADINESportpharm LLCd6bf0e68-f87c-49ee-a15d-df7f5bfa62212026-04-24WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEPD-Rx Pharmaceuticals, Inc.7127b39d-3686-4249-b720-43c02b4c46542026-03-19WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEA-S Medication Solutionsa53e5635-8633-4c28-b04f-cdfb3d851e682026-02-19WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Green Guard 24 Hour Allergy ReliefLORATADINEUnifirst First Aid Corporation32092beb-c177-4b6b-afa4-b4b5d64621f42025-11-21WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEMarlex Pharmaceuticals, Inc.ec08a6ee-3d71-0fa9-e053-2995a90a9cb12025-11-18WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
McKesson LoratadineLORATADINE 10 MGMcKesson Medical Surgicalc6a3056e-792e-52a4-e053-2a95a90a83612025-10-23WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEAsclemed USA, Inc.332bda00-1350-2d33-e063-6394a90a8bd72025-05-21WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEA-S Medication Solutions0be70365-57ee-4f2e-a30f-bdd5c292992d2025-02-20WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEA-S Medication Solutionsbaaf9c23-0b54-46a2-8aec-13264479a6d72025-02-20WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
LoratadineLORATADINEAmerican Health Packaging411f3692-99ff-49d7-8594-e6f404f5861f2024-11-21WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEProficient Rx LPa6b9a1bf-1013-4a15-b3b2-a226a75a1ffb2024-10-01WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEBryant Ranch Prepack40914eeb-3a85-4691-9fb8-2df72ba1f7092024-04-05WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEBryant Ranch Prepack94642b79-f91a-429f-87f4-dad326d4f3ed2024-04-03WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEOHM LABORATORIES INC.c35f2cc1-f76d-4824-b0a5-747bca0c3b852023-12-08WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Handy Solutions 24 Hour AllergyLORATADINENavajo Manufacturing Company Inc.67263031-9095-48f2-8b34-e589b28a74162023-03-15WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
LoratadineLORATADINESAFEWAY INC.1092b8af-25f2-4c25-b3bc-5ffb14e960242021-12-21WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
LoratadineLORATADINECVS Pharmacye63f082c-ff50-43ed-ad2c-598b352413e82021-12-21WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEDISCOUNT DRUG MART55d3ee36-116b-4ec6-b409-79d67a2b54ae2018-09-14WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEWinCo Foods, LLC506a60e8-7fec-4bb0-babc-204058ae120f2018-08-29WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN11bc027c-d28d-45f0-a4cb-24a3834a69951
311372loratadine 10 MG Oral TabletSCD11bc027c-d28d-45f0-a4cb-24a3834a69951
311372loratadine 10 MG 24 HR Oral TabletSY11bc027c-d28d-45f0-a4cb-24a3834a69951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71141-132-32711410132321 BLISTER PACK in 1 CARTON (71141-132-32) / 10 TABLET in 1 BLISTER PACK1 blister pack2017-09-010000-00-00NoNoCurrent