Loratadine Allergy Relief

Product NDC
51660-526
Requested package NDC
51660-526-03
11-digit product format
516600526
Labeler code
51660
Product ID
51660-526_ab379305-5823-49e9-89ca-641c1d37a6f3
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
OHM LABORATORIES INC.
Application
ANDA076134
Marketing category
ANDA
Marketing start
2017-11-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage51660-52651660-526-03UNFINISHEDActive or certified unfinished drug listing2026-08-03

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 · 8 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…

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
c35f2cc1-f76d-4824-b0a5-747bca0c3b85Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-526-01Loratadine Allergy Relief100 in 1 BOTTLETABLET10010
51660-526-05Loratadine Allergy Relief500 in 1 BOTTLETABLET50010
51660-526-11Loratadine Allergy Relief10 in 1 BLISTER PACKTABLET1010
51660-526-30Loratadine Allergy Relief30 in 1 BOTTLETABLET3010
51660-526-31Loratadine Allergy Relief30 in 1 BLISTER PACKTABLET3010
51660-526-53Loratadine Allergy Relief300 in 1 BOTTLETABLET30010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-526-01EA - Each51660-52623ef566a-7fbc-42f3-aa01-eac9d9a2b12012012-07-24
51660-526-05EA - Each51660-52682cd5b39-27fb-4a5f-8caa-efa85266448a12012-07-24
51660-526-30EA - Each51660-526bd00fc2c-7bf3-47f5-a7cd-7aeaec6fdddb12019-10-07
51660-526-31EA - Each51660-5262d65982b-8238-4b58-a5c6-9732389e460712012-07-24
51660-526-53EA - Each51660-52616eb7af6-5422-4617-aafa-52f14555717f12018-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [MAJOR PHARMACEUTICALS]18
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [MAJOR PHARMACEUTICALS]18
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [MAJOR PHARMACEUTICALS]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [MAJOR PHARMACEUTICALS]18
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [MAJOR PHARMACEUTICALS]18
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE ALLERGY RELIEF (LORATADINE) TABLET [OHM LABORATORIES INC.]3
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE ALLERGY RELIEF (LORATADINE) TABLET [OHM LABORATORIES INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE ALLERGY RELIEF (LORATADINE) TABLET [OHM LABORATORIES INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [OHM LABORATORIES INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE ALLERGY RELIEF (LORATADINE) TABLET [OHM LABORATORIES INC.]3
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [REBEL DISTRIBUTORS CORP]2
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [AMERICAN HEALTH PACKAGING]2
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [AMERICAN HEALTH PACKAGING]2
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [REBEL DISTRIBUTORS CORP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-526LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [OHM LABORATORIES INC.]10Current NDC, Legacy NDC, 6 package rows20231216_c35f2cc1-f76d-4824-b0a5-747bca0c3b85.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
ndc (product): 51660-526
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 TabletPSN7127b39d-3686-4249-b720-43c02b4c465419
311372loratadine 10 MG Oral TabletSCD7127b39d-3686-4249-b720-43c02b4c465419
311372loratadine 10 MG 24 HR Oral TabletSY7127b39d-3686-4249-b720-43c02b4c465419
311372loratadine 10 MG 24HR Oral TabletPSNa53e5635-8633-4c28-b04f-cdfb3d851e6813
311372loratadine 10 MG Oral TabletSCDa53e5635-8633-4c28-b04f-cdfb3d851e6813
311372loratadine 10 MG 24 HR Oral TabletSYa53e5635-8633-4c28-b04f-cdfb3d851e6813
311372loratadine 10 MG 24HR Oral TabletPSNc35f2cc1-f76d-4824-b0a5-747bca0c3b8510
311372loratadine 10 MG Oral TabletSCDc35f2cc1-f76d-4824-b0a5-747bca0c3b8510
311372loratadine 10 MG 24 HR Oral TabletSYc35f2cc1-f76d-4824-b0a5-747bca0c3b8510
311372loratadine 10 MG 24HR Oral TabletPSN411f3692-99ff-49d7-8594-e6f404f5861f8
311372loratadine 10 MG Oral TabletSCD411f3692-99ff-49d7-8594-e6f404f5861f8
311372loratadine 10 MG 24 HR Oral TabletSY411f3692-99ff-49d7-8594-e6f404f5861f8
311372loratadine 10 MG 24HR Oral TabletPSNa6b9a1bf-1013-4a15-b3b2-a226a75a1ffb6
311372loratadine 10 MG 24HR Oral TabletPSN94642b79-f91a-429f-87f4-dad326d4f3ed6
311372loratadine 10 MG Oral TabletSCDa6b9a1bf-1013-4a15-b3b2-a226a75a1ffb6
311372loratadine 10 MG Oral TabletSCD94642b79-f91a-429f-87f4-dad326d4f3ed6
311372loratadine 10 MG 24 HR Oral TabletSYa6b9a1bf-1013-4a15-b3b2-a226a75a1ffb6
311372loratadine 10 MG 24 HR Oral TabletSY94642b79-f91a-429f-87f4-dad326d4f3ed6
311372loratadine 10 MG 24HR Oral TabletPSN40914eeb-3a85-4691-9fb8-2df72ba1f7095
311372loratadine 10 MG Oral TabletSCD40914eeb-3a85-4691-9fb8-2df72ba1f7095
311372loratadine 10 MG 24 HR Oral TabletSY40914eeb-3a85-4691-9fb8-2df72ba1f7095
311372loratadine 10 MG 24HR Oral TabletPSNff1b0b4e-f74f-451d-8d13-4fa7077275473
311372loratadine 10 MG Oral TabletSCDff1b0b4e-f74f-451d-8d13-4fa7077275473
311372loratadine 10 MG 24 HR Oral TabletSYff1b0b4e-f74f-451d-8d13-4fa7077275473
311372loratadine 10 MG 24HR Oral TabletPSN8d8d5d50-f70c-4d7a-9c7e-0a6cbf7637982
311372loratadine 10 MG 24HR Oral TabletPSN332bda00-1350-2d33-e063-6394a90a8bd72
311372loratadine 10 MG 24HR Oral TabletPSN5990445c-d522-24cf-e053-2991aa0af4e62
311372loratadine 10 MG Oral TabletSCD8d8d5d50-f70c-4d7a-9c7e-0a6cbf7637982
311372loratadine 10 MG Oral TabletSCD5990445c-d522-24cf-e053-2991aa0af4e62
311372loratadine 10 MG Oral TabletSCD332bda00-1350-2d33-e063-6394a90a8bd72
311372loratadine 10 MG 24 HR Oral TabletSY8d8d5d50-f70c-4d7a-9c7e-0a6cbf7637982
311372loratadine 10 MG 24 HR Oral TabletSY5990445c-d522-24cf-e053-2991aa0af4e62
311372loratadine 10 MG 24 HR Oral TabletSY332bda00-1350-2d33-e063-6394a90a8bd72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
51660-526-03516600526035000 TABLET in 1 BAG (51660-526-03)5000 tablet28-NOV-24Current