FDA.reportPublic FDA data

Allergy Relief

Product NDC
51660-527
11-digit product format
516600527
Labeler code
51660
Product ID
51660-527_7b87d8ea-1102-4642-8a39-b2504dbda716
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA077153
Marketing category
ANDA
Marketing start
2007-08-31
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51660-527-31e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51660-527-319bebd1f3094a…5416666fcb17…

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
A077153-001LORATADINE REDIDOSELORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11

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 UTC2026-02A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-113f01610625f2…
2019-09-15 20:21 UTC2019-09A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077153-001LORATADINE REDIDOSE10MGTABLET, ORALLY DISINTEGRATING / ORAL2007-04-11cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
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
311373Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de3a7725-5d1b-4195-a9f8-43f92888997cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51660-527-312021-04-06C16284748780-19d75b9d0-a8c7-f424-e053-dadaa90a57ceDrug Facts
51660-527-312020-01-31C16284748780-19d75b9d0-a8c7-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-527-31Allergy Relief30 in 1 CARTONTABLET, ORALLY DISINTEGRATING306
51660-527-31Allergy Relief1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-527-31EA - Each51660-5272f06cc31-d825-4951-ad09-c82e0a47a14c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNALLERGY RELIEF (LORATADINE) TABLET, ORALLY DISINTEGRATING [OHM LABORATORIES INC.]5
LORATADINEACTIVE MOIETY7AJO3BO7QNALLERGY RELIEF (LORATADINE) TABLET, ORALLY DISINTEGRATING [OHM LABORATORIES INC.]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ALLERGY RELIEF (LORATADINE) TABLET, ORALLY DISINTEGRATING [OHM LABORATORIES INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY RELIEF (LORATADINE) TABLET, ORALLY DISINTEGRATING [OHM LABORATORIES INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (LORATADINE) TABLET, ORALLY DISINTEGRATING [OHM LABORATORIES INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AALLERGY RELIEF (LORATADINE) TABLET, ORALLY DISINTEGRATING [OHM LABORATORIES INC.]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIALLERGY RELIEF (LORATADINE) TABLET, ORALLY DISINTEGRATING [OHM LABORATORIES INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-527ALLERGY RELIEF (LORATADINE) TABLET, ORALLY DISINTEGRATING [OHM LABORATORIES INC.]6Current NDC, Legacy NDC, 2 package rows20210407_de3a7725-5d1b-4195-a9f8-43f92888997c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefLORATADINEOhm Laboratories Inc.de3a7725-5d1b-4195-a9f8-43f92888997c2021-04-06WarningsExact identifier
application applno (ANDA): 077153
application number: ANDA077153
ndc (product): 51660-527

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSNde3a7725-5d1b-4195-a9f8-43f92888997c6
311373loratadine 10 MG Disintegrating Oral TabletSCDde3a7725-5d1b-4195-a9f8-43f92888997c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-527-315166005273130 BLISTER PACK in 1 CARTON (51660-527-31) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK30 blister pack2007-08-310000-00-00NoNoCurrent