Live Better

Product NDC
51143-092
11-digit product format
511430092
Labeler code
51143
Product ID
51143-092_f2e73f4c-202e-41bc-8d51-72fdad9273ab
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
The Great Atlantic & Pacific Tea Company
Application
ANDA076805
Marketing category
ANDA
Marketing start
2010-02-27
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51143-092IInactivated by FDA2026-08-03
excluded packagepackage51143-09251143-092-08IInactivated by FDA2026-08-03

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51143-092-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51143-092-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51143-092-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51143-092-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51143-092-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51143-092-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51143-092-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51143-092-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51143-092-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51143-092-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51143-092-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51143-092-08557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51143-092-088af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51143-092-08834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51143-092-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51143-092-08fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51143-092-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51143-092-08bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51143-092-088dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51143-092-08e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51143-092-089bebd1f3094a…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
A076805-001LORATADINELORATADINE1MG/MLSYRUP / ORAL2004-08-20

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 UTC2026-02A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203f01610625f2…
2019-09-15 20:21 UTC2019-09A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51143-092-082020-01-31C16284748780-19d75b9d0-5c26-f424-e053-dadaa90a57ceLive Better Loratadine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51143-092-08Live Better Loratadine120 mL in 1 BOTTLESOLUTION1201
51143-092-08Live Better Loratadine1 in 1 CARTONSOLUTION11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNLIVE BETTER LORATADINE (LORATADINE) SOLUTION [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]1
LoratadineACTIVE MOIETY7AJO3BO7QNLIVE BETTER LORATADINE (LORATADINE) SOLUTION [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXLIVE BETTER LORATADINE (LORATADINE) SOLUTION [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]1
phosphoric acidINACTIVE INGREDIENTE4GA8884NNLIVE BETTER LORATADINE (LORATADINE) SOLUTION [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALIVE BETTER LORATADINE (LORATADINE) SOLUTION [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LIVE BETTER LORATADINE (LORATADINE) SOLUTION [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EULIVE BETTER LORATADINE (LORATADINE) SOLUTION [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]1
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CLIVE BETTER LORATADINE (LORATADINE) SOLUTION [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]1
sodium phosphate, monobasic, dihydrateINACTIVE INGREDIENT5QWK665956LIVE BETTER LORATADINE (LORATADINE) SOLUTION [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]1
sorbitolINACTIVE INGREDIENT506T60A25RLIVE BETTER LORATADINE (LORATADINE) SOLUTION [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]1
waterINACTIVE INGREDIENT059QF0KO0RLIVE BETTER LORATADINE (LORATADINE) SOLUTION [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51143-092LIVE BETTER LORATADINE (LORATADINE) SOLUTION [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]1Legacy NDC, 2 package rows20130223_ae7efe12-460f-4857-bbf1-3417de3557e9.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens LoratadineLORATADINESun Pharmaceutical Industries, Inc.12c8066a-3429-481e-b63a-7ea2b439a1702026-07-14WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
Childrens LoratadineLORATADINESun Pharmaceutical Industries, Inc.78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d02026-04-08WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
Childrens Loratadine Sugar FreeLORATADINEPreferred Pharmaceuticals Inc.23936948-71bf-4c18-9160-22b7075e675d2026-01-15WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
Childrens Loratadine Sugar FreeLORATADINEWalgreen Company42a73448-104a-4c7f-aea0-cef44d15f5f12026-01-13WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
Childrens Loratadine Sugar FreeLORATADINEH E Bd710b760-794e-490b-a413-c7b2ee5149b92025-08-14WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
Childrens Loratadine Sugar FreeLORATADINESTRATEGIC SOURCING SERVICES LLC809456dc-1d1c-42a7-b17f-e43dacde927f2025-07-30WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
LoratadineLORATADINESTRATEGIC SOURCING SERVICES LLC6ba7fc5d-81c4-482c-8b38-4a6587853a9f2025-07-21WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
childrens allergyLORATADINEPublix Super Markets Incfa429380-019e-4ccd-8444-d5d931c4cc652025-07-15WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
Childrens Loratadine Sugar FreeLORATADINESun Pharmaceutical Industries, Inc.58eaab62-ac36-4080-8ded-9b472dddc6172025-07-02WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
Sunmark childrens loratadineLORATADINEStrategic Sourcing Services LLCed94cba7-c2c4-4cbe-9021-f554a51d51f22024-12-19WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
Childrens LoratadineLORATADINEStrategic Sourcing Services LLC280739e5-94e5-4d1e-ba65-2b4304cbac972024-12-19WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
Childrens Loratadine Sugar FreeLORATADINEAmerican Sales Company6977d7e0-9d01-4f5e-8d55-98dabb7195852024-12-09WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
LoratadineLORATADINECardinal Health, 110 dba LEADERdb9d2182-6bf1-424a-a144-f2694c47989f2021-06-23WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
Good Neighbor Pharmacy Childrens LoratadineLORATADINEAmerisourceBergen3ffc656a-90f9-4921-9c4f-840023b984332020-06-24WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805
Good Neighbor Pharmacy Childrens LoratadineLORATADINEAmerisourceBergen22d0714b-c1fe-4e77-92d8-aed3284813b42020-06-23WarningsExact identifier
application applno (ANDA): 076805
application number: ANDA076805

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSNae7efe12-460f-4857-bbf1-3417de3557e91
692783loratadine 1 MG/ML Oral SolutionSCDae7efe12-460f-4857-bbf1-3417de3557e91
692783loratadine 5 MG per 5 ML Oral SolutionSYae7efe12-460f-4857-bbf1-3417de3557e91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51143-092-0851143009208120 mL in 1 BOTTLE120 mlHistorical