FDA.reportPublic FDA data

good sense allergy relief

Product NDC
0113-0612
11-digit product format
001130612
Labeler code
0113
Product ID
0113-0612_55d4d093-30f3-414d-b639-017b691d288d
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA076301
Marketing category
ANDA
Marketing start
2004-09-21
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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 packagepackage0113-06120113-0612-39DDiscontinued by firm2026-08-17
excluded packagepackage0113-06120113-0612-49DDiscontinued by firm2026-08-17
excluded packagepackage0113-06120113-0612-58DDiscontinued by firm2026-08-17
excluded packagepackage0113-06120113-0612-60DDiscontinued 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 · 24 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 2025-12-050113-0612-49d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050113-0612-58d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260113-0612-49f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260113-0612-58f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310113-0612-492ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310113-0612-582ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280113-0612-49a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280113-0612-58a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210113-0612-49cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210113-0612-58cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100113-0612-49cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100113-0612-58cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310113-0612-49302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310113-0612-58302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200113-0612-49ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200113-0612-58ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100113-0612-490efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100113-0612-580efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080113-0612-49ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080113-0612-58ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030113-0612-49367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030113-0612-58367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090113-0612-49557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090113-0612-58557ba5c1ecfa…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
good sense allergy relief
Listing expiration
2027-12-31

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
80e8a6e8-0c5f-4065-9545-112e146d25eeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0612-00good sense allergy relief300 in 1 BOTTLETABLET30011
0113-0612-39good sense allergy relief1 in 1 BLISTER PACKTABLET111
0113-0612-39good sense allergy relief30 in 1 CARTONTABLET3011
0113-0612-46good sense allergy relief10 in 1 CARTONTABLET1011
0113-0612-46good sense allergy relief1 in 1 BLISTER PACKTABLET111
0113-0612-49good sense allergy relief1 in 1 BLISTER PACKTABLET111
0113-0612-49good sense allergy relief40 in 1 CARTONTABLET4011
0113-0612-58good sense allergy relief1 in 1 CARTONTABLET111
0113-0612-58good sense allergy relief40 in 1 BOTTLETABLET4011
0113-0612-60good sense allergy relief20 in 1 CARTONTABLET2011
0113-0612-60good sense allergy relief1 in 1 BLISTER PACKTABLET111
0113-0612-65good sense allergy relief30 in 1 BOTTLETABLET3011
0113-0612-65good sense allergy relief1 in 1 CARTONTABLET111
0113-0612-75good sense allergy relief1 in 1 CARTONTABLET111
0113-0612-75good sense allergy relief90 in 1 BOTTLETABLET9011
0113-0612-78good sense allergy relief1 in 1 CARTONTABLET111
0113-0612-78good sense allergy relief100 in 1 BOTTLETABLET10011
0113-0612-87good sense allergy relief1 in 1 CARTONTABLET111
0113-0612-88good sense allergy relief1 in 1 CARTONTABLET111
0113-0612-88good sense allergy relief365 in 1 BOTTLETABLET36511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0612-39EA - Each0113-061286f2a010-0d4f-4493-bf69-1aeb299cda5812012-07-24
0113-0612-46EA - Each0113-0612c28011d4-b96a-4692-a8f3-37ff09e32c0b12012-07-24
0113-0612-60EA - Each0113-0612b0068e2b-774f-4c9a-86c2-4106420c384d12012-07-24
0113-0612-65EA - Each0113-0612e8601b6e-32f6-4a48-af0b-b3da948cf88912012-07-24
0113-0612-75EA - Each0113-061216ec9377-35e0-47e4-bcd7-7d4b05309b8612020-08-06
0113-0612-88EA - Each0113-061240985875-ae6a-4250-9d9b-194af5c60e9012025-10-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNGOOD SENSE ALLERGY RELIEF (LORATADINE) TABLET [L. PERRIGO COMPANY]5
LORATADINEACTIVE MOIETY7AJO3BO7QNGOOD SENSE ALLERGY RELIEF (LORATADINE) TABLET [L. PERRIGO COMPANY]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGOOD SENSE ALLERGY RELIEF (LORATADINE) TABLET [L. PERRIGO COMPANY]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE ALLERGY RELIEF (LORATADINE) TABLET [L. PERRIGO COMPANY]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD SENSE ALLERGY RELIEF (LORATADINE) TABLET [L. PERRIGO COMPANY]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0612GOOD SENSE ALLERGY RELIEF (LORATADINE) TABLET [L. PERRIGO COMPANY]9Current NDC, Legacy NDC, 20 package rows20220217_80e8a6e8-0c5f-4065-9545-112e146d25ee.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
good sense allergy reliefLORATADINEL. Perrigo Company80e8a6e8-0c5f-4065-9545-112e146d25ee2026-04-27WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
ndc (product): 0113-0612
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 TabletPSN80e8a6e8-0c5f-4065-9545-112e146d25ee11
311372loratadine 10 MG Oral TabletSCD80e8a6e8-0c5f-4065-9545-112e146d25ee11
311372loratadine 10 MG 24 HR Oral TabletSY80e8a6e8-0c5f-4065-9545-112e146d25ee11
311372loratadine 10 MG 24HR Oral TabletPSN5fda4906-4133-4293-8b39-4ddcf8d398013
311372loratadine 10 MG 24HR Oral TabletPSNc288d849-59c9-4883-aac4-bae54acee8ac3
311372loratadine 10 MG Oral TabletSCD5fda4906-4133-4293-8b39-4ddcf8d398013
311372loratadine 10 MG Oral TabletSCDc288d849-59c9-4883-aac4-bae54acee8ac3
311372loratadine 10 MG 24 HR Oral TabletSY5fda4906-4133-4293-8b39-4ddcf8d398013
311372loratadine 10 MG 24 HR Oral TabletSYc288d849-59c9-4883-aac4-bae54acee8ac3
311372loratadine 10 MG 24HR Oral TabletPSN9cc3d50a-81ce-4c9d-9721-209169a332e01
311372loratadine 10 MG Oral TabletSCD9cc3d50a-81ce-4c9d-9721-209169a332e01
311372loratadine 10 MG 24 HR Oral TabletSY9cc3d50a-81ce-4c9d-9721-209169a332e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0612-0000113061200300 in 1 BOTTLEHistorical
0113-0612-390011306123930 BLISTER PACK in 1 CARTON (0113-0612-39) > 1 TABLET in 1 BLISTER PACK30 blister pack2005-11-280000-00-00NoNoCurrent
0113-0612-460011306124610 BLISTER PACK in 1 CARTON (0113-0612-46) / 1 TABLET in 1 BLISTER PACK10 blister pack2004-09-210000-00-00NoNoCurrent
0113-0612-49001130612491 in 1 BLISTER PACKHistorical
0113-0612-58001130612581 in 1 CARTONHistorical
0113-0612-600011306126020 BLISTER PACK in 1 CARTON (0113-0612-60) > 1 TABLET in 1 BLISTER PACK20 blister pack2004-09-210000-00-00NoNoCurrent
0113-0612-65001130612651 BOTTLE in 1 CARTON (0113-0612-65) / 30 TABLET in 1 BOTTLE1 bottle2004-10-060000-00-00NoNoCurrent
0113-0612-75001130612751 BOTTLE in 1 CARTON (0113-0612-75) / 90 TABLET in 1 BOTTLE1 bottle2020-06-060000-00-00NoNoCurrent
0113-0612-78001130612781 BOTTLE in 1 CARTON (0113-0612-78) / 100 TABLET in 1 BOTTLE1 bottle2025-12-15NoNoCurrent
0113-0612-87001130612871 BOTTLE in 1 CARTON (0113-0612-87) / 300 TABLET in 1 BOTTLE (0113-0612-00)1 bottle2026-01-080Current
0113-0612-88001130612881 BOTTLE in 1 CARTON (0113-0612-88) / 365 TABLET in 1 BOTTLE1 bottle2004-09-210000-00-00NoNoCurrent