Equaline Allergy Relief

Product NDC
41163-612
11-digit product format
411630612
Labeler code
41163
Product ID
41163-612_8c0efba7-030e-4273-8eb8-6b0f3f1847cf
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Supervalu Inc
Application
ANDA076301
Marketing category
ANDA
Marketing start
2005-02-07
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct41163-612IInactivated by FDA2026-10-12
excluded packagepackage41163-61241163-612-46IInactivated by FDA2026-10-12
excluded packagepackage41163-61241163-612-58DDiscontinued by firm2026-10-12
excluded packagepackage41163-61241163-612-60DDiscontinued by firm2026-10-12
excluded packagepackage41163-61241163-612-65IInactivated by FDA2026-10-12
excluded packagepackage41163-61241163-612-72IInactivated by FDA2026-10-12
excluded packagepackage41163-61241163-612-75IInactivated by FDA2026-10-12
excluded packagepackage41163-61241163-612-78IInactivated by FDA2026-10-12
excluded packagepackage41163-61241163-612-95DDiscontinued by firm2026-10-12

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 · 36 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 2025-12-0541163-612-58d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0541163-612-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0541163-612-95d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2641163-612-58f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2641163-612-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2641163-612-95f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3141163-612-582ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3141163-612-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3141163-612-952ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2841163-612-58a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2841163-612-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2841163-612-95a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2141163-612-58cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2141163-612-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2141163-612-95cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1041163-612-58cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1041163-612-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1041163-612-95cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3141163-612-58302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3141163-612-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3141163-612-95302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2041163-612-58ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2041163-612-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2041163-612-95ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1041163-612-580efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1041163-612-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1041163-612-950efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0841163-612-58ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0841163-612-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0841163-612-95ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0341163-612-58367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0341163-612-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0341163-612-95367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0941163-612-58557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0941163-612-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0941163-612-95557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-2584e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-612-46Equaline Allergy Relief10 in 1 CARTONTABLET108
41163-612-46Equaline Allergy Relief1 in 1 BLISTER PACKTABLET18
41163-612-58Equaline Allergy Relief1 in 1 CARTONTABLET18
41163-612-58Equaline Allergy Relief40 in 1 BOTTLETABLET408
41163-612-60Equaline Allergy Relief20 in 1 CARTONTABLET208
41163-612-60Equaline Allergy Relief1 in 1 BLISTER PACKTABLET18
41163-612-65Equaline Allergy Relief1 in 1 CARTONTABLET18
41163-612-65Equaline Allergy Relief30 in 1 BOTTLETABLET308
41163-612-72Equaline Allergy Relief60 in 1 BOTTLETABLET608
41163-612-72Equaline Allergy Relief1 in 1 CARTONTABLET18
41163-612-75Equaline Allergy Relief1 in 1 CARTONTABLET18
41163-612-75Equaline Allergy Relief90 in 1 BOTTLETABLET908
41163-612-78Equaline Allergy Relief100 in 1 BOTTLETABLET1008
41163-612-78Equaline Allergy Relief1 in 1 CARTONTABLET18
41163-612-95Equaline Allergy Relief45 in 1 BOTTLETABLET458
41163-612-95Equaline Allergy Relief1 in 1 CARTONTABLET18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-612-46EA - Each41163-612abfcb81a-368b-4fae-92be-13bc023c202112012-07-24
41163-612-60EA - Each41163-612911a470f-6bd8-4388-b5e0-5c630ed93d2112012-07-24
41163-612-65EA - Each41163-612b06b6b37-680f-4f78-9e27-d75c931be72412012-07-24
41163-612-72EA - Each41163-61281d99ec1-c2e7-4093-b1d5-3226e4be884512012-07-24
41163-612-75EA - Each41163-612e73b37cc-e219-4c9a-aa20-3351432d191312012-07-24
41163-612-95EA - Each41163-612fed995f4-bc6f-4520-87d1-91494870902712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNEQUALINE ALLERGY RELIEF (LORATADINE) TABLET [SUPERVALU INC]3
LORATADINEACTIVE MOIETY7AJO3BO7QNEQUALINE ALLERGY RELIEF (LORATADINE) TABLET [SUPERVALU INC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEQUALINE ALLERGY RELIEF (LORATADINE) TABLET [SUPERVALU INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EQUALINE ALLERGY RELIEF (LORATADINE) TABLET [SUPERVALU INC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EEQUALINE ALLERGY RELIEF (LORATADINE) TABLET [SUPERVALU INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-612EQUALINE ALLERGY RELIEF (LORATADINE) TABLET [UNITED NATURAL FOODS, INC. DBA UNFI]8Legacy NDC, 16 package rows20241211_232053f0-737b-46b0-959f-9edb26d82cbf.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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Allergy ReliefLORATADINECardinal Health 110, LLC. dba Leader6f5134c6-ece6-4e35-a0c3-13e0dfa173fa2025-04-01WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
up and up allergy reliefLORATADINETarget Corporationc4ef0110-89c3-4ded-9a9a-75c0f794f8692025-03-28WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
TopCare Allergy Relief 24 hourLORATADINETopco Associates LLCa500aebf-a020-4da9-afdb-a699077cb8e12025-03-28WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINENuCare Pharmaceuticals,Inc.fc63689e-e449-ca8f-e053-6394a90a54a22025-02-05WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINENuCare Pharmaceuticals,Inc.54b37bcc-a8b0-0c17-e054-00144ff8d46c2025-01-09WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
foster and thrive allergy reliefLORATADINEStrategic Sourcing Services LLCaff1ab34-51b0-488c-931e-c95aad2265722024-12-11WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
good neighbor pharmacy loratadineLORATADINEAmerisource Bergen9dda0f0b-fbab-47ee-8db8-95bd126fc61c2024-12-11WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
exchange select allergy reliefLORATADINEArmy & Air Force Exchange Serviceea5622d9-4e71-4a1f-9200-6b4cecac12152024-12-02WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
good sense allergy reliefLORATADINEA-S Medication Solutions9cc3d50a-81ce-4c9d-9721-209169a332e02024-08-21WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
allergy reliefLORATADINEMeijer Distribution Inc9261a02b-db43-462f-9f06-fb5624070e202024-08-06WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINEAphena Pharma Solutions - Tennessee, LLCa2c92766-df4e-4414-9c42-e18bcf9db6b42024-04-09WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
good sense allergy reliefLORATADINEA-S Medication Solutionsc288d849-59c9-4883-aac4-bae54acee8ac2024-03-27WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
members mark allergy reliefLORATADINESam's West Inc95c2b45a-d0e5-467c-aad4-7bbb6c9a52042024-03-11WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
good sense allergy reliefLORATADINEA-S Medication Solutions5fda4906-4133-4293-8b39-4ddcf8d398012024-02-04WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
kirkland signature allerclearLORATADINECostco Wholesale Company2074d52e-8c0a-4e69-bfb1-864ffc07e25f2024-01-17WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
equate allergy reliefLORATADINEWal-Mart Stores Incdd36dc43-a9b7-4cda-86e0-9283d996a60a2022-12-05WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
basic care allergy reliefLORATADINEAmazon.com Services LLCa4a7f024-972b-4a16-9cb8-28954c2a74c62022-10-18WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
Loratadine antihistamineLORATADINEProficient Rx LPe9b87f79-ebed-4677-8e50-00cb4282ee562022-04-01WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
LoratadineLORATADINEAphena Pharma Solutions - Tennessee, LLC8ffe2faf-3253-4121-a069-6f46e319c6f02020-05-13WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301
good sense allergy reliefLORATADINEL. Perrigo Company74bed4ad-5afe-4293-bef3-e0b9d5f64a292019-12-05WarningsExact identifier
application applno (ANDA): 076301
application number: ANDA076301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN232053f0-737b-46b0-959f-9edb26d82cbf8
311372loratadine 10 MG Oral TabletSCD232053f0-737b-46b0-959f-9edb26d82cbf8
311372loratadine 10 MG 24 HR Oral TabletSY232053f0-737b-46b0-959f-9edb26d82cbf8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-612-464116306124610 BLISTER PACK in 1 CARTON (41163-612-46) > 1 TABLET in 1 BLISTER PACK10 blister pack2005-02-070000-00-00NoNoCurrent
41163-612-58411630612581 BOTTLE in 1 CARTON (41163-612-58) > 40 TABLET in 1 BOTTLE1 bottle2019-10-030000-00-00NoNoCurrent
41163-612-604116306126020 in 1 CARTONHistorical
41163-612-65411630612651 BOTTLE in 1 CARTON (41163-612-65) > 30 TABLET in 1 BOTTLE1 bottle2005-02-150000-00-00NoNoCurrent
41163-612-72411630612721 BOTTLE in 1 CARTON (41163-612-72) > 60 TABLET in 1 BOTTLE1 bottle2005-03-230000-00-00NoNoCurrent
41163-612-75411630612751 BOTTLE in 1 CARTON (41163-612-75) > 90 TABLET in 1 BOTTLE1 bottle2005-03-210000-00-00NoNoCurrent
41163-612-7841163061278100 in 1 BOTTLEHistorical
41163-612-954116306129545 in 1 BOTTLEHistorical