equate allergy relief

Product NDC
49035-612
11-digit product format
490350612
Labeler code
49035
Product ID
49035-612_ee35ff28-273b-4264-bef1-4a759d86a8be
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA076301
Marketing category
ANDA
Marketing start
2007-04-27
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49035-61249035-612-47DDiscontinued by firm2026-10-05
excluded packagepackage49035-61249035-612-65DDiscontinued by firm2026-10-05
excluded packagepackage49035-61249035-612-76DDiscontinued by firm2026-10-05

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 2025-12-0549035-612-76d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549035-612-47d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549035-612-65d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2649035-612-76f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649035-612-47f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649035-612-65f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3149035-612-762ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149035-612-472ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149035-612-652ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2849035-612-76a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849035-612-47a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849035-612-65a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2149035-612-76cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149035-612-47cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149035-612-65cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1049035-612-76cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049035-612-47cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049035-612-65cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3149035-612-76302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3149035-612-47302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3149035-612-65302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2049035-612-76ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2049035-612-47ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2049035-612-65ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1049035-612-760efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1049035-612-470efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1049035-612-650efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0849035-612-76ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0849035-612-47ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0849035-612-65ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0349035-612-76367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0349035-612-47367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0349035-612-65367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0949035-612-76557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0949035-612-47557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0949035-612-65557ba5c1ecfa…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.

Additional Listing Data#

Finished product
Yes
Brand name base
equate 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
dd36dc43-a9b7-4cda-86e0-9283d996a60aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-612-46equate allergy relief1 in 1 BLISTER PACKTABLET16
49035-612-46equate allergy relief10 in 1 CARTONTABLET106
49035-612-47equate allergy relief150 in 1 BOTTLETABLET1506
49035-612-65equate allergy relief1 in 1 CARTONTABLET16
49035-612-65equate allergy relief30 in 1 BOTTLETABLET306
49035-612-72equate allergy relief1 in 1 CARTONTABLET16
49035-612-72equate allergy relief60 in 1 BOTTLETABLET606
49035-612-76equate allergy relief2 in 1 CARTONTABLET26
49035-612-76equate allergy relief60 in 1 BOTTLETABLET606
49035-612-87equate allergy relief150 in 1 BOTTLETABLET1506
49035-612-87equate allergy relief2 in 1 PACKAGETABLET26
49035-612-95equate allergy relief45 in 1 BOTTLETABLET456
49035-612-95equate allergy relief1 in 1 CARTONTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-612-46EA - Each49035-61218ebb144-f1d5-4947-b996-1ea5dce89e4812013-06-04
49035-612-47EA - Each49035-6127fb018e3-9d4e-4894-a107-08b19a60b71612016-10-06
49035-612-65EA - Each49035-6124e99466b-2442-4536-8911-91754998060f12013-06-04
49035-612-72EA - Each49035-612511d5401-7718-40a3-b1cb-a418f1c0a35212012-07-24
49035-612-76EA - Each49035-61273b2f6b9-ce43-410e-b9fe-b489cde2ba3712022-06-06
49035-612-87EA - Each49035-612fa475230-c9cb-4f76-a707-81729989b10212021-11-09
49035-612-95EA - Each49035-6123d05874e-2e18-4a5c-b582-eda865cba4da12022-06-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-612EQUATE ALLERGY RELIEF (LORATADINE) TABLET [WAL-MART STORES INC]6Current NDC, Legacy NDC, 13 package rows20221206_dd36dc43-a9b7-4cda-86e0-9283d996a60a.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
ndc (product): 49035-612
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 TabletPSNdd36dc43-a9b7-4cda-86e0-9283d996a60a6
311372loratadine 10 MG Oral TabletSCDdd36dc43-a9b7-4cda-86e0-9283d996a60a6
311372loratadine 10 MG 24 HR Oral TabletSYdd36dc43-a9b7-4cda-86e0-9283d996a60a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-612-464903506124610 BLISTER PACK in 1 CARTON (49035-612-46) / 1 TABLET in 1 BLISTER PACK10 blister pack2012-02-280000-00-00NoNoCurrent
49035-612-4749035061247150 TABLET in 1 BOTTLE (49035-612-47) 150 tablet2012-03-010000-00-00NoNoCurrent
49035-612-65490350612651 BOTTLE in 1 CARTON (49035-612-65) > 30 TABLET in 1 BOTTLE1 bottle2012-02-290000-00-00NoNoCurrent
49035-612-72490350612721 BOTTLE in 1 CARTON (49035-612-72) / 60 TABLET in 1 BOTTLE1 bottle2007-04-270000-00-00NoNoCurrent
49035-612-76490350612762 BOTTLE in 1 CARTON (49035-612-76) > 60 TABLET in 1 BOTTLE2 bottle2015-02-030000-00-00NoNoCurrent
49035-612-87490350612872 BOTTLE in 1 PACKAGE (49035-612-87) / 150 TABLET in 1 BOTTLE2 bottle2012-03-010000-00-00NoNoCurrent
49035-612-95490350612951 BOTTLE in 1 CARTON (49035-612-95) / 45 TABLET in 1 BOTTLE1 bottle2013-08-200000-00-00NoNoCurrent