LORATADINE ALLERGY RELIEF

Product NDC
73581-230
11-digit product format
735810230
Labeler code
73581
Product ID
73581-230_0e135981-fabe-f255-e063-6394a90ae356
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET
Route
ORAL
Labeler
YYBA CORP
Application
ANDA210722
Marketing category
ANDA
Marketing start
2022-04-15
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A210722-001LORATADINELORATADINE10MGTABLET / ORAL2019-12-23

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210722-001LORATADINE10MGTABLET / ORAL2019-12-2384e616aacf4f…
2026-08-18 06:07:402026-07A210722-001LORATADINE10MGTABLET / ORAL2019-12-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210722-001LORATADINE10MGTABLET / ORAL2019-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210722-001LORATADINE10MGTABLET / ORAL2019-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210722-001LORATADINE10MGTABLET / ORAL2019-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210722-001LORATADINE10MGTABLET / ORAL2019-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210722-001LORATADINE10MGTABLET / ORAL2019-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210722-001LORATADINE10MGTABLET / ORAL2019-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210722-001LORATADINE10MGTABLET / ORAL2019-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210722-001LORATADINE10MGTABLET / ORAL2019-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210722-001LORATADINE10MGTABLET / ORAL2019-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210722-001LORATADINE10MGTABLET / ORAL2019-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210722-001LORATADINE10MGTABLET / ORAL2019-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210722-001LORATADINE10MGTABLET / ORAL2019-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210722-001LORATADINE10MGTABLET / ORAL2019-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210722-001LORATADINE10MGTABLET / ORAL2019-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210722-001LORATADINE10MGTABLET / ORAL2019-12-234b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210722-001LORATADINE10MGTABLET / ORAL2019-12-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210722-001LORATADINE10MGTABLET / ORAL2019-12-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A210722-001LORATADINE10MGTABLET / ORAL2019-12-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210722-001LORATADINE10MGTABLET / ORAL2019-12-23c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210722-001LORATADINE10MGTABLET / ORAL2019-12-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210722-001LORATADINE10MGTABLET / ORAL2019-12-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210722-001LORATADINE10MGTABLET / ORAL2019-12-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210722-001LORATADINE10MGTABLET / ORAL2019-12-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210722-001LORATADINE10MGTABLET / ORAL2019-12-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210722-001LORATADINE10MGTABLET / ORAL2019-12-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A210722-001LORATADINE10MGTABLET / ORAL2019-12-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A210722-001LORATADINE10MGTABLET / ORAL2019-12-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210722-001LORATADINE10MGTABLET / ORAL2019-12-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210722-001LORATADINE10MGTABLET / ORAL2019-12-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210722-001LORATADINE10MGTABLET / ORAL2019-12-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210722-001LORATADINE10MGTABLET / ORAL2019-12-23cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210722-001LORATADINE10MGTABLET / ORAL2019-12-23a50c72e98297…

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
LORATADINE ALLERGY RELIEF
Brand name suffix
10mg
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
dcb63e1b-d499-2e84-e053-2995a90af5c7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73581-230-01LORATADINE ALLERGY RELIEF10mg100 in 1 BOTTLETABLET1003
73581-230-36LORATADINE ALLERGY RELIEF10mg365 in 1 BOTTLETABLET3653

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73581-230LORATADINE ALLERGY RELIEF 10MG (LORATADINE) TABLET [YYBA CORP]3Current NDC, Legacy NDC, 2 package rows20240104_dcb63e1b-d499-2e84-e053-2995a90af5c7.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 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ValuMeds Allergy ReliefLORATADINECabinet Health P.B.C.7a67f879-9df9-4536-8fd5-4b9aed05fb472025-02-28WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINEAdvanced Rx LLCe96b4671-82dc-4cc6-a8bf-ef6f1efd8a7d2025-02-25WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LORATADINELORATADINEAMZ789 LLCdb71197e-d633-644d-e053-2a95a90a261d2025-01-08WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINESpirit Pharmaceuticals LLCaf0cdab2-27a4-5f30-e053-2a95a90a5e712024-12-13WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
24 / 7 Life Non-Drowsy Allergy ReliefLORATADINE TABLETLil' Drug Store Products, Inc.efd0703f-f069-566e-e053-2995a90a74e42024-07-22WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Non-Drowsy Allergy Relief, 24-7 LifeLORATADINE TABLETLil' Drug Store Products, Inc.031ecc85-8324-4505-e063-6294a90a580b2024-04-10WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
XL - 3 AllergyXL - 3 ALLERGYSelder, S.A. de C.V.059a6e72-888e-4cb3-8722-4c3acbd6b4b02024-04-10WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LORATADINE ALLERGY RELIEF 10mgLORATADINEYYBA CORPdcb63e1b-d499-2e84-e053-2995a90af5c72024-01-03WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
ndc (product): 73581-230
Allergy ReliefLORATADINEAMERIFOODS TRADING COMPANYf6ce5292-f698-dd2f-e053-6394a90ad74a2023-11-02WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Allergy ReliefLORATADINEFSA STORE INC.ec6b31f3-ee68-1fbc-e053-2a95a90a05aa2023-01-12WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LORATADINELORATADINECamber Consumer Care Inc1e92f77f-d4ba-4f34-96f9-daf878b4ea6a2022-12-06WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Allergy ReliefLORATADINEAAA PHARMACEUTICAL, INC.9c8535e3-6a60-4640-b37e-a2260936d9af2022-04-21WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Allergy ReliefLORATADINEDISCOUNT DRUG MARTc29bf35f-1f19-c3c9-e053-2995a90ac1b62021-07-12WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Allergy ReliefLORATADINEHARRIS TEETERb8f67f52-906e-c7a8-e053-2995a90a5cbd2021-04-29WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Allergy ReliefLORATADINE 10MGFirst Aid Direct3a580dc7-ff09-462c-9b18-2051053490352020-11-12WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Allergy ReliefLORATADINEMarc Glassman, Inc.717ccb47-e13c-4464-b6e6-bea8f24d46632020-09-28WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Allergy ReliefLORATADINEAllegiant Healthf0db3a13-43e6-4243-9a3a-7808ddd005e12020-06-16WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNdcb63e1b-d499-2e84-e053-2995a90af5c73
311372loratadine 10 MG Oral TabletSCDdcb63e1b-d499-2e84-e053-2995a90af5c73
311372loratadine 10 MG 24 HR Oral TabletSYdcb63e1b-d499-2e84-e053-2995a90af5c73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73581-230-0173581023001100 TABLET in 1 BOTTLE (73581-230-01) 100 tablet2022-04-150000-00-00NoNoCurrent
73581-230-3673581023036365 TABLET in 1 BOTTLE (73581-230-36) 365 tablet2022-04-150000-00-00NoNoCurrent