ValuMeds Allergy Relief Loratadine

Product NDC
82725-1142
11-digit product format
827251142
Labeler code
82725
Product ID
82725-1142_5241d239-3115-7faa-e063-6394a90a40b1
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET
Route
ORAL
Labeler
Cabinet Health P.B.C.
Application
ANDA214684
Marketing category
ANDA
Marketing start
2025-10-01
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A214684-001LORATADINELORATADINE10MGTABLET / ORAL2021-01-07

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
2026-02-19 14:30 UTC2026-02A214684-001LORATADINE10MGTABLET / ORAL2021-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214684-001LORATADINE10MGTABLET / ORAL2021-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A214684-001LORATADINE10MGTABLET / ORAL2021-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214684-001LORATADINE10MGTABLET / ORAL2021-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214684-001LORATADINE10MGTABLET / ORAL2021-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214684-001LORATADINE10MGTABLET / ORAL2021-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214684-001LORATADINE10MGTABLET / ORAL2021-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214684-001LORATADINE10MGTABLET / ORAL2021-01-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214684-001LORATADINE10MGTABLET / ORAL2021-01-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214684-001LORATADINE10MGTABLET / ORAL2021-01-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214684-001LORATADINE10MGTABLET / ORAL2021-01-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214684-001LORATADINE10MGTABLET / ORAL2021-01-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214684-001LORATADINE10MGTABLET / ORAL2021-01-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214684-001LORATADINE10MGTABLET / ORAL2021-01-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214684-001LORATADINE10MGTABLET / ORAL2021-01-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214684-001LORATADINE10MGTABLET / ORAL2021-01-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214684-001LORATADINE10MGTABLET / ORAL2021-01-074b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214684-001LORATADINE10MGTABLET / ORAL2021-01-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214684-001LORATADINE10MGTABLET / ORAL2021-01-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214684-001LORATADINE10MGTABLET / ORAL2021-01-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A214684-001LORATADINE10MGTABLET / ORAL2021-01-075aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214684-001LORATADINE10MGTABLET / ORAL2021-01-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214684-001LORATADINE10MGTABLET / ORAL2021-01-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214684-001LORATADINE10MGTABLET / ORAL2021-01-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214684-001LORATADINE10MGTABLET / ORAL2021-01-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214684-001LORATADINE10MGTABLET / ORAL2021-01-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214684-001LORATADINE10MGTABLET / ORAL2021-01-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214684-001LORATADINE10MGTABLET / ORAL2021-01-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A214684-001LORATADINE10MGTABLET / ORAL2021-01-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A214684-001LORATADINE10MGTABLET / ORAL2021-01-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214684-001LORATADINE10MGTABLET / ORAL2021-01-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214684-001LORATADINE10MGTABLET / ORAL2021-01-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214684-001LORATADINE10MGTABLET / ORAL2021-01-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214684-001LORATADINE10MGTABLET / ORAL2021-01-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214684-001LORATADINE10MGTABLET / ORAL2021-01-07a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
ValuMeds Allergy Relief Loratadine
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
43bc8e38-bd74-411c-b4fe-7d809d24ae46Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82725-1142-1ValuMeds Allergy Relief Loratadine365 in 1 BOTTLETABLET3652

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINENuCare Pharmaceuticals, Inc.569a35be-d653-181c-e063-6294a90a6eb92026-07-14WarningsExact identifier
application applno (ANDA): 214684
application number: ANDA214684
LoratadineLORATADINEPreferred Pharmaceuticals Inc0a0d700d-bdba-4c90-a947-5d61d40ce4df2026-05-28WarningsExact identifier
application applno (ANDA): 214684
application number: ANDA214684
ValuMeds Allergy Relief LoratadineLORATADINECabinet Health P.B.C.43bc8e38-bd74-411c-b4fe-7d809d24ae462026-05-20WarningsExact identifier
application applno (ANDA): 214684
application number: ANDA214684
ndc (product): 82725-1142
LoratadineLORATADINEStrategic Sourcing Services, LLCa527f83a-4ae9-47b1-94e0-7ab3148b025f2026-01-29WarningsExact identifier
application applno (ANDA): 214684
application number: ANDA214684
LoratadineLORATADINECabinet Health P.B.C.8b090fa2-9535-456c-b14d-187a2873cdf72025-10-27WarningsExact identifier
application applno (ANDA): 214684
application number: ANDA214684
CVS LoratadineLORATADINECVS Pharmacy3d716988-da63-59e6-e063-6394a90a5b4b2025-10-22WarningsExact identifier
application applno (ANDA): 214684
application number: ANDA214684
Nuvicare-Allergy Relief Loratadine Tablets, 10 mgLORATADINENUVICARE LLC023a46f0-8d1c-4f62-953d-3e6458a54f6e2025-07-01WarningsExact identifier
application applno (ANDA): 214684
application number: ANDA214684
Gencare-Allergy Relief Loratadine Tablets, 10 mgLORATADINEPioneer Life Sciences, LLC647dc957-4aee-48f6-bb77-e82d3b380e802025-06-30WarningsExact identifier
application applno (ANDA): 214684
application number: ANDA214684
LoratadineLORATADINEGobrands, Inc1d182bd6-ad72-4352-b983-407a48c317f02025-01-25WarningsExact identifier
application applno (ANDA): 214684
application number: ANDA214684
LoratadineLORATADINEAdvanced Rx Pharmacy of Tennessee, LLC01cb43cf-57a9-f189-e063-6294a90afd882024-12-31WarningsExact identifier
application applno (ANDA): 214684
application number: ANDA214684
LoratadineLORATADINERising Pharmaceuticals, Incd28128a3-af54-440e-9bd4-0fccf393d18a2022-03-10WarningsExact identifier
application applno (ANDA): 214684
application number: ANDA214684

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN43bc8e38-bd74-411c-b4fe-7d809d24ae462
311372loratadine 10 MG Oral TabletSCD43bc8e38-bd74-411c-b4fe-7d809d24ae462
311372loratadine 10 MG 24 HR Oral TabletSY43bc8e38-bd74-411c-b4fe-7d809d24ae462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82725-1142-182725114201365 TABLET in 1 BOTTLE (82725-1142-1) 365 tablet2025-10-01NoNoCurrent