CAREALL Allergy Relief

Product NDC
51824-103
11-digit product format
518240103
Labeler code
51824
Product ID
51824-103_44ebdb63-b21d-9745-e063-6294a90a9241
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
New World Imports
Application
ANDA210722
Marketing category
ANDA
Marketing start
2023-12-07
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 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
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
2026-02-19 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…

Additional Listing Data#

Finished product
Yes
Brand name base
CAREALL 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
4d15d926-9564-4bef-b8a9-768af7a0ab6aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-103-30CAREALL Allergy Relief30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-103-30EA - Each51824-10318e5e1aa-fa64-420e-b13e-5d7420b94e2712024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-103CAREALL ALLERGY RELIEF (LORATADINE) TABLET [NEW WORLD IMPORTS]1Current NDC, 1 package rows20231208_4d15d926-9564-4bef-b8a9-768af7a0ab6a.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 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefLORATADINEDr. Reddy's Laboratories Inc.44da36d2-1881-e779-d3a2-13ea828f92402026-07-15WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINESt. Mary's Medical Park Pharmacy2bc586e4-5297-44cf-e063-6294a90a531d2026-06-29WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINEPreferred Pharmaceuticals Inc.c6144a33-6b33-4aca-86e5-a3f688b8b3172026-05-28WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Allergy ReliefLORATADINEGrocery Outlet, Inc441cfa86-a812-f67f-e063-6394a90a21182026-05-21WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINENuCare Pharmaceuticals,Inc.16f00a3a-0777-f70c-e063-6294a90a71c92026-04-06WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
ALLERGY RELIEF 10 mgLORATADINETWIN MED LLCd943f548-aa0d-4476-e053-2a95a90a7bd42026-04-01WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Dr Simi All Day Allergy ReliefLORATADINEFarmacias De Similares TX LLC3c5b2eaa-24da-3314-e063-6294a90a5b212026-02-26WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINEGRANULES USA, INC.c3c9bc45-7ed5-abf4-e053-2995a90a40ff2025-12-22WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINESafeway, Incf2a2a754-0170-e37c-e053-2a95a90a4dca2025-12-19WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Loratadine 10mgLORATADINE 10MGMeijer181b7dd1-ddc4-e799-e063-6294a90a9faa2025-12-19WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINEWalgreensfd796139-ea9f-f4db-e053-6394a90acdf32025-12-19WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Allergy ReliefLORATADINEValu Merchandisers Company05927511-6b7a-4e29-96b4-3043493acf112025-12-11WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
CAREALL Allergy ReliefLORATADINENew World Imports4d15d926-9564-4bef-b8a9-768af7a0ab6a2025-12-01WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
ndc (product): 51824-103
Green Guard 24 Hour Allergy ReliefLORATADINEUnifirst First Aid Corporationf98a45fd-cda8-4884-e053-6294a90a57b52025-11-21WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Allergy ReliefLORATADINEWinCo Foods, LLC3dea627d-4b0c-e077-e063-6394a90a15a02025-11-03WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
McKesson LoratadineLORATADINE 10 MGMcKesson Medical Surgicalc6a3056e-792e-52a4-e053-2a95a90a83612025-10-23WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
First Aid Direct Allergy ReliefLORATADINE TABLETSCintas Corporation6b43e5a5-30a8-46ca-a44d-1e1abf567b512025-09-23WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINEGranules India Limited9bae1ba3-c0da-23a2-e053-2a95a90a58ed2025-08-01WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
Curist Allergy ReliefLORATADINE 10 MGLittle Pharma, Inc.0c53cf0f-7682-a422-e063-6394a90ab7642025-06-15WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722
LoratadineLORATADINEBryant Ranch Prepack0d74af21-3ef7-418b-a2ef-78737b0af2882025-06-13WarningsExact identifier
application applno (ANDA): 210722
application number: ANDA210722

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN4d15d926-9564-4bef-b8a9-768af7a0ab6a2
311372loratadine 10 MG Oral TabletSCD4d15d926-9564-4bef-b8a9-768af7a0ab6a2
311372loratadine 10 MG 24 HR Oral TabletSY4d15d926-9564-4bef-b8a9-768af7a0ab6a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51824-103-305182401033030 TABLET in 1 BOTTLE (51824-103-30) 30 tablet2023-12-07NoNoCurrent