welby childrens allergy relief

Product NDC
64024-023
11-digit product format
640240023
Labeler code
64024
Product ID
64024-023_402c635d-4116-4767-baa9-e956fed02884
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Aldi Inc
Application
ANDA075728
Marketing category
ANDA
Marketing start
2022-03-02
Substance
LORATADINE
Active strength
5 mg/5mL
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 42.

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
A075728-001LORATADINELORATADINE1MG/MLSYRUP / ORAL2004-08-20

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203f01610625f2…
2019-09-15 20:21 UTC2019-09A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075728-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
welby childrens allergy relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/5mL

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
692783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
402c635d-4116-4767-baa9-e956fed02884Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64024-023-26welby childrens allergy relief1 in 1 CARTONSOLUTION11
64024-023-26welby childrens allergy relief120 mL in 1 BOTTLESOLUTION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64024-023WELBY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [ALDI INC]1Current NDC, Legacy NDC, 2 package rows20220928_402c635d-4116-4767-baa9-e956fed02884.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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens allergy reliefLORATADINEKroger Company52934db1-b6fc-43ca-9a8c-66ff47a947452026-06-29WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
Good Sense childrens allergy reliefLORATADINEPreferred Pharmaceuticals Inc.27bb0a40-35ee-4c19-bd6f-fb054c8a25862026-05-28WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
Childrens Loratadine OralLORATADINEA-S Medication Solutions0a42baae-554b-4b93-8780-fe45c42fabc02026-03-18WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
CHILDRENS ALLERGY RELIEFLORATADINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0e84571d-87b6-4742-ac62-9ed68a115c722026-03-17WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
Childrens Loratadine OralLORATADINEAtlantic Biologicals4a1a6981-133c-d45b-e063-6294a90a4a092026-02-05WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
Childrens Loratadine OralLORATADINEMajor Pharmaceuticals3f0f0131-b516-4ff3-8049-3d3766324b662025-11-13WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
Good Sense childrens allergy reliefLORATADINENuCare Pharmaceuticals,Inc.40d25cdf-b63f-d5c9-e063-6394a90af5092025-10-10WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
basic care childrens allergy reliefLORATADINEAmazon.com Services LLC90f40330-46a6-44cf-9b09-6f791c9b210b2025-05-12WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
Equaline Childrens Allergy ReliefLORATADINEUnited Natural Foods, Inc. dba UNFI11e889d8-833c-4043-a1af-7ffaf3fda61d2025-05-07WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
dg health childrens allergyLORATADINEDolgencorp, LLC14acf572-e1f0-40f5-82cf-357cb2f3a0512025-05-07WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
good sense childrens allergy reliefLORATADINEL. Perrigo Company4ce244e2-9fbc-4371-8806-789fd3a61a092025-05-06WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
childrens allergy reliefLORATADINEMeijer, Inc.f71d9155-e5fb-4735-86f6-59dd9abf6be02025-05-05WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
equate childrens allergyLORATADINEWal-Mart Stores Inc5603d5e1-8d95-44b9-aceb-4bc37b162ab12025-05-05WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
childrens allergy reliefLORATADINERite Aid Corporation539336e6-7979-47ed-b1ea-fd46ef547aee2025-05-05WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
Good Sense childrens allergy reliefLORATADINEL. Perrigo Company637e309d-9846-45a1-ad11-f67ea85c87b82025-05-05WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
good neighbor pharmacy childrens loratadineLORATADINEAmerisource Bergen46cdccaf-a6f2-4a49-a2b0-7ba0df17bfa82024-11-19WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
UP AND UP CHILDRENS ALLERGYLORATADINETarget Corporationa9f6ae02-cf29-4111-99e7-7e6b1ecb88f02024-07-31WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
Childrens AllergyLORATADINECVS Pharmacy13c40819-24af-48f1-8371-9e32dc5339a12024-07-26WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
welby childrens allergy reliefLORATADINEAldi Inc402c635d-4116-4767-baa9-e956fed028842022-09-26WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728
ndc (product): 64024-023
topcare childrens allergyLORATADINETopco Associates LLC6e175fae-05dd-45c2-b9ab-7d49369a3c052022-02-28WarningsExact identifier
application applno (ANDA): 075728
application number: ANDA075728

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN402c635d-4116-4767-baa9-e956fed028841
692783loratadine 1 MG/ML Oral SolutionSCD402c635d-4116-4767-baa9-e956fed028841
692783loratadine 5 MG per 5 ML Oral SolutionSY402c635d-4116-4767-baa9-e956fed028841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64024-023-26640240023261 BOTTLE in 1 CARTON (64024-023-26) / 120 mL in 1 BOTTLE1 bottle2022-03-020000-00-00NoNoCurrent