health mart childrens allergy relief

Product NDC
62011-0371
11-digit product format
620110371
Labeler code
62011
Product ID
62011-0371_ce44fbc4-2fc2-4b29-b6a2-e2d7ba4189f4
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA210033
Marketing category
ANDA
Marketing start
2019-08-16
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62011-0371DDiscontinued by firm2026-08-03
excluded packagepackage62011-037162011-0371-1DDiscontinued by firm2026-08-03

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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-0371-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0371-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62011-0371-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62011-0371-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62011-0371-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62011-0371-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62011-0371-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62011-0371-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62011-0371-10efc9e666f02…f202fb6c5f17…

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
A210033-001LORATADINELORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-123f01610625f2…
2019-09-15 20:21 UTC2019-09A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12cb3db0bc1861…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Berkley and Jensen Childrens Allergy ReliefLORATADINEBJWC7f9b6a94-2be4-4c96-9a7d-8443f911a4cc2026-05-21WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033
good sense childrens allergy reliefLORATADINEL. Perrigo Company643dfe16-9cd1-47bb-8bce-303e6885c6442026-04-20WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033
ClaritinLORATADINEBayer HealthCare LLC.f3b9c643-a605-7702-e053-2995a90a61302025-12-04WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033
childrens allergy reliefLORATADINEMeijer Distribution Incb27f0bd0-4e61-4498-b5b7-54ae31f637f32025-05-07WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033
childrens allergy reliefLORATADINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDbc789b82-56ca-4248-b60a-252d9695636a2024-06-12WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033
foster and thrive childrens allergy reliefLORATADINEStrategic Sourcing Services LLC5ac59de8-46ad-4731-8f98-167fb5f8b0892023-10-30WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033
Equaline Childrens Allergy ReliefLORATADINEUnited Natural Foods, Inc. dba UNFI25329c7d-76e7-47b3-914e-ac367bbb750b2023-08-17WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033
topcare childrens allergy reliefLORATADINETopco Associates LLC4f7555ea-6286-4ff6-b125-d12660ae4bdf2023-06-20WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033
childrens allergy reliefLORATADINERite Aid Corporationf8ddeb7e-94b1-4dce-815f-b6b8c71e88fd2023-04-13WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033
Childrens Allergy ReliefLORATADINEH E B704ee04d-6bdd-4d0a-ba24-2a9fd79a90fb2021-08-24WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033
Basic Care Childrens Allergy ReliefLORATADINEAmazon.com Services LLCe2c83874-aa95-477a-9cfd-cecfd776ba0e2021-08-12WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033
careone childrens allergy reliefLORATADINEAmerican Sales Company06d1c443-ec23-4aa1-a7f3-f2b7ffcc25882020-08-10WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033
dg health childrens allergy reliefLORATADINEDolgencorp, LLC302fc570-bec9-43cb-8965-139576102cdd2020-06-10WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0371-16201103710130 BLISTER PACK in 1 CARTON (62011-0371-1) > 1 TABLET, CHEWABLE in 1 BLISTER PACK30 blister pack2019-08-160000-00-00NoNoCurrent