FDA.reportPublic FDA data

childrens allergy relief

Product NDC
72288-929
11-digit product format
722880929
Labeler code
72288
Product ID
72288-929_ee272d7b-7c64-4b40-a5c2-bd0f2973acb4
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA210033
Marketing category
ANDA
Marketing start
2026-10-16
Substance
LORATADINE
Active strength
5 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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12c2088c7a36db…
2026-09-14 22:38:342026-08A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1284e616aacf4f…
2026-08-18 06:07:402026-07A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12caaa826d4ba7…
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…

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
childrens allergy relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/1

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
childrens allergy reliefLORATADINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDbc789b82-56ca-4248-b60a-252d9695636a2026-09-29WarningsExact identifier
application applno (ANDA): 210033
application number: ANDA210033
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
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 startSampleExclude flagStatus
72288-929-017228809290120 BLISTER PACK in 1 CARTON (72288-929-01) / 1 TABLET, CHEWABLE in 1 BLISTER PACK20 blister pack2026-10-16NoNoCurrent