foster and thrive childrens allergy relief

Product NDC
70677-1043
11-digit product format
706771043
Labeler code
70677
Product ID
70677-1043_e4dfb921-4f17-4a55-93c2-85d9f74edac9
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
2023-10-30
Substance
LORATADINE
Active strength
5 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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-10-28 04:53 UTC2022-10A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12f41ea6bd6efb…

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
foster and thrive childrens allergy relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 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
665078Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ac59de8-46ad-4731-8f98-167fb5f8b089Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1043-1foster and thrive childrens allergy relief1 in 1 BLISTER PACKTABLET, CHEWABLE12
70677-1043-1foster and thrive childrens allergy relief30 in 1 CARTONTABLET, CHEWABLE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1043-1EA - Each70677-1043b9f220e2-6c00-409e-a86e-13015ea57cff12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1043FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF (LORATADINE) TABLET, CHEWABLE [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 2 package rows20231031_5ac59de8-46ad-4731-8f98-167fb5f8b089.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 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
ndc (product): 70677-1043
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665078loratadine 5 MG 24HR Chewable TabletPSN5ac59de8-46ad-4731-8f98-167fb5f8b0892
665078loratadine 5 MG Chewable TabletSCD5ac59de8-46ad-4731-8f98-167fb5f8b0892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1043-17067710430130 BLISTER PACK in 1 CARTON (70677-1043-1) / 1 TABLET, CHEWABLE in 1 BLISTER PACK30 blister pack2023-10-30NoNoCurrent