Loratadine

Product NDC
30142-996
11-digit product format
301420996
Labeler code
30142
Product ID
30142-996_6f7f7005-22db-4b88-9771-e31c21e9b2b1
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
KROGER COMPANY
Application
ANDA210088
Marketing category
ANDA
Marketing start
2019-05-22
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210088-001LORATADINELORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16
A210088-002LORATADINELORATADINE10MGTABLET, CHEWABLE / ORAL2025-04-25

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 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210088-002LORATADINE10MGTABLET, CHEWABLE / ORAL2025-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210088-002LORATADINE10MGTABLET, CHEWABLE / ORAL2025-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210088-002LORATADINE10MGTABLET, CHEWABLE / ORAL2025-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210088-001LORATADINE5MGTABLET, CHEWABLE / ORAL2018-04-163a93d1ddd44b…

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine
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
6f7f7005-22db-4b88-9771-e31c21e9b2b1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-996-30Loratadine3 in 1 CARTONTABLET, CHEWABLE31
30142-996-30Loratadine10 in 1 BLISTER PACKTABLET, CHEWABLE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-996LORATADINE TABLET, CHEWABLE [KROGER COMPANY]1Current NDC, Legacy NDC, 2 package rows20190523_6f7f7005-22db-4b88-9771-e31c21e9b2b1.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 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DYE-FREE LORATADINELORATADINEOhm Laboratories Inc.48744daa-7079-283d-e063-6394a90a2c9a2026-05-05WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
Dye-Free Childrens LoratadineLORATADINECVS PHARMACY, INCaf6e6e60-8e39-45a8-bb76-50403aef96682026-03-11WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
DYE-FREE CHILDRENS LORATADINELORATADINEWAL-MART STORES, INCec24da65-23c1-419d-9603-08348d3b9cc72025-04-04WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
CHILDRENS LORATADINELORATADINESAFEWAYdad93ac1-ae0b-4918-8c62-92107e79a4b22024-12-29WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
LoratadineLORATADINEWALGREEN COMPANY645c26ab-08ab-4a69-ae7d-7802d8ec59222024-12-29WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
Wal-itinLORATADINEWalgreens176fe4f5-f72d-4fc2-bd9a-20626c9ab6342024-12-27WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
LoratadineLORATADINEPremier Valuedc22862e-fe91-4900-8c2b-1ca45aeedbf02024-12-27WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
CHILDRENS LORATADINELORATADINETARGET CORPORATIONc02ad905-2363-4092-a90e-3be789112cb12024-12-27WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
Childrens AllergyLORATADINETARGET CORPORATION9507c223-ea75-477e-b765-f5d0bcba5ff92024-12-27WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
LoratadineLORATADINEWALGREENS CO.c9e12155-a699-4fa7-aac8-da7d5ddab4ae2024-11-19WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
Curist Childrens Allergy ReliefLORATADINE 5 MG CHEWABLE TABLETSLittle Pharma, Inc.1ab6a653-0b7c-69d7-e063-6394a90aacad2024-09-03WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
CHILDRENS LORATADINELORATADINETARGET CORPORATIONc5e87776-71e3-4c46-a8e7-30f47f437bef2024-06-28WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
Dye-Free Childrens LoratadineLORATADINEUP & UP85ea5c40-d02f-4c91-8eb2-4b16877e1eab2024-06-28WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
LoratadineLORATADINEKROGER COMPANY087ee83f-71aa-3d47-e063-6394a90aed4d2024-05-08WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
DYE-FREE CHILDRENS LORATADINELORATADINEOhm Laboratories Inc.10b0e325-335b-05b6-e063-6394a90a8c2f2024-03-15WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
Dye-Free Childrens LoratadineLORATADINEOhm Laboratories Inc.9e9b2e1c-f565-42ef-9ec4-43bcebc549b72024-03-15WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
Dye-Free Childrens LoratadineLORATADINECVS PHARMACY, INC0b78fed4-69eb-f66f-e063-6294a90a3b892024-03-15WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
CHILDRENS LORATADINELORATADINESAFEWAY0e0fbbf7-a42e-e101-e063-6294a90a69772024-03-15WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
Wal-itinLORATADINEWALGREENS CO.fb9608d9-b401-40d9-aff3-2bc0dc6e92d82024-03-15WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088
DYE-FREE CHILDRENS LORATADINELORATADINEPUBLIX SUPER MARKETS, INC0b29afdc-3b0f-3958-e063-6394a90a233a2024-03-15WarningsExact identifier
application applno (ANDA): 210088
application number: ANDA210088

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665078loratadine 5 MG 24HR Chewable TabletPSN6f7f7005-22db-4b88-9771-e31c21e9b2b11
665078loratadine 5 MG Chewable TabletSCD6f7f7005-22db-4b88-9771-e31c21e9b2b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-996-30301420996303 BLISTER PACK in 1 CARTON (30142-996-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2019-05-220000-00-00NoNoCurrent