FDA.reportPublic FDA data

Loratadine

Product NDC
69842-242
11-digit product format
698420242
Labeler code
69842
Product ID
69842-242_434285f9-116c-458e-a598-fcdcd7be2825
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
ANDA208314
Marketing category
ANDA
Marketing start
2019-08-26
Substance
LORATADINE
Active strength
10 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 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
A208314-001LORATADINELORATADINE10MGTABLET / ORAL2018-04-16

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 UTC2026-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208314-001LORATADINE10MGTABLET / ORAL2018-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208314-001LORATADINE10MGTABLET / ORAL2018-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208314-001LORATADINE10MGTABLET / ORAL2018-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208314-001LORATADINE10MGTABLET / ORAL2018-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A208314-001LORATADINE10MGTABLET / ORAL2018-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A208314-001LORATADINE10MGTABLET / ORAL2018-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208314-001LORATADINE10MGTABLET / ORAL2018-04-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 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
311372Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3937f769-e8e2-4b32-8338-21b0a74a8697Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-242-09Loratadine10 in 1 BLISTER PACKTABLET109
69842-242-09Loratadine3 in 1 CARTONTABLET39
69842-242-17Loratadine45 in 1 BOTTLETABLET459
69842-242-17Loratadine1 in 1 CARTONTABLET19
69842-242-19Loratadine1 in 1 CARTONTABLET19
69842-242-19Loratadine90 in 1 BOTTLETABLET909
69842-242-39Loratadine365 in 1 BOTTLETABLET3659
69842-242-45Loratadine2 in 1 CARTONTABLET29
69842-242-45Loratadine120 in 1 BOTTLETABLET1209
69842-242-54Loratadine1 in 1 CARTONTABLET19
69842-242-54Loratadine70 in 1 BOTTLETABLET709
69842-242-60Loratadine1 in 1 CARTONTABLET19
69842-242-60Loratadine5 in 1 BLISTER PACKTABLET59
69842-242-67Loratadine10 in 1 BLISTER PACKTABLET109
69842-242-67Loratadine2 in 1 CARTONTABLET29
69842-242-83Loratadine1 in 1 CARTONTABLET19
69842-242-83Loratadine10 in 1 BLISTER PACKTABLET109
69842-242-91Loratadine3 in 1 CARTONTABLET39
69842-242-91Loratadine10 in 1 BLISTER PACKTABLET109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-242-39EA - Each69842-24232246d33-ff47-485c-86b5-a158cc91330d12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-242LORATADINE TABLET [CVS PHARMACY, INC.]8Current NDC, Legacy NDC, 19 package rows20250516_3937f769-e8e2-4b32-8338-21b0a74a8697.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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINEKROGER COMPANYb96831f5-5e75-c526-e053-2995a90a36ad2026-05-04WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
CONTAC AllergyLORATADINEVespyr Brands LLC4587a61d-139e-2a5b-e063-6394a90a13112026-05-01WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEPreferred Pharmaceuticals Inc.7ca5050a-328a-4aff-8954-58f092e3ed6b2026-04-21WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINECVS Pharmacy, Inc.3937f769-e8e2-4b32-8338-21b0a74a86972026-03-20WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
ndc (product): 69842-242
AMAZON BASIC CARE ALLERGY RELIEFLORATADINEAmazon.com Services LLC113da68e-f658-082a-e063-6294a90ad9292026-03-18WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEAurobindo Pharma Limited4f4ffb72-f4e8-4617-8bc5-61e6de488a2d2025-11-12WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEA-S Medication Solutionsc84c2696-0d55-48a2-9d32-ca6c9bc57aa22025-11-11WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEA-S Medication Solutions26c19e5b-7288-41a2-baaf-b4af196301402025-11-10WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
365 Whole Foods Market LoratadineLORATADINEWhole Foods Market, Inc.bba4e7c8-db8e-4522-915c-48ee809e3bce2025-06-11WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEMajor Pharmaceuticals98e41ae1-677a-4583-9a0a-edba29ebbc302024-06-29WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEWALGREEN CO.c016aad8-df83-99b0-e053-2a95a90a49cf2024-06-24WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINECardinal Healthc96dd1c9-85a0-0792-e053-2a95a90a22642024-06-14WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
ALLERGY RELIEF 10mgLORATADINEYYBA CORP6103cf98-40b1-4d27-8eb7-6f6a069497302024-01-03WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEChain Drug Consortium, LLC21199958-ac67-4f72-8a8c-4d7d31fa9da42022-11-04WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEMcLane Company, Inc.f988f9fb-463d-4aaa-b83d-54a3b114e5702022-11-04WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEAurohealth LLC839e2e03-9ebb-4a44-b753-fb174bd361152022-11-03WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEWinco Foods, LLC.2a6cf697-0084-4522-bc89-b3e0f96a598d2022-08-17WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEBluePoint Laboratoriesadc506ed-7a7a-facc-e053-2a95a90ae1472022-06-20WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEAurohealth LLCc6bfb54a-04d8-41c1-9fa9-5d4bae0a66d12022-06-18WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314
LoratadineLORATADINEAurohealth LLC196da80c-3dbb-40c7-ac93-8a57d6acb1c32020-08-13WarningsExact identifier
application applno (ANDA): 208314
application number: ANDA208314

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN3937f769-e8e2-4b32-8338-21b0a74a86979
311372loratadine 10 MG Oral TabletSCD3937f769-e8e2-4b32-8338-21b0a74a86979
311372loratadine 10 MG 24 HR Oral TabletSY3937f769-e8e2-4b32-8338-21b0a74a86979

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-242-09698420242093 BLISTER PACK in 1 CARTON (69842-242-09) / 10 TABLET in 1 BLISTER PACK3 blister pack2019-08-260000-00-00NoNoCurrent
69842-242-17698420242171 BOTTLE in 1 CARTON (69842-242-17) / 45 TABLET in 1 BOTTLE1 bottle2019-08-260000-00-00NoNoCurrent
69842-242-19698420242191 BOTTLE in 1 CARTON (69842-242-19) / 90 TABLET in 1 BOTTLE1 bottle2019-08-260000-00-00NoNoCurrent
69842-242-3969842024239365 TABLET in 1 BOTTLE (69842-242-39) 365 tablet2019-08-260000-00-00NoNoCurrent
69842-242-45698420242452 BOTTLE in 1 CARTON (69842-242-45) / 120 TABLET in 1 BOTTLE2 bottle2019-08-260000-00-00NoNoCurrent
69842-242-54698420242541 BOTTLE in 1 CARTON (69842-242-54) / 70 TABLET in 1 BOTTLE1 bottle2019-08-260000-00-00NoNoCurrent
69842-242-60698420242601 BLISTER PACK in 1 CARTON (69842-242-60) / 5 TABLET in 1 BLISTER PACK1 blister pack2019-08-260000-00-00NoNoCurrent
69842-242-67698420242672 BLISTER PACK in 1 CARTON (69842-242-67) / 10 TABLET in 1 BLISTER PACK2 blister pack2019-08-260000-00-00NoNoCurrent
69842-242-83698420242831 BLISTER PACK in 1 CARTON (69842-242-83) / 10 TABLET in 1 BLISTER PACK1 blister pack2019-08-260000-00-00NoNoCurrent
69842-242-91698420242913 BLISTER PACK in 1 CARTON (69842-242-91) / 10 TABLET in 1 BLISTER PACK3 blister pack2019-08-260000-00-00NoNoCurrent