LORATADINE

Product NDC
69842-686
11-digit product format
698420686
Labeler code
69842
Product ID
69842-686_4deaf048-b4b9-546e-e063-6394a90a4fdb
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS HEALTH CORP
Application
ANDA206214
Marketing category
ANDA
Marketing start
2017-01-31
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 42.

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
A206214-001LORATADINELORATADINE10MGCAPSULE / ORAL2016-09-23

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-233f01610625f2…
2019-09-15 20:21 UTC2019-09A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23e64feba35796…

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
828269Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
899800a7-89bc-4a39-88b0-f19d78934dafAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-686-07LORATADINE10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED106
69842-686-07LORATADINE1 in 1 CARTONCAPSULE, LIQUID FILLED16
69842-686-30LORATADINE3 in 1 CARTONCAPSULE, LIQUID FILLED36
69842-686-30LORATADINE10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED106
69842-686-60LORATADINE10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED106
69842-686-60LORATADINE6 in 1 CARTONCAPSULE, LIQUID FILLED66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-686LORATADINE CAPSULE, LIQUID FILLED [CVS HEALTH CORP]5Current NDC, Legacy NDC, 6 package rows20221118_899800a7-89bc-4a39-88b0-f19d78934daf.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALLERGY RELIEFLORATADINECARDINAL HEALTH 110, LLC. DBA LEADER052e0ea2-441f-42cc-b62c-f2574f995bff2026-03-31WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
LORATADINELORATADINECVS HEALTH CORP899800a7-89bc-4a39-88b0-f19d78934daf2026-03-26WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
ndc (product): 69842-686
LORATADINELORATADINEKROGER COMPANY0599cc64-419d-452f-ac50-ac03110067292025-12-29WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
Allergy ReliefLORATADINESafeway8a1b3d40-8ec4-7e76-e053-2a95a90a84b12025-04-30WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
ALLERGY RELIEFLORATADINETARGET CORPORATION7cb1364b-0852-3444-e053-2991aa0a36292025-02-01WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
Allergy ReliefLORATADINECHAIN DRUG MARKETING ASSOCIATION, INC.e0cb8057-4755-482d-84f4-9275f7b85cd02024-08-12WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
WAL-ITINLORATADINEWALGREENS9e155aae-4735-4aab-bda9-c21ea29529a42022-11-11WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
LoratadineLORATADINEMARKSANS PHARMA LIMITEDc30907f9-1761-41e5-bd4e-2613e756e1c62021-11-15WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
LORATADINELORATADINESMART SENSE (KMART)c2db3398-ead6-4bb6-8aa6-f1366a8461442018-05-16WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214
LORATADINELORATADINETIME CAP LABORATORIES INC85b26cf3-448c-4d4f-93a2-aa89530ec1f12018-05-16WarningsExact identifier
application applno (ANDA): 206214
application number: ANDA206214

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828269loratadine 10 MG 24HR Oral CapsulePSN899800a7-89bc-4a39-88b0-f19d78934daf6
828269loratadine 10 MG Oral CapsuleSCD899800a7-89bc-4a39-88b0-f19d78934daf6
828269loratadine 10 MG 24HR Oral CapsuleSY899800a7-89bc-4a39-88b0-f19d78934daf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-686-07698420686071 BLISTER PACK in 1 CARTON (69842-686-07) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2017-01-310000-00-00NoNoCurrent
69842-686-30698420686303 BLISTER PACK in 1 CARTON (69842-686-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2017-01-310000-00-00NoNoCurrent
69842-686-60698420686606 BLISTER PACK in 1 CARTON (69842-686-60) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK6 blister pack2017-01-310000-00-00NoNoCurrent