Allergy Relief

Product NDC
69230-312
Requested package NDC
69230-312-01
11-digit product format
692300312
Labeler code
69230
Product ID
69230-312_7992f72f-e7b7-4e1d-9eb6-ca01603f0f55
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Camber Consumer Care
Application
ANDA075209
Marketing category
ANDA
Marketing start
2018-12-31
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69230-31269230-312-01DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A075209-001LORATADINELORATADINE10MGTABLET / ORAL2003-01-21

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 UTC2026-02A075209-001LORATADINE10MGTABLET / ORAL2003-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075209-001LORATADINE10MGTABLET / ORAL2003-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075209-001LORATADINE10MGTABLET / ORAL2003-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075209-001LORATADINE10MGTABLET / ORAL2003-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075209-001LORATADINE10MGTABLET / ORAL2003-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075209-001LORATADINE10MGTABLET / ORAL2003-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075209-001LORATADINE10MGTABLET / ORAL2003-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075209-001LORATADINE10MGTABLET / ORAL2003-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075209-001LORATADINE10MGTABLET / ORAL2003-01-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075209-001LORATADINE10MGTABLET / ORAL2003-01-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075209-001LORATADINE10MGTABLET / ORAL2003-01-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075209-001LORATADINE10MGTABLET / ORAL2003-01-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075209-001LORATADINE10MGTABLET / ORAL2003-01-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-213f01610625f2…
2019-09-15 20:21 UTC2019-09A075209-001LORATADINE10MGTABLET / ORAL2003-01-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075209-001LORATADINE10MGTABLET / ORAL2003-01-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075209-001LORATADINE10MGTABLET / ORAL2003-01-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075209-001LORATADINE10MGTABLET / ORAL2003-01-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A075209-001LORATADINE10MGTABLET / ORAL2003-01-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A075209-001LORATADINE10MGTABLET / ORAL2003-01-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075209-001LORATADINE10MGTABLET / ORAL2003-01-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075209-001LORATADINE10MGTABLET / ORAL2003-01-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69230-312-012020-10-20Drug Facts
69230-312-032020-10-20Drug Facts
69230-312-302020-10-20Drug Facts
69230-312-012020-09-27Drug Facts
69230-312-032020-09-27Drug Facts
69230-312-302020-09-27Drug Facts
69230-312-012020-09-25Drug Facts
69230-312-032020-09-25Drug Facts
69230-312-302020-09-25Drug Facts
69230-312-012020-07-22Drug Facts
69230-312-032020-07-22Drug Facts
69230-312-302020-07-22Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-312-01EA - Each69230-3123745cfb2-7e68-472a-a55b-8f069d92083612019-03-12
69230-312-03EA - Each69230-3125df7dc3d-48cf-4a34-9fcf-cfe458fe652c12019-03-12
69230-312-30EA - Each69230-312eefe15b8-51ef-4b1a-9993-e149a639a43912019-03-12

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 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
All Day Allergy ReliefLORATADINEWALMART INC. (see also Equate)db815af2-4193-4fd9-a028-4a9d54325ca82026-06-18WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
All Day Allergy ReliefLORATADINEWALMART INC. (see also Equate)80958503-400c-422a-a641-e1a3d5a9a6a82026-04-17WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
LoratadineLORATADINENuCare Pharmaceuticals,Inc.c0e3057d-2dd2-de2b-e053-2995a90a1a1d2026-03-05WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
All Day Allergy ReliefLORATADINESafeway, Inc.9e581ae1-d1e6-4038-86e8-fd0c5ab9878a2026-01-05WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
ClaritinLORATADINESelect Consumer Group3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e2025-12-28WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
ClaritinLORATADINEBayer HealthCare LLC.acf2d393-53d7-062f-e053-2995a90a0d602025-12-04WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
ClaritinLORATADINEBayer HealthCare LLC.dc65f7ec-bb83-7b29-e053-2995a90a99de2025-12-04WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
All Day Allergy ReliefLORATADINEFamily Dollar (FAMILY WELLNESS)6b8d786e-2ee3-487f-bf7b-7dc738ea2fc92025-10-29WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Allergy reliefLORATADINEPreferred Pharmaceuticals Inc.836f566c-0296-408a-ad2a-6a77e18552182025-08-29WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Wal-itinLORATADINEWalgreens6afa8056-1b7a-48a4-960c-92927169977e2025-08-28WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Allergy reliefLORATADINEGeri-Care Pharmaceutical Corpb66f171a-7b95-b27a-e053-2a95a90a60092025-07-28WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Allergy ReliefLORATADINEWinCo Foods, LLC706a59fa-3d15-4e6e-a38e-ad3f2ef466002025-04-08WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
CounterAct AllergyLORATADINEMelaleuca, Inc.6b5d43ad-a709-4e0b-b91c-36ea0afe72212025-03-17WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Allergy reliefLORATADINEBryant Ranch Prepacke87aa69c-9ec6-482d-8e28-32542f6b91662025-02-04WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Allergy reliefLORATADINEA-S Medication Solutions210fa77a-e33e-48c4-8228-b1cf3ccb7fa42025-01-30WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
ClaritinLORATADINE TABLETLil' Drug Store Products, Inc.f0e77162-c601-1a0f-e053-2a95a90ab7142024-12-31WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
All Day Allergy ReliefLORATADINEQUALITY CHOICE (Chain Drug Marketing Association)a282d209-1015-4570-b9df-7cc0a3753e372024-06-17WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
Allergy ReliefLORATADINEQUALITY CHOICE (Chain Drug Marketing Association)c5acd9d7-2f26-41c5-b369-2122251583ec2024-05-17WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
All Day Allergy ReliefLORATADINEQUALITY CHOICE (Chain Drug Marketing Association)d47a5f1b-fb27-4618-a26e-a5eeabcd87f22024-05-16WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209
All Day Allergy ReliefLORATADINEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)7eac9202-bd4c-4550-a257-2b8195a0dbcd2023-11-29WarningsExact identifier
application applno (ANDA): 075209
application number: ANDA075209

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN0607e8b0-b231-47bb-8133-10d46e7c0ac74
311372loratadine 10 MG Oral TabletSCD0607e8b0-b231-47bb-8133-10d46e7c0ac74
311372loratadine 10 MG 24 HR Oral TabletSY0607e8b0-b231-47bb-8133-10d46e7c0ac74
311372loratadine 10 MG 24HR Oral TabletPSNc4b5ae13-da50-49d4-a76c-b2b3969596dd1
311372loratadine 10 MG Oral TabletSCDc4b5ae13-da50-49d4-a76c-b2b3969596dd1
311372loratadine 10 MG 24 HR Oral TabletSYc4b5ae13-da50-49d4-a76c-b2b3969596dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69230-312-01692300312011 BOTTLE, PLASTIC in 1 CARTON (69230-312-01) > 100 TABLET in 1 BOTTLE, PLASTIC2018-12-310000-00-00NoNoCurrent