Anti Diarrheal

Product NDC
30142-998
11-digit product format
301420998
Labeler code
30142
Product ID
30142-998_27dc547f-e6e8-4ea5-b11b-b3c68ca8da36
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kroger Company
Application
ANDA075232
Marketing category
ANDA
Marketing start
2003-02-21
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct30142-998DDiscontinued by firm2026-08-03
excluded packagepackage30142-99830142-998-23DDiscontinued by firm2026-08-03
excluded packagepackage30142-99830142-998-53DDiscontinued by firm2026-08-03
excluded packagepackage30142-99830142-998-62DDiscontinued by firm2026-08-03
excluded packagepackage30142-99830142-998-67DDiscontinued by firm2026-08-03

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage30142-998-67d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage30142-998-62d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage30142-998-23d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage30142-998-53d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage30142-998-67f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage30142-998-62f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage30142-998-23f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage30142-998-53f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage30142-998-672ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage30142-998-622ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage30142-998-232ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage30142-998-532ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage30142-998-67a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage30142-998-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage30142-998-23a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage30142-998-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage30142-998-67cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage30142-998-62cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage30142-998-23cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage30142-998-53cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage30142-998-67cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage30142-998-62cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage30142-998-23cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage30142-998-53cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage30142-998-67302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage30142-998-62302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage30142-998-23302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage30142-998-53302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage30142-998-67ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage30142-998-62ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage30142-998-23ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage30142-998-53ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage30142-998-670efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage30142-998-620efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage30142-998-230efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage30142-998-530efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage30142-998-67ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage30142-998-62ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage30142-998-23ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage30142-998-53ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage30142-998-67367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage30142-998-62367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage30142-998-23367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage30142-998-53367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage30142-998-67557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage30142-998-62557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage30142-998-23557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage30142-998-53557ba5c1ecfa…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
A075232-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06

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 UTC2026-02A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063f01610625f2…
2019-09-15 20:21 UTC2019-09A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06cb3db0bc1861…

DailyMed Socrata Ingredients#

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 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense anti diarrhealLOPERAMIDE HYDROCHLORIDEL. Perrigo Company9c1d811d-f8d0-418c-aaf7-7b6477deea202026-05-20WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
berkley and jensen anti diarrhealLOPERAMIDE HYDROCHLORIDEBJWCdc29a8e9-f916-49d2-b9a6-d2b4537d7b582026-05-08WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
anti diarrhealLOPERAMIDE HCLWalgreen Company6e0dfbb3-6c58-40fc-83b4-09ee10576ae52026-03-01WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
Good Sense anti diarrhealLOPERAMIDE HYDROCHLORIDEPreferred Pharmaceuticals Inc.803f492d-183d-423f-b05c-48f06dc9f2a52026-01-19WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
anti diarrhealLOPERAMIDE HYDROCHLORIDEHyVee Inc9434cefe-6b13-47c4-b2f7-b8d566c5a4ff2026-01-13WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
Good Sense anti diarrhealLOPERAMIDE HYDROCHLORIDENorthwind Health Company, LLCdb47cc0a-e301-0310-e053-2a95a90a7f5d2026-01-01WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
anti diarrhealLOPERAMIDE HYDROCHLORIDEPublix Super Markets Inc44773392-eac8-48b3-ae46-b27f5fe55d8d2025-12-28WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
CareOne Diarrhea ControlLOPERAMIDE HCLAmerican Sales Company17569b2c-38f9-43bd-87ac-eb82b64866e62025-12-17WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
topcare anti diarrhealLOPERAMIDE HYDROCHLORIDETopco Associates LLCda347b47-d8a5-4cf9-9579-79e6fe57fed52025-12-13WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
anti diarrhealLOPERAMIDE HYDROCHLORIDEMajor Pharmaceuticalsbe8f1c7d-fd4e-48d4-80b0-1d92a2ba6a702025-12-06WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
Imodium A-DLOPERAMIDE HYDROCHLORIDEKenvue Brands LLC01da76d0-1979-4c45-9d39-c72ae4e4ffe22025-09-23WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
Leader Anti DiarrhealLOPERAMIDE HCLCardinal Health 110, LLC. dba Leader9079a59b-a158-4e77-a104-547959f7ba782025-07-18WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
Up and Up anti diarrhealLOPERAMIDE HYDROCHLORIDETarget Corporationddb70e85-168e-451a-ac04-f6a46721a5572025-06-02WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
anti diarrhealLOPERAMIDE HYDROCHLORIDERedpharm Drug Incf4c23673-056e-7608-e053-2995a90a92762025-01-23WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
Anti DiarrhealLOPERAMIDE HCLH E B8ecbfd81-fe45-49b4-b835-a32192de8f532024-12-02WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
dg health anti diarrhealLOPERAMIDE HYDROCHLORIDEDolgencorp, LLCcac9e7e9-fb3a-497e-866d-347530ba4dfd2024-11-11WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
injoy diarrhea reliefLOPERAMIDE HCLL. Perrigo Companycf5ccdf8-ab27-429f-a1b4-c51ced0210462024-08-12WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
anti diarrhealLOPERAMIDE HYDROCHLORIDEMeijer Distribution Inc06a0530b-b06a-466b-b366-82a2a9f7c05c2024-06-19WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
foster and thrive anti diarrhealLOPERAMIDE HCLStrategic Sourcing Services LLC6f70564a-4400-4ed0-960b-09135a2f3a7c2023-12-07WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
anti diarrhealLOPERAMIDE HYDROCHLORIDECVS Pharmacyd8a55fb6-bb57-42d6-8e20-67fc91f380972023-10-13WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-998-23301420998231 BOTTLE in 1 CARTON (30142-998-23) > 72 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-02-250000-00-00NoNoCurrent
30142-998-533014209985312 BLISTER PACK in 1 CARTON (30142-998-53) > 1 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2003-03-070000-00-00NoNoCurrent
30142-998-623014209986224 BLISTER PACK in 1 CARTON (30142-998-62) > 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2003-02-210000-00-00NoNoCurrent
30142-998-67301420998671 BOTTLE in 1 CARTON (30142-998-67) > 48 TABLET, FILM COATED in 1 BOTTLE1 bottle2004-03-310000-00-00NoNoCurrent