good neighbor pharmacy anti diarrheal

Product NDC
24385-554
Requested package NDC
24385-554-53
11-digit product format
243850554
Labeler code
24385
Product ID
24385-554_9764d636-0933-4926-8950-2e60ba594eef
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA075232
Marketing category
ANDA
Marketing start
2003-05-12
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
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 packagepackage24385-55424385-554-53DDiscontinued by firm2026-08-03

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-554-53EA - Each24385-554a32c03d4-5445-4c67-ae6b-8d43bd67eb8612012-07-24
24385-554-62EA - Each24385-554a3bad9e3-8988-4ffc-a0a1-6d5428940aaf12012-07-24
24385-554-67EA - Each24385-554446161a9-8d96-45f9-b1ca-bdc024e2cd3812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CGOOD NEIGHBOR PHARMACY ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [AMERISOURCE BERGEN]1
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIGOOD NEIGHBOR PHARMACY ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [AMERISOURCE BERGEN]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGOOD NEIGHBOR PHARMACY ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [AMERISOURCE BERGEN]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGOOD NEIGHBOR PHARMACY ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [AMERISOURCE BERGEN]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD NEIGHBOR PHARMACY ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [AMERISOURCE BERGEN]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGOOD NEIGHBOR PHARMACY ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [AMERISOURCE BERGEN]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGOOD NEIGHBOR PHARMACY ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [AMERISOURCE BERGEN]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD NEIGHBOR PHARMACY ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [AMERISOURCE BERGEN]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD NEIGHBOR PHARMACY ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [AMERISOURCE BERGEN]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD NEIGHBOR PHARMACY ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [AMERISOURCE BERGEN]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGOOD NEIGHBOR PHARMACY ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [AMERISOURCE BERGEN]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24385-554GOOD NEIGHBOR PHARMACY ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [AMERISOURCE BERGEN]5Legacy NDC20221109_48078785-0384-4ca5-bd95-a8b3602084ae.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 · 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
24385-554-532438505545312 BLISTER PACK in 1 CARTON (24385-554-53) > 1 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2003-07-080000-00-00NoNoCurrent