Stomach Relief Anti Diarrheal

Product NDC
52904-443
11-digit product format
529040443
Labeler code
52904
Product ID
52904-443_21a6698d-3c80-4dfa-98d9-afd5546822b4
Type
HUMAN OTC DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Select Corporation
Application
ANDA074091
Marketing category
ANDA
Marketing start
2012-10-15
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52904-443IInactivated by FDA2026-08-03
excluded packagepackage52904-44352904-443-50IInactivated by FDA2026-08-03

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 · 30 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 packagepackage52904-443-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-443-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-443-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-443-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-443-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-443-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-443-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-443-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-443-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-443-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52904-443-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52904-443-50557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52904-443-508af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52904-443-50834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52904-443-501332a3947898…d4bfe170f9cd…

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
A074091-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10

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 UTC2026-02A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52904-443-502024-01-30C16284748780-11030e365-4980-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-443-02Stomach Relief Anti Diarrheal2 in 1 PACKETTABLET22
52904-443-06Stomach Relief Anti Diarrheal1 in 1 CARTONTABLET12
52904-443-50Stomach Relief Anti Diarrheal25 in 1 BOXTABLET252

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-443STOMACH RELIEF ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [SELECT CORPORATION]2Legacy NDC, 3 package rows20180209_de26457a-55a6-4fad-96d9-04697e157c09.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDESportpharm LLCeb93a17e-7daf-4a9e-94a1-442039a383bd2026-06-26WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
MEDIQUE DiamodeLOPERAMIDE HYDROCHLORIDESportpharm LLCac674e5a-94df-4a35-9854-4e66cc17e5092026-04-24WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Private Label DistributorLOPERAMIDE HCL 2 MGUnifirst First Aid Corporation069e7979-a223-4819-b6cf-ea2731bf156b2025-12-01WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
MEDIQUE DiamodeLOPERAMIDE HYDROCHLORIDEProficient Rx LP9cf77219-c98d-487a-a5d3-61ceda6c65f52025-10-01WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEMedline Industries, LP03d68bcf-6413-4fe3-8263-39cc315452d22024-12-29WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Anti-DiarrhealLOPERAMIDE HCILil' Drug Store Products, Inc.eec84fa1-262f-6e77-e053-2995a90a325b2024-12-29WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Anti-Diarrheal, Circle KLOPERAMIDE HCL TABLETLil' Drug Store Products, Inc.d3aaad65-f4cd-5eb0-e053-2995a90ade842024-12-29WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Anti-Diarrheal, Caseys 4goodLOPERAMIDE HCLLil' Drug Store Products, Inc.043b0ab4-8fba-37d1-e063-6394a90a4cd42024-12-29WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Lil Drug Store Anti-DiarrhealLOPERAMIDE HYDROCHLORIDELil' Drug Store Products, Inc.fc23b13e-3005-4f23-aec2-b02a0e48ea112024-11-27WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEChain Drug Consortium, LLCb070896b-1e22-41d4-a66d-8d3be16992172024-01-11WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEZee Medical Inc07e1f89c-5bf6-4539-848a-4435e7deb0d22024-01-11WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEOhm Laboratories Inc.c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c62024-01-11WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEDiscount Drug Mart6bc9771d-09f8-47ce-bbbd-8dd9aae976932024-01-11WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEMarc Glassman, Inc.01efdce1-25ce-45ff-aeb6-f6fba00e59aa2024-01-11WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEValu Merchandisers Company33335063-49a9-4e08-9d77-4cd80e94f0212024-01-11WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEFred's Inc.a3bf91ae-22f3-4402-b73c-de026f2d04752024-01-11WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEChain Drug Marketing Association Inc.237b845b-0f02-410d-9750-c95123e6142d2024-01-11WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Handy Solutions Anti-DiarrhealLOPERAMIDE HYDROCHLORIDENavajo Manufacturing Company Inc.76e32e66-4af5-47a5-83ff-cbba206975d62023-03-15WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEProficient Rx LP82e65393-25b7-4114-9c71-5840ee8bad842022-05-02WarningsExact identifier
application applno (ANDA): 074091
application number: ANDA074091

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNde26457a-55a6-4fad-96d9-04697e157c092
978010loperamide hydrochloride 2 MG Oral TabletSCDde26457a-55a6-4fad-96d9-04697e157c092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52904-443-02529040443022 in 1 PACKETHistorical
52904-443-06529040443061 in 1 CARTONHistorical
52904-443-505290404435025 CARTON in 1 BOX (52904-443-50) > 1 PACKET in 1 CARTON (52904-443-06) > 2 TABLET in 1 PACKET (52904-443-02) 25 carton2012-10-150000-00-00NoNoCurrent