Lil Drug Store Anti-Diarrheal

Product NDC
66715-9859
11-digit product format
667159859
Labeler code
66715
Product ID
66715-9859_27e84982-bd9e-815b-e063-6394a90af111
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
ANDA074091
Marketing category
ANDA
Marketing start
2012-09-14
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage66715-985966715-9859-7DDiscontinued 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 · 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
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Lil Drug Store Anti-Diarrheal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
77TI35393CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
978010Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc23b13e-3005-4f23-aec2-b02a0e48ea11Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-9859-2Lil Drug Store Anti-Diarrheal1 in 1 CARTONTABLET17
66715-9859-2Lil Drug Store Anti-Diarrheal2 in 1 POUCHTABLET27
66715-9859-5Lil Drug Store Anti-Diarrheal25 in 1 BOX, UNIT-DOSETABLET257
66715-9859-5Lil Drug Store Anti-Diarrheal2 in 1 POUCHTABLET27
66715-9859-6Lil Drug Store Anti-Diarrheal30 in 1 BOX, UNIT-DOSETABLET307
66715-9859-6Lil Drug Store Anti-Diarrheal2 in 1 POUCHTABLET27
66715-9859-7Lil Drug Store Anti-Diarrheal2 in 1 POUCHTABLET27
66715-9859-7Lil Drug Store Anti-Diarrheal50 in 1 CARTONTABLET507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9859LIL DRUG STORE ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]7Current NDC, Legacy NDC, 8 package rows20241129_fc23b13e-3005-4f23-aec2-b02a0e48ea11.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
ndc (product): 66715-9859
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 TabletPSNfc23b13e-3005-4f23-aec2-b02a0e48ea117
978010loperamide hydrochloride 2 MG Oral TabletSCDfc23b13e-3005-4f23-aec2-b02a0e48ea117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9859-2667159859021 POUCH in 1 CARTON (66715-9859-2) / 2 TABLET in 1 POUCH1 pouch2014-09-010000-00-00NoNoCurrent
66715-9859-56671598590525 POUCH in 1 BOX, UNIT-DOSE (66715-9859-5) / 2 TABLET in 1 POUCH25 pouch2022-05-06NoNoCurrent
66715-9859-66671598590630 POUCH in 1 BOX, UNIT-DOSE (66715-9859-6) / 2 TABLET in 1 POUCH30 pouch2022-05-06NoNoCurrent
66715-9859-76671598590750 POUCH in 1 CARTON (66715-9859-7) > 2 TABLET in 1 POUCH50 pouch2016-06-202021-09-12NoNoCurrent