Home NDC 66715-5759-2 Circle K Anti-Diarrheal
Product NDC 66715-5759
Requested package NDC 66715-5759-2
11-digit product format 667155759
Labeler code 66715
Product ID 66715-5759_28af9d56-7868-4d45-ab00-4dae3a47de40
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 2014-11-01
Marketing end 2022-12-03
Substance LOPERAMIDE HYDROCHLORIDE
Active strength 2 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074091-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 cb3db0bc1861…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Loperamide Hydrochloride ACTIVE INGREDIENT 77TI35393C CIRCLE K ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC] 1 Loperamide ACTIVE MOIETY 6X9OC3H4II CIRCLE K ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC] 1 aluminum oxide INACTIVE INGREDIENT LMI26O6933 CIRCLE K ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC] 1 Anhydrous Lactose INACTIVE INGREDIENT 3SY5LH9PMK CIRCLE K ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC] 1 Croscarmellose Sodium INACTIVE INGREDIENT M28OL1HH48 CIRCLE K ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC] 1 Crospovidone INACTIVE INGREDIENT 68401960MK CIRCLE K ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC] 1 D&C yellow NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CIRCLE K ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC] 1 FD&C blue NO. 1 INACTIVE INGREDIENT H3R47K3TBD CIRCLE K ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 CIRCLE K ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC] 1 Powdered Cellulose INACTIVE INGREDIENT SMD1X3XO9M CIRCLE K ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC] 1 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ CIRCLE K ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC] 1
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Sportpharm LLC eb93a17e-7daf-4a9e-94a1-442039a383bd 2026-06-26 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 MEDIQUE Diamode LOPERAMIDE HYDROCHLORIDE Sportpharm LLC ac674e5a-94df-4a35-9854-4e66cc17e509 2026-04-24 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Private Label Distributor LOPERAMIDE HCL 2 MG Unifirst First Aid Corporation 069e7979-a223-4819-b6cf-ea2731bf156b 2025-12-01 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 MEDIQUE Diamode LOPERAMIDE HYDROCHLORIDE Proficient Rx LP 9cf77219-c98d-487a-a5d3-61ceda6c65f5 2025-10-01 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Medline Industries, LP 03d68bcf-6413-4fe3-8263-39cc315452d2 2024-12-29 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Anti-Diarrheal LOPERAMIDE HCI Lil' Drug Store Products, Inc. eec84fa1-262f-6e77-e053-2995a90a325b 2024-12-29 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Anti-Diarrheal, Circle K LOPERAMIDE HCL TABLET Lil' Drug Store Products, Inc. d3aaad65-f4cd-5eb0-e053-2995a90ade84 2024-12-29 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Anti-Diarrheal, Caseys 4good LOPERAMIDE HCL Lil' Drug Store Products, Inc. 043b0ab4-8fba-37d1-e063-6394a90a4cd4 2024-12-29 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Lil Drug Store Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE Lil' Drug Store Products, Inc. fc23b13e-3005-4f23-aec2-b02a0e48ea11 2024-11-27 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Chain Drug Consortium, LLC b070896b-1e22-41d4-a66d-8d3be1699217 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Zee Medical Inc 07e1f89c-5bf6-4539-848a-4435e7deb0d2 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Ohm Laboratories Inc. c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c6 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Discount Drug Mart 6bc9771d-09f8-47ce-bbbd-8dd9aae97693 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Marc Glassman, Inc. 01efdce1-25ce-45ff-aeb6-f6fba00e59aa 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Valu Merchandisers Company 33335063-49a9-4e08-9d77-4cd80e94f021 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Fred's Inc. a3bf91ae-22f3-4402-b73c-de026f2d0475 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Chain Drug Marketing Association Inc. 237b845b-0f02-410d-9750-c95123e6142d 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Handy Solutions Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE Navajo Manufacturing Company Inc. 76e32e66-4af5-47a5-83ff-cbba206975d6 2023-03-15 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Proficient Rx LP 82e65393-25b7-4114-9c71-5840ee8bad84 2022-05-02 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66715-5759-2 66715575902 3 POUCH in 1 CARTON (66715-5759-2) > 2 TABLET in 1 POUCH 3 pouch 2019-10-15 2022-12-03 No No Current