Home NDC 41250-375-55 anti diarrheal plus anti gas
Product NDC 41250-375
Requested package NDC 41250-375-55
11-digit product format 412500375
Labeler code 41250
Product ID 41250-375_ea6fe67a-827f-48ec-a1f7-9c619b04d8c4
Type HUMAN OTC DRUG
Nonproprietary name loperamide hydrochloride, simethicone
Dosage form TABLET
Route ORAL
Labeler Meijer Distribution Inc
Application ANDA209837
Marketing category ANDA
Marketing start 2018-10-16
Substance DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Active strength 125; 2 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE LOPERAMIDE HYDROCHLORIDE; SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05
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 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209837-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2018-09-05 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base anti diarrheal plus anti gas
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOPERAMIDE HYDROCHLORIDE 125 mg/1 DIMETHICONE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 77TI35393C Internal UNII lookup 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 978001 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41250-375-55 anti diarrheal plus anti gas 42 in 1 BOTTLE TABLET 42 5 41250-375-55 anti diarrheal plus anti gas 1 in 1 CARTON TABLET 1 5 41250-375-62 anti diarrheal plus anti gas 1 in 1 BLISTER PACK TABLET 1 5 41250-375-62 anti diarrheal plus anti gas 24 in 1 CARTON TABLET 24 5 41250-375-65 anti diarrheal plus anti gas 30 in 1 BOTTLE TABLET 30 5 41250-375-65 anti diarrheal plus anti gas 1 in 1 CARTON TABLET 1 5 41250-375-89 anti diarrheal plus anti gas 18 in 1 CARTON TABLET 18 5 41250-375-89 anti diarrheal plus anti gas 1 in 1 BLISTER PACK TABLET 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41250-375 ANTI DIARRHEAL PLUS ANTI GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [MEIJER DISTRIBUTION INC] 5 Current NDC, Legacy NDC, 8 package rows 20240713_e2c9a752-618a-4e34-89a5-671aab4013ac.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 · 17 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join good sense anti diarrheal anti gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE L. Perrigo Company 2cda08a8-3f5e-430c-84a3-d29b97d647af 2026-05-20 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 CareOne Diarrhea and Gas Control LOPERAMIDE HYDROCHLORIDE, SIMETHICONE American Sales Company dfa3db5a-cef6-4ed5-b9f1-a20b6d1657b3 2026-04-21 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 anti diarrheal anti gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE HyVee Inc 396ea4f5-5c3d-4cbc-acd5-09eb64c806e0 2026-03-02 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 anti diarrheal anti gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE H E B 35cff261-932e-4b2e-ab21-80969c27fa92 2025-06-27 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 good neighbor pharmacy anti diarrheal anti gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE Amerisource Bergen 5dae1247-3ec0-495e-b3f2-1c1555141617 2025-04-08 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 Anti Diarrheal Anti Gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE Kroger Company 9c7db942-c8cb-493a-a96f-452b8dfebfc6 2024-07-23 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 signature care anti diarrheal anti gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE Safeway 53829e72-d22c-434d-a108-1972081a6efb 2024-07-22 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 anti diarrheal and anti gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE Walgreen Company 0999243a-c3be-41a6-b327-962e63d8c356 2024-07-22 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 dg health anti diarrheal anti gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE Dolgencorp, LLC 09798231-39cd-49b2-9be5-ea51e52f0a6d 2024-07-22 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 Basic Care Loperamide Hydrochloride and Simethicone LOPERAMIDE HYDROCHLORIDE, SIMETHICONE Amazon.com Services LLC aa79234e-1fbd-4279-b4b1-46b4f041b4e8 2024-07-22 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 equaline anti diarrheal plus anti gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE United Natural Foods, Inc. dba UNFI 2ce0b37e-6dc4-423f-a1d6-a2cb623946d5 2024-07-22 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 up and up anti diarrheal anti gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE Target Corporation ef75085c-95df-4901-9c97-069fcfc3eef7 2024-07-22 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 anti diarrheal anti gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE Rite Aid Corporation 8e954f86-bc15-45e2-9274-ca5d8a7c9687 2024-07-22 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 anti diarrheal and anti gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE CVS Pharmacy 065699b5-217e-432f-a253-cea2d3f62233 2024-07-20 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 Good Sense Anti Diarrheal Anti Gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE L. Perrigo Company fcfd0b64-6876-4e6f-8a7b-ca1da9e03f00 2024-07-13 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 anti diarrheal plus anti gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE Meijer Distribution Inc e2c9a752-618a-4e34-89a5-671aab4013ac 2024-07-11 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837 ndc (package): 41250-375-55 ndc (product): 41250-375 ndc11 (package): 41250037555 foster and thrive anti diarrheal anti gas LOPERAMIDE HYDROCHLORIDE, SIMETHICONE Strategic Sourcing Services LLC 9132dc1c-8e16-4236-881e-863f5e57f0ab 2024-07-08 Warnings Exact identifier application applno (ANDA): 209837 application number: ANDA209837
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41250-375-55 41250037555 1 BOTTLE in 1 CARTON (41250-375-55) > 42 TABLET in 1 BOTTLE 1 bottle 2018-10-16 0000-00-00 No No Current