Home NDC 84441-713 Loperamide Hydrochloride and Simethicone
Product NDC 84441-713
11-digit product format 844410713
Labeler code 84441
Product ID 84441-713_41d6dba5-e412-c8d2-e063-6294a90ae8fa
Type HUMAN OTC DRUG
Nonproprietary name Loperamide Hydrochloride and Simethicone
Dosage form TABLET
Route ORAL
Labeler IMO-GEN LABS LLC
Application ANDA211438
Marketing category ANDA
Marketing start 2025-10-23
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE LOPERAMIDE HYDROCHLORIDE; SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17
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.
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 2026-09-14 22:38:34 2026-08 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211438-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2021-06-17 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Loperamide Hydrochloride and Simethicone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 125 mg/1 LOPERAMIDE HYDROCHLORIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup 77TI35393C 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 84441-713-10 Loperamide Hydrochloride and Simethicone 100 in 1 BOTTLE TABLET 100 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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84441-713-10 84441071310 100 TABLET in 1 BOTTLE (84441-713-10) 100 tablet 2025-10-23 No No Current