FDA.reportPublic FDA data

Application 076029

Type
ANDA
Sponsor
PERRIGO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONELOPERAMIDE HYDROCHLORIDE; SIMETHICONETABLET, CHEWABLE;ORAL2MG;125MGNoYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONELOPERAMIDE HYDROCHLORIDE; SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-30

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-3084e616aacf4f…
2026-08-18 06:07:402026-07A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-303f01610625f2…
2019-09-15 20:21 UTC2019-09A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORAL2002-08-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076029-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET, CHEWABLE / ORALRS2002-08-30f41ea6bd6efb…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEAurohealth LLCd388f536-704a-4d6e-ab27-c1a96e9394132026-05-05WarningsName fallback
brand name: Loperamide Hydrochloride and Simethicone
Loperamide hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEBionpharma Inc.47a779c7-c709-6208-e063-6394a90a6dfa2026-01-05WarningsName fallback
brand name: Loperamide hydrochloride and Simethicone
Loperamide hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEBionpharma Inc.9b0a802f-6fae-4142-ad2f-4b16ed67400e2025-12-12WarningsName fallback
brand name: Loperamide hydrochloride and Simethicone
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEGranules India Ltde0c1693e-0e55-4368-a8a5-2f0882fbf9522025-12-01WarningsName fallback
brand name: Loperamide Hydrochloride and Simethicone
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEIMO-GEN LABS LLC41d6dba5-e411-c8d2-e063-6294a90ae8fa2025-10-23WarningsName fallback
brand name: Loperamide Hydrochloride and Simethicone
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEFSA store INC0199a50f-f367-40e7-8af0-745a959d3fde2025-04-05WarningsName fallback
brand name: Loperamide Hydrochloride and Simethicone
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEAurohealth LLC769e3cc0-6be9-4ab6-88e1-08803d698ef72025-01-07WarningsName fallback
brand name: Loperamide Hydrochloride and Simethicone
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEWALMART INC.12940c3b-dc58-31fb-e063-6294a90ae8802025-01-07WarningsName fallback
brand name: Loperamide Hydrochloride and Simethicone
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEBetter Living Brands, LLCfad9a144-6d1e-be06-e053-6394a90a870c2025-01-07WarningsName fallback
brand name: Loperamide Hydrochloride and Simethicone
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONENORTHEAST PHARMAd106d8e5-cdbb-4f90-8456-e692ffe7f4e62025-01-07WarningsName fallback
brand name: Loperamide Hydrochloride and Simethicone
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEFamily Dollar Stores, LLCf86d2c23-c43a-4190-e053-6394a90a95cc2025-01-07WarningsName fallback
brand name: Loperamide Hydrochloride and Simethicone
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEWALGREEN CO.e22b6c3c-3547-b507-e053-2995a90a714f2025-01-07WarningsName fallback
brand name: Loperamide Hydrochloride and Simethicone
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEAurohealth LLC9dd3a6d6-9fff-45b3-8e76-57bf5ee2e07f2025-01-07WarningsName fallback
brand name: Loperamide Hydrochloride and Simethicone
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONECamber Consumer Care Ince2a4af66-1d05-408c-9f11-f2a9f325d75c2022-09-12WarningsName fallback
brand name: Loperamide Hydrochloride and Simethicone

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.