FDA.reportPublic FDA data

Loperamide Hydrochloride and Simethicone

Product NDC
55319-052
11-digit product format
553190052
Labeler code
55319
Product ID
55319-052_dfa3e363-cb7c-4f7a-9404-04f70312ab53
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride and Simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Family Dollar Stores, LLC
Application
ANDA211059
Marketing category
ANDA
Marketing start
2023-08-11
Substance
LOPERAMIDE HYDROCHLORIDE; DIMETHICONE
Active strength
2; 125 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONELOPERAMIDE HYDROCHLORIDE; SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-1484e616aacf4f…
2026-08-18 06:07:402026-07A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-144b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-145aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14a50c72e98297…

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
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1
DIMETHICONE125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
77TI35393CInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
978001Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f86d2c23-c43a-4190-e053-6394a90a95ccAvailable 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
55319-052-75Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63
55319-052-75Loperamide Hydrochloride and Simethicone2 in 1 CARTONTABLET23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-052LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLET [FAMILY DOLLAR STORES, LLC]3Current NDC, 2 package rows20250112_f86d2c23-c43a-4190-e053-6394a90a95cc.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEAurohealth LLCd388f536-704a-4d6e-ab27-c1a96e9394132026-05-05WarningsExact identifier
application applno (ANDA): 211059
application number: ANDA211059
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEAurohealth LLC769e3cc0-6be9-4ab6-88e1-08803d698ef72025-01-07WarningsExact identifier
application applno (ANDA): 211059
application number: ANDA211059
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEWALMART INC.12940c3b-dc58-31fb-e063-6294a90ae8802025-01-07WarningsExact identifier
application applno (ANDA): 211059
application number: ANDA211059
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEBetter Living Brands, LLCfad9a144-6d1e-be06-e053-6394a90a870c2025-01-07WarningsExact identifier
application applno (ANDA): 211059
application number: ANDA211059
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONENORTHEAST PHARMAd106d8e5-cdbb-4f90-8456-e692ffe7f4e62025-01-07WarningsExact identifier
application applno (ANDA): 211059
application number: ANDA211059
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEFamily Dollar Stores, LLCf86d2c23-c43a-4190-e053-6394a90a95cc2025-01-07WarningsExact identifier
application applno (ANDA): 211059
application number: ANDA211059
ndc (product): 55319-052
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEWALGREEN CO.e22b6c3c-3547-b507-e053-2995a90a714f2025-01-07WarningsExact identifier
application applno (ANDA): 211059
application number: ANDA211059
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEAurohealth LLC9dd3a6d6-9fff-45b3-8e76-57bf5ee2e07f2025-01-07WarningsExact identifier
application applno (ANDA): 211059
application number: ANDA211059

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSNf86d2c23-c43a-4190-e053-6394a90a95cc3
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCDf86d2c23-c43a-4190-e053-6394a90a95cc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-052-75553190052752 BLISTER PACK in 1 CARTON (55319-052-75) / 6 TABLET in 1 BLISTER PACK2 blister pack2023-08-11NoNoCurrent