FDA.reportPublic FDA data

Loperamide Hydrochloride and Simethicone

Product NDC
84441-713
Requested package NDC
84441-713-10
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 1.

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
A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONELOPERAMIDE HYDROCHLORIDE; SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEIMO-GEN LABS LLC41d6dba5-e411-c8d2-e063-6294a90ae8fa2025-10-23WarningsExact identifier
application applno (ANDA): 211438
application number: ANDA211438
ndc (package): 84441-713-10
ndc (product): 84441-713
ndc11 (package): 84441071310
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEFSA store INC0199a50f-f367-40e7-8af0-745a959d3fde2025-04-05WarningsExact identifier
application applno (ANDA): 211438
application number: ANDA211438
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONECamber Consumer Care Ince2a4af66-1d05-408c-9f11-f2a9f325d75c2022-09-12WarningsExact identifier
application applno (ANDA): 211438
application number: ANDA211438

Additional Listing Data#

Finished product
Yes
Brand name base
Loperamide Hydrochloride and Simethicone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 mg/1
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup
77TI35393CInternal 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
41d6dba5-e411-c8d2-e063-6294a90ae8faAvailable 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
84441-713-10Loperamide Hydrochloride and Simethicone100 in 1 BOTTLETABLET1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN41d6dba5-e411-c8d2-e063-6294a90ae8fa1
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD41d6dba5-e411-c8d2-e063-6294a90ae8fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84441-713-1084441071310100 TABLET in 1 BOTTLE (84441-713-10) 100 tablet2025-10-23NoNoCurrent