FDA.reportPublic FDA data

Basic Care Loperamide Hydrochloride and Simethicone

Product NDC
72288-001
11-digit product format
722880001
Labeler code
72288
Product ID
72288-001_83f02c43-bcd6-4d59-8f13-d1ea5a99585c
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA209837
Marketing category
ANDA
Marketing start
2020-06-24
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
A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONELOPERAMIDE HYDROCHLORIDE; SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05a50c72e98297…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEL. Perrigo Company2cda08a8-3f5e-430c-84a3-d29b97d647af2026-05-20WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
CareOne Diarrhea and Gas ControlLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmerican Sales Companydfa3db5a-cef6-4ed5-b9f1-a20b6d1657b32026-04-21WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEHyVee Inc396ea4f5-5c3d-4cbc-acd5-09eb64c806e02026-03-02WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEH E B35cff261-932e-4b2e-ab21-80969c27fa922025-06-27WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
good neighbor pharmacy anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmerisource Bergen5dae1247-3ec0-495e-b3f2-1c15551416172025-04-08WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
Anti Diarrheal Anti GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEKroger Company9c7db942-c8cb-493a-a96f-452b8dfebfc62024-07-23WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
signature care anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONESafeway53829e72-d22c-434d-a108-1972081a6efb2024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEWalgreen Company0999243a-c3be-41a6-b327-962e63d8c3562024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
dg health anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEDolgencorp, LLC09798231-39cd-49b2-9be5-ea51e52f0a6d2024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
Basic Care Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmazon.com Services LLCaa79234e-1fbd-4279-b4b1-46b4f041b4e82024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 72288-001
equaline anti diarrheal plus anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEUnited Natural Foods, Inc. dba UNFI2ce0b37e-6dc4-423f-a1d6-a2cb623946d52024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
up and up anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONETarget Corporationef75085c-95df-4901-9c97-069fcfc3eef72024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332024-07-20WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
Good Sense Anti Diarrheal Anti GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEL. Perrigo Companyfcfd0b64-6876-4e6f-8a7b-ca1da9e03f002024-07-13WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
anti diarrheal plus anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEMeijer Distribution Ince2c9a752-618a-4e34-89a5-671aab4013ac2024-07-11WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
foster and thrive anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEStrategic Sourcing Services LLC9132dc1c-8e16-4236-881e-863f5e57f0ab2024-07-08WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE125 mg/1
DIMETHICONE2 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
aa79234e-1fbd-4279-b4b1-46b4f041b4e8Available 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
72288-001-62Basic Care Loperamide Hydrochloride and Simethicone1 in 1 BLISTER PACKTABLET13
72288-001-62Basic Care Loperamide Hydrochloride and Simethicone24 in 1 CARTONTABLET243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-001BASIC CARE LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [AMAZON.COM SERVICES LLC]3Current NDC, Legacy NDC, 2 package rows20240805_aa79234e-1fbd-4279-b4b1-46b4f041b4e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSNaa79234e-1fbd-4279-b4b1-46b4f041b4e83
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCDaa79234e-1fbd-4279-b4b1-46b4f041b4e83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-001-627228800016224 BLISTER PACK in 1 CARTON (72288-001-62) / 1 TABLET in 1 BLISTER PACK24 blister pack2020-06-240000-00-00NoNoCurrent