FDA.reportPublic FDA data

basic care loperamide hydrochloride

Product NDC
72288-224
11-digit product format
722880224
Labeler code
72288
Product ID
72288-224_732edad8-9a3f-4ce0-a323-c8bffa4acb5f
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA075232
Marketing category
ANDA
Marketing start
2021-02-16
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
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 42.

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
A075232-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063f01610625f2…
2019-09-15 20:21 UTC2019-09A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
basic care loperamide hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
978010Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
732edad8-9a3f-4ce0-a323-c8bffa4acb5fAvailable 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
72288-224-62basic care loperamide hydrochloride24 in 1 CARTONTABLET, FILM COATED241
72288-224-62basic care loperamide hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-224BASIC CARE LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) TABLET, FILM COATED [AMAZON.COM SERVICES LLC]1Current NDC, Legacy NDC, 2 package rows20210224_732edad8-9a3f-4ce0-a323-c8bffa4acb5f.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
anti diarrhealLOPERAMIDE HCLCVS Pharmacy68467222-c8b4-4029-a180-59a57d0090d32026-08-19WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
Good Sense anti diarrhealLOPERAMIDE HYDROCHLORIDEL. Perrigo Company9c1d811d-f8d0-418c-aaf7-7b6477deea202026-05-20WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
berkley and jensen anti diarrhealLOPERAMIDE HYDROCHLORIDEBJWCdc29a8e9-f916-49d2-b9a6-d2b4537d7b582026-05-08WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
anti diarrhealLOPERAMIDE HCLWalgreen Company6e0dfbb3-6c58-40fc-83b4-09ee10576ae52026-03-01WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
Good Sense anti diarrhealLOPERAMIDE HYDROCHLORIDEPreferred Pharmaceuticals Inc.803f492d-183d-423f-b05c-48f06dc9f2a52026-01-19WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
anti diarrhealLOPERAMIDE HYDROCHLORIDEHyVee Inc9434cefe-6b13-47c4-b2f7-b8d566c5a4ff2026-01-13WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
Good Sense anti diarrhealLOPERAMIDE HYDROCHLORIDENorthwind Health Company, LLCdb47cc0a-e301-0310-e053-2a95a90a7f5d2026-01-01WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
anti diarrhealLOPERAMIDE HYDROCHLORIDEPublix Super Markets Inc44773392-eac8-48b3-ae46-b27f5fe55d8d2025-12-28WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
CareOne Diarrhea ControlLOPERAMIDE HCLAmerican Sales Company17569b2c-38f9-43bd-87ac-eb82b64866e62025-12-17WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
topcare anti diarrhealLOPERAMIDE HYDROCHLORIDETopco Associates LLCda347b47-d8a5-4cf9-9579-79e6fe57fed52025-12-13WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
anti diarrhealLOPERAMIDE HYDROCHLORIDEMajor Pharmaceuticalsbe8f1c7d-fd4e-48d4-80b0-1d92a2ba6a702025-12-06WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
Imodium A-DLOPERAMIDE HYDROCHLORIDEKenvue Brands LLC01da76d0-1979-4c45-9d39-c72ae4e4ffe22025-09-23WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
Leader Anti DiarrhealLOPERAMIDE HCLCardinal Health 110, LLC. dba Leader9079a59b-a158-4e77-a104-547959f7ba782025-07-18WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
Up and Up anti diarrhealLOPERAMIDE HYDROCHLORIDETarget Corporationddb70e85-168e-451a-ac04-f6a46721a5572025-06-02WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
anti diarrhealLOPERAMIDE HYDROCHLORIDERedpharm Drug Incf4c23673-056e-7608-e053-2995a90a92762025-01-23WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
Anti DiarrhealLOPERAMIDE HCLH E B8ecbfd81-fe45-49b4-b835-a32192de8f532024-12-02WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
dg health anti diarrhealLOPERAMIDE HYDROCHLORIDEDolgencorp, LLCcac9e7e9-fb3a-497e-866d-347530ba4dfd2024-11-11WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
injoy diarrhea reliefLOPERAMIDE HCLL. Perrigo Companycf5ccdf8-ab27-429f-a1b4-c51ced0210462024-08-12WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
anti diarrhealLOPERAMIDE HYDROCHLORIDEMeijer Distribution Inc06a0530b-b06a-466b-b366-82a2a9f7c05c2024-06-19WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232
foster and thrive anti diarrhealLOPERAMIDE HCLStrategic Sourcing Services LLC6f70564a-4400-4ed0-960b-09135a2f3a7c2023-12-07WarningsExact identifier
application applno (ANDA): 075232
application number: ANDA075232

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN732edad8-9a3f-4ce0-a323-c8bffa4acb5f1
978010loperamide hydrochloride 2 MG Oral TabletSCD732edad8-9a3f-4ce0-a323-c8bffa4acb5f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-224-627228802246224 BLISTER PACK in 1 CARTON (72288-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2021-02-160000-00-00NoNoCurrent