FDA.reportPublic FDA data

Loperamide Hydrochloride and Simethicone

Product NDC
69230-325
Requested package NDC
69230-325-06
11-digit product format
692300325
Labeler code
69230
Product ID
69230-325_e875c38b-493f-1f9f-e053-2995a90a6cd1
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride and Simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Camber Consumer Care Inc
Application
ANDA211438
Marketing category
ANDA
Marketing start
2021-06-17
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
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
2026-09-14 22:38:342026-08A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-1784e616aacf4f…
2026-08-18 06:07:402026-07A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-174b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211438-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-06-17a50c72e98297…

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
e2a4af66-1d05-408c-9f11-f2a9f325d75cAvailable 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
69230-325-04Loperamide Hydrochloride and Simethicone4 in 1 BLISTER PACKTABLET43
69230-325-04Loperamide Hydrochloride and Simethicone1 in 1 CARTONTABLET13
69230-325-06Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63
69230-325-06Loperamide Hydrochloride and Simethicone1 in 1 CARTONTABLET13
69230-325-08Loperamide Hydrochloride and Simethicone4 in 1 BLISTER PACKTABLET43
69230-325-08Loperamide Hydrochloride and Simethicone2 in 1 CARTONTABLET23
69230-325-12Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63
69230-325-12Loperamide Hydrochloride and Simethicone2 in 1 CARTONTABLET23
69230-325-18Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63
69230-325-18Loperamide Hydrochloride and Simethicone3 in 1 CARTONTABLET33
69230-325-24Loperamide Hydrochloride and Simethicone4 in 1 CARTONTABLET43
69230-325-24Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-325-12EA - Each69230-32522efe18e-340c-4822-ac6b-7106f3c2dad112021-10-08
69230-325-24EA - Each69230-325beeb7395-3a5f-4743-b07a-ba5073b45b2012021-10-08
69230-325-32EA - Each69230-325a5d2c93e-f48c-4327-b177-03eef10a11a712021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-325LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE) TABLET [CAMBER CONSUMER CARE INC]3Current NDC, Legacy NDC, 12 package rows20220913_e2a4af66-1d05-408c-9f11-f2a9f325d75c.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 · 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
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
ndc (package): 69230-325-06
ndc (product): 69230-325
ndc11 (package): 69230032506

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSNe2a4af66-1d05-408c-9f11-f2a9f325d75c3
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCDe2a4af66-1d05-408c-9f11-f2a9f325d75c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-325-06692300325061 BLISTER PACK in 1 CARTON (69230-325-06) / 6 TABLET in 1 BLISTER PACK1 blister pack2021-06-170000-00-00NoNoCurrent