good neighbor pharmacy loperamide hydrochloride

Product NDC
17856-0545
11-digit product format
178560545
Labeler code
17856
Product ID
17856-0545_e550f322-8b22-40e9-9fdd-77ded2f741df
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA091292
Marketing category
ANDA
Marketing start
2018-08-13
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/7.5mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-0545IInactivated by FDA2026-10-12
excluded packagepackage17856-054517856-0545-1IInactivated by FDA2026-10-12
excluded packagepackage17856-054517856-0545-2IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0545-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0545-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0545-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0545-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0545-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0545-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0545-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0545-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-0545-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-0545-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-0545-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-0545-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0545-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0545-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0545-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0545-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0545-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0545-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-0545-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-0545-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-0545-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-0545-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-0545-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-0545-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17856-0545-28af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17856-0545-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-0545-2834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-0545-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0545-21332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0545-11332a3947898…d4bfe170f9cd…

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
A091292-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2011-05-20

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2011-05-2084e616aacf4f…
2026-08-18 06:07:402026-07A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2011-05-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2011-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSOLUTION / ORAL2011-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-203f01610625f2…
2019-09-15 20:21 UTC2019-09A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091292-001LOPERAMIDE HYDROCHLORIDE1MG/7.5MLSUSPENSION / ORAL2011-05-20f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0545-1good neighbor pharmacy loperamide hydrochloride15 mL in 1 CUP, UNIT-DOSESOLUTION152
17856-0545-1good neighbor pharmacy loperamide hydrochloride50 in 1 BOX, UNIT-DOSESOLUTION502
17856-0545-2good neighbor pharmacy loperamide hydrochloride7.5 mL in 1 CUP, UNIT-DOSESOLUTION7.52
17856-0545-2good neighbor pharmacy loperamide hydrochloride72 in 1 BOX, UNIT-DOSESOLUTION722

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0545-1ML - Milliliter17856-0545b6f4eb35-2a10-46ad-adf4-372d8ae2b92112022-11-07
17856-0545-2ML - Milliliter17856-054562baeed5-389f-401b-9773-992a94d3f58812020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0545GOOD NEIGHBOR PHARMACY LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [ATLANTIC BIOLOGICALS CORP.]2Legacy NDC, 4 package rows20210124_c923b712-e269-4270-bba7-972010febe83.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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
anti diarrhealLOPERAMIDE HCLH E B01964f8a-f05c-4f72-9530-e0cffd981ffa2025-04-11WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
good neighbor pharmacy loperamide hydrochlorideLOPERAMIDE HCLAmerisource Bergen53f66b4a-b97b-4995-b2cf-e33afe996af12025-04-11WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
Anti DiarrhealLOPERAMIDE HCLWalgreen Companyf70d0568-27c0-4c63-8d68-82e31b87174f2025-04-11WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
basic care loperamide hydrochlorideLOPERAMIDE HCLAmazon.com Services LLCd6b8015c-f8fe-45cb-891f-566fb319b46b2025-04-03WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
topcare loperamide hydrochlorideLOPERAMIDE HCLTopco Associates LLC1cd497b4-d97e-447a-9251-710d2fddbf232025-04-01WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
anti-diarrhealLOPERAMIDE HYDROCHLORIDESafeway9d0c565f-64a2-4300-b1e2-5dee9546ea142024-10-22WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292
loperamide hydrochlorideLOPERAMIDE HCLRite Aid Corporation56334ed4-8cb0-4f5c-9051-6836f0e213372024-06-28WarningsExact identifier
application applno (ANDA): 091292
application number: ANDA091292

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSNc923b712-e269-4270-bba7-972010febe832
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCDc923b712-e269-4270-bba7-972010febe832
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSYc923b712-e269-4270-bba7-972010febe832
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSYc923b712-e269-4270-bba7-972010febe832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0545-11785605450150 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0545-1) > 15 mL in 1 CUP, UNIT-DOSE2021-01-220000-00-00NoNoCurrent
17856-0545-21785605450272 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0545-2) > 7.5 mL in 1 CUP, UNIT-DOSE2021-01-220000-00-00NoNoCurrent