Sklice

Product NDC
24338-183
11-digit product format
243380183
Labeler code
24338
Product ID
24338-183_1b5d3e2e-2d3c-47ab-991b-258942dcf6c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IVERMECTIN
Dosage form
LOTION
Route
TOPICAL
Labeler
Arbor Pharmaceuticals
Application
NDA202736
Marketing category
NDA
Marketing start
2016-06-30
Marketing end
0000-00-00
Substance
IVERMECTIN
Active strength
5 mg/g
Pharmacologic classes
Antiparasitic [EPC],Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct24338-183DDiscontinued by firm2026-08-03
excluded packagepackage24338-18324338-183-04DDiscontinued by firm2026-08-03

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 · 24 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 packagepackage24338-183-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage24338-183-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage24338-183-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage24338-183-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage24338-183-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage24338-183-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage24338-183-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage24338-183-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage24338-183-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage24338-183-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage24338-183-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage24338-183-04557ba5c1ecfa…9c80585c8c6e…

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
N202736-001SKLICEIVERMECTIN0.5%LOTION / TOPICALRLD, RS2012-02-07

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202736-001SKLICE0.5%LOTION / TOPICALABRLD, RS2012-02-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-073f01610625f2…
2019-09-15 20:21 UTC2019-09N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N202736-001SKLICE0.5%LOTION / TOPICALRLD, RS2012-02-07cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-11-12 02:37 UTC2020-11N202736-001AB1c0c555d07b60…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N202736-00187911532027-10-12Drug product2014-08-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202736-00189275952027-10-12U-17822015-12-1774a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202736-00187911532027-10-12Drug product, Delist requested2014-08-2787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202736-00189275952027-10-12U-1782Delist requested2015-12-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N202736-00187911532027-10-12Drug product, Delist requested2014-08-275aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N202736-00189275952027-10-12U-1782Delist requested2015-12-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202736-00187911532027-10-12Drug product, Delist requested2014-08-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202736-00189275952027-10-12U-1782Delist requested2015-12-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202736-00187911532027-10-12Drug product2014-08-27c0c555d07b60…
2020-11-12 02:37 UTC2020-11N202736-00189275952027-10-12U-17822015-12-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202736-00187911532027-10-12Drug product2014-08-273f01610625f2…
2019-12-14 00:12 UTC2019-12N202736-00189275952027-10-12U-17822015-12-173f01610625f2…
2019-09-15 20:21 UTC2019-09N202736-00187911532027-10-12Drug product2014-08-27b00525d2431f…
2019-09-15 20:21 UTC2019-09N202736-00189275952027-10-12U-17822015-12-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N202736-00187911532027-10-12Drug product2014-08-27ea99ee380514…
2019-07-19 19:46 UTC2019-07N202736-00189275952027-10-12U-17822015-12-17ea99ee380514…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SkliceIVERMECTINAzurity Pharmaceuticals7579bdfe-a538-4bff-b7c7-df2c4b6f13db2024-07-11WarningsExact identifier
application applno (NDA): 202736
application number: NDA202736