Home NDC 24338-185 Sklice
Product NDC 24338-185
11-digit product format 243380185
Labeler code 24338
Product ID 24338-185_1cffeadd-3121-7ab7-e063-6394a90a2975
Type HUMAN OTC DRUG
Nonproprietary name ivermectin
Dosage form LOTION
Route TOPICAL
Labeler Azurity Pharmaceuticals
Application NDA202736
Marketing category NDA
Marketing start 2022-08-31
Substance IVERMECTIN
Active strength 5 mg/g
Pharmacologic classes Antiparasitic [EPC], Pediculicide [EPC]
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202736-001 SKLICE IVERMECTIN 0.5% LOTION / TOPICAL RLD, RS 2012-02-07
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202736-001 SKLICE 0.5% LOTION / TOPICAL AB RLD, RS 2012-02-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2020-11-12 02:37 UTC 2020-11 N202736-001 AB 1 c0c555d07b60…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N202736-001 8791153 2027-10-12 Drug product 2014-08-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202736-001 8927595 2027-10-12 U-1782 2015-12-17 74a2ff9319b5…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202736-001 8791153 2027-10-12 Drug product, Delist requested 2014-08-27 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202736-001 8927595 2027-10-12 U-1782 Delist requested 2015-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202736-001 8791153 2027-10-12 Drug product, Delist requested 2014-08-27 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202736-001 8927595 2027-10-12 U-1782 Delist requested 2015-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202736-001 8791153 2027-10-12 Drug product, Delist requested 2014-08-27 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202736-001 8927595 2027-10-12 U-1782 Delist requested 2015-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202736-001 8791153 2027-10-12 Drug product 2014-08-27 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202736-001 8927595 2027-10-12 U-1782 2015-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202736-001 8791153 2027-10-12 Drug product 2014-08-27 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202736-001 8927595 2027-10-12 U-1782 2015-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202736-001 8791153 2027-10-12 Drug product 2014-08-27 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202736-001 8927595 2027-10-12 U-1782 2015-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202736-001 8791153 2027-10-12 Drug product 2014-08-27 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202736-001 8927595 2027-10-12 U-1782 2015-12-17 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Sklice
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IVERMECTIN 5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8883YP2R6D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1246673 Internal RxNorm lookup 1298427 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 24338-185-04 Sklice 1 in 1 CARTON LOTION 1 6 24338-185-04 Sklice 117 g in 1 TUBE LOTION 117 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24338-185 SKLICE (IVERMECTIN) LOTION [AZURITY PHARMACEUTICALS] 6 Current NDC, Legacy NDC, 2 package rows 20240712_7579bdfe-a538-4bff-b7c7-df2c4b6f13db.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 24338-185-04 24338018504 1 TUBE in 1 CARTON (24338-185-04) / 117 g in 1 TUBE 1 tube 2022-08-31 0000-00-00 No No Current