Home NDC 0299-3823 SOOLANTRA
Product NDC 0299-3823
11-digit product format 002993823
Labeler code 0299
Product ID 0299-3823_253c7c90-5d85-b1e0-e063-6394a90a7a4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IVERMECTIN
Dosage form CREAM
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application NDA206255
Marketing category NDA
Marketing start 2015-01-01
Substance IVERMECTIN
Active strength 10 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 N206255-001 SOOLANTRA IVERMECTIN 1% CREAM / TOPICAL AB RLD, RS 2014-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N206255-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206255-001 10206939 2034-03-13 U-1631 2019-02-19 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 N206255-001 9782425 2034-03-13 U-1631 2018-01-05
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 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206255-001 SOOLANTRA 1% CREAM / TOPICAL RLD, RS 2014-12-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206255-001 SOOLANTRA 1% CREAM / TOPICAL RLD, RS 2014-12-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206255-001 SOOLANTRA 1% CREAM / TOPICAL AB RLD, RS 2014-12-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 12 · 446 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206255-001 9782425 2034-03-13 U-1631 2018-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206255-001 9782425 2034-03-13 U-1631 2018-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206255-001 9782425 2034-03-13 U-1631 2018-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206255-001 9782425 2034-03-13 U-1631 2018-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206255-001 9782425 2034-03-13 U-1631 2018-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 11033565 2024-04-22 Drug product 2021-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 7550440 2024-04-22 U-1631 Drug product 2015-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 8080530 2024-04-22 U-1631 Drug product 2015-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 8093219 2024-04-22 U-1631 Drug product 2015-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 8415311 2024-04-22 U-1631 Drug product 2015-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 8470788 2024-04-22 U-1631 Drug product 2015-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 8815816 2024-04-22 U-1631 Drug product 2015-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 10206939 2034-03-13 U-1631 2019-02-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 9089587 2034-03-13 U-1631 2015-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 9233117 2034-03-13 U-1631 2016-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 9233118 2034-03-13 U-1631 2016-01-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206255-001 9782425 2034-03-13 U-1631 2018-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206255-001 11033565 2024-04-22 Drug product 2021-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206255-001 7550440 2024-04-22 U-1631 Drug product 2015-01-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206255-001 8080530 2024-04-22 U-1631 Drug product 2015-01-20 2680178bc6a6…
Additional Listing Data#
Finished product Yes
Brand name base SOOLANTRA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IVERMECTIN 10 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 1598068 Internal RxNorm lookup 1598073 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IVERMECTIN ACTIVE INGREDIENT 8883YP2R6D SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 IVERMECTIN ACTIVE MOIETY 8883YP2R6D SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 809Y72KV36 SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 ISOPROPYL PALMITATE INACTIVE INGREDIENT 8CRQ2TH63M SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 OLEYL ALCOHOL INACTIVE INGREDIENT 172F2WN8DV SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 POLYOXYL 20 CETOSTEARYL ETHER INACTIVE INGREDIENT YRC528SWUY SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-3823 SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.] 8 Current NDC, Legacy NDC, 9 package rows 20241027_b1d5b166-ab06-4ab5-b0c6-31126238118a.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 · 2 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 0299-3823-00 00299382300 2 g in 1 TUBE (0299-3823-00) 2 g 2019-11-01 0000-00-00 Yes No Current 0299-3823-02 00299382302 1 TUBE in 1 BLISTER PACK (0299-3823-02) / 2 g in 1 TUBE 1 tube 2015-01-01 0000-00-00 Yes No Current 0299-3823-30 00299382330 1 TUBE in 1 CARTON (0299-3823-30) / 30 g in 1 TUBE 1 tube 2015-01-01 0000-00-00 No No Current 0299-3823-45 00299382345 1 TUBE in 1 CARTON (0299-3823-45) / 45 g in 1 TUBE 1 tube 2015-01-01 0000-00-00 No No Current 0299-3823-60 00299382360 1 TUBE in 1 CARTON (0299-3823-60) / 60 g in 1 TUBE 1 tube 2015-01-01 0000-00-00 No No Current