Lice Treatment

Product NDC
42254-065
11-digit product format
422540065
Labeler code
42254
Product ID
42254-065_6efbbff4-db09-4d9d-93dd-6b6ce9271514
Type
HUMAN OTC DRUG
Nonproprietary name
permethrin
Dosage form
LOTION
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA075014
Marketing category
ANDA
Marketing start
2010-03-28
Marketing end
0000-00-00
Substance
PERMETHRIN
Active strength
1 mg/100mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct42254-065IInactivated by FDA2026-08-11
excluded packagepackage42254-06542254-065-60IInactivated by FDA2026-08-11

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 · 44 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 packagepackage42254-065-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42254-065-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42254-065-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42254-065-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42254-065-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42254-065-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42254-065-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42254-065-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42254-065-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42254-065-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42254-065-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42254-065-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42254-065-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42254-065-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42254-065-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42254-065-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42254-065-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42254-065-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42254-065-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42254-065-60e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42254-065-609bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42254-065-60110d247fa046…a55b01930146…

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
A075014-001PERMETHRINPERMETHRIN1%LOTION / TOPICAL2000-03-28

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 UTC2026-02A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f33e3e13-1328-47a9-3012-134a14fcb6a1Product name220190703

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-065-602019-09-24C16284748780-19350213a-3c0e-c013-e053-90daa90a1393Permethrin Lotion 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-065-60Lice Treatment59 mL in 1 BOTTLELOTION591
42254-065-60Lice Treatment1 in 1 CARTONLOTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-065-60ML - Milliliter42254-065f5364ac9-206e-473e-bad0-1d6c46d359ce12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-065LICE TREATMENT (PERMETHRIN) LOTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120411_6efbbff4-db09-4d9d-93dd-6b6ce9271514.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250387permethrin 1 % Medicated ShampooPSN6efbbff4-db09-4d9d-93dd-6b6ce92715141
250387permethrin 10 MG/ML Medicated ShampooSCD6efbbff4-db09-4d9d-93dd-6b6ce92715141
250387permethrin 1 % Medicated ShampooSY6efbbff4-db09-4d9d-93dd-6b6ce92715141
250387permethrin 1 % Topical LotionSY6efbbff4-db09-4d9d-93dd-6b6ce92715141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-065-604225400656059 mL in 1 BOTTLE59 mlHistorical