lice treatment

Product NDC
11822-0549
Requested package NDC
11822-0549-1
11-digit product format
118220549
Labeler code
11822
Product ID
11822-0549_fededd3d-42a5-4b86-af2f-0fa1a4601fc8
Type
HUMAN OTC DRUG
Nonproprietary name
Permethrin
Dosage form
LOTION
Route
TOPICAL
Labeler
Rite Aid Corporation
Application
ANDA076090
Marketing category
ANDA
Marketing start
2011-01-26
Marketing end
0000-00-00
Substance
PERMETHRIN
Active strength
1 mg/100mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-054911822-0549-1DDiscontinued by firm2026-09-14

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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
A076090-001PERMETHRINPERMETHRIN1%LOTION / TOPICAL2001-12-20

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 22:38:342026-08A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-2084e616aacf4f…
2026-08-18 06:07:402026-07A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-203f01610625f2…
2019-09-15 20:21 UTC2019-09A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PERMETHRINACTIVE INGREDIENT509F88P9SZLICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
PERMETHRINACTIVE MOIETY509F88P9SZLICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
BALSAM FIR LEAFY TWIGINACTIVE INGREDIENTH1TFV1454ZLICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8LICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
CETETH-10INACTIVE INGREDIENTLF9X1PN3XJLICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
ETHYLPARABENINACTIVE INGREDIENT14255EXE39LICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TLICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
STEARALKONIUM CHLORIDEINACTIVE INGREDIENT0OUO26BB88LICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RLICE TREATMENT (PERMETHRIN) LOTION [RITE AID CORPORATION]2

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense lice killing creme rinsePERMETHRINL. Perrigo Company056fb377-34dd-4d33-83d7-c895b105f5742022-11-21WarningsExact identifier
application applno (ANDA): 076090
application number: ANDA076090
Topcare lice killing creme rinsePERMETHRINTopco Associates LLC3b4146a6-7c54-4dd0-9388-1e38491d16f32020-01-31WarningsExact identifier
application applno (ANDA): 076090
application number: ANDA076090

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0549-1118220549012 BOTTLE in 1 CARTON (11822-0549-1) > 59 mL in 1 BOTTLE2 bottle2011-01-260000-00-00NoNoCurrent