sunmark lice treatment

Product NDC
49348-150
11-digit product format
493480150
Labeler code
49348
Product ID
49348-150_832d576d-33f3-439f-a580-355fd63bc8d6
Type
HUMAN OTC DRUG
Nonproprietary name
Permethrin
Dosage form
LOTION
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA076090
Marketing category
ANDA
Marketing start
2015-08-03
Marketing end
0000-00-00
Substance
PERMETHRIN
Active strength
1 mg/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct49348-150DDiscontinued by firm2026-08-11
excluded packagepackage49348-15049348-150-78DDiscontinued by firm2026-08-11

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 · 18 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 packagepackage49348-150-78d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-150-78f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49348-150-782ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49348-150-78a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49348-150-78cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49348-150-78cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49348-150-78302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49348-150-78ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49348-150-780efc9e666f02…f202fb6c5f17…

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
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 · 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 UTC2026-02A076090-001PERMETHRIN1%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…
2022-09-29 23:25 UTC2022-09A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
f33e3e13-1328-47a9-3012-134a14fcb6a1Product name220190703
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-150-78ML - Milliliter49348-1503c67c72e-8857-46fb-8466-cee0e3cac95312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PERMETHRINACTIVE INGREDIENT509F88P9SZSUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
PERMETHRINACTIVE MOIETY509F88P9SZSUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
BALSAM FIR LEAFY TWIGINACTIVE INGREDIENTH1TFV1454ZSUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8SUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
CETETH-10INACTIVE INGREDIENTLF9X1PN3XJSUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39SUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302SUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
STEARALKONIUM CHLORIDEINACTIVE INGREDIENT0OUO26BB88SUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK LICE TREATMENT (PERMETHRIN) LOTION [MCKESSON]1

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250387permethrin 1 % Medicated ShampooPSN2b06f503-def4-4aaf-986b-72cf08a9b87b1
250387permethrin 10 MG/ML Medicated ShampooSCD2b06f503-def4-4aaf-986b-72cf08a9b87b1
250387permethrin 1 % Medicated ShampooSY2b06f503-def4-4aaf-986b-72cf08a9b87b1
250387permethrin 1 % Topical LotionSY2b06f503-def4-4aaf-986b-72cf08a9b87b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-150-78493480150781 BOTTLE in 1 CARTON (49348-150-78) > 59 mL in 1 BOTTLE1 bottle2015-08-030000-00-00NoNoCurrent