FDA.reportPublic FDA data

Sunmark Lice Killing

Product NDC
49348-443
Requested package NDC
49348-443-34
11-digit product format
493480443
Labeler code
49348
Product ID
49348-443_dd6455b7-210a-4b74-876d-2d6d5f23503e
Type
HUMAN OTC DRUG
Nonproprietary name
Piperonyl butoxide, Pyrethrum extract
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
part358G
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-07-27
Marketing end
0000-00-00
Substance
PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT
Active strength
4 g/100mL; g/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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49348-44349348-443-34DDiscontinued by firm2026-09-09

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 · 6 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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-443-30ML - Milliliter49348-443a1bdd95a-caf1-4b9f-a403-47dcfb4e2fef12012-07-24
49348-443-34ML - Milliliter49348-4437ad2703c-a549-4f29-8c18-556c998c63a712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIPERONYL BUTOXIDEACTIVE INGREDIENTLWK91TU9AHSUNMARK LICE KILLING MAXIMUM STRENGTH LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [MCKESSON]3
PYRETHRUM EXTRACTACTIVE INGREDIENTZUM06L90GVSUNMARK LICE KILLING MAXIMUM STRENGTH LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [MCKESSON]3
PIPERONYL BUTOXIDEACTIVE MOIETYLWK91TU9AHSUNMARK LICE KILLING MAXIMUM STRENGTH LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [MCKESSON]3
PYRETHRUM EXTRACTACTIVE MOIETYZUM06L90GVSUNMARK LICE KILLING MAXIMUM STRENGTH LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [MCKESSON]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSUNMARK LICE KILLING MAXIMUM STRENGTH LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [MCKESSON]3
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70SUNMARK LICE KILLING MAXIMUM STRENGTH LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [MCKESSON]3
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK LICE KILLING MAXIMUM STRENGTH LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [MCKESSON]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESUNMARK LICE KILLING MAXIMUM STRENGTH LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [MCKESSON]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooPSNaf2db460-ea24-4092-889c-04b7068ec1022
283219piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated ShampooSCDaf2db460-ea24-4092-889c-04b7068ec1022
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooSYaf2db460-ea24-4092-889c-04b7068ec1022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-443-34493480443341 BOTTLE in 1 CARTON (49348-443-34) > 118 mL in 1 BOTTLE1 bottle2007-09-210000-00-00NoNoCurrent