Topcare lice killing creme rinse

Product NDC
36800-629
11-digit product format
368000629
Labeler code
36800
Product ID
36800-629_ed4f8790-6cfe-4de9-9193-401908cbdd4d
Type
HUMAN OTC DRUG
Nonproprietary name
Permethrin
Dosage form
LOTION
Route
TOPICAL
Labeler
Topco Associates LLC
Application
ANDA076090
Marketing category
ANDA
Marketing start
2020-01-31
Substance
PERMETHRIN
Active strength
1 mg/100mL
Pharmacologic classes
Pyrethrins [CS], Pyrethroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare lice killing creme rinse
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PERMETHRIN1 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii509F88P9SZ

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-629-26Topcare lice killing creme rinse59 mL in 1 BOTTLELOTION592
36800-629-26Topcare lice killing creme rinse2 in 1 CARTONLOTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-629TOPCARE LICE KILLING CREME RINSE (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 2 package rows20200206_3b4146a6-7c54-4dd0-9388-1e38491d16f3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-629-26368000629262 BOTTLE in 1 CARTON (36800-629-26) / 59 mL in 1 BOTTLE2 bottle2020-01-310000-00-00NoNoCurrent