Home NDC 36800-629 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076090-001 PERMETHRIN PERMETHRIN 1% LOTION / TOPICAL 2001-12-20
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076090-001 PERMETHRIN 1% LOTION / TOPICAL 2001-12-20 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Topcare lice killing creme rinse
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PERMETHRIN 1 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 509F88P9SZ Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-629-26 Topcare lice killing creme rinse 59 mL in 1 BOTTLE LOTION 59 2 36800-629-26 Topcare lice killing creme rinse 2 in 1 CARTON LOTION 2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-629 TOPCARE LICE KILLING CREME RINSE (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC] 2 Current NDC, Legacy NDC, 2 package rows 20200206_3b4146a6-7c54-4dd0-9388-1e38491d16f3.zip
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-629-26 36800062926 2 BOTTLE in 1 CARTON (36800-629-26) / 59 mL in 1 BOTTLE 2 bottle 2020-01-31 0000-00-00 No No Current