Home NDC 70518-2945-0 Permethrin
Product NDC 70518-2945
Requested package NDC 70518-2945-0
11-digit product format 705182945
Labeler code 70518
Product ID 70518-2945_4ab97b94-fb1e-2d2e-e063-6294a90a11ec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Permethrin Cream 5% w/w
Dosage form CREAM
Route TOPICAL
Labeler REMEDYREPACK INC.
Application ANDA211303
Marketing category ANDA
Marketing start 2019-04-08
Substance PERMETHRIN
Active strength 50 mg/g
Pharmacologic classes Pyrethrins [CS], Pyrethroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-2945 70518-2945-0 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-2945 70518-2945-0 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-2945 70518-2945-0 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…
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 A211303-001 PERMETHRIN PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211303-001 AB
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 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211303-001 PERMETHRIN 5% CREAM / TOPICAL AB 2019-04-03 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Permethrin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PERMETHRIN 50 mg/g
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106387 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-2945-0 Permethrin 60 g in 1 TUBE CREAM 60 13 70518-2945-0 Permethrin 1 in 1 CARTON CREAM 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-2945 PERMETHRIN (PERMETHRIN CREAM 5% W/W) CREAM [REMEDYREPACK INC.] 9 Current NDC, Legacy NDC, 2 package rows 20250406_e3d77092-dad6-4df5-ac39-ff9dc8f5758c.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-2945-0 70518294500 1 TUBE in 1 CARTON (70518-2945-0) / 60 g in 1 TUBE 1 tube 2019-04-08 0000-00-00 No No Current