Home NDC 45802-269 Permethrin
Product NDC 45802-269
11-digit product format 458020269
Labeler code 45802
Product ID 45802-269_94cb7331-7eb8-412e-b8f5-662d6671332c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Permethrin
Dosage form CREAM
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application ANDA076369
Marketing category ANDA
Marketing start 2006-08-11
Substance PERMETHRIN
Active strength 50 mg/g
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 A076369-001 PERMETHRIN PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076369-001 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 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB 2003-04-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB 2003-04-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB 2003-04-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB 2003-04-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076369-001 PERMETHRIN 5% CREAM / TOPICAL AB RS 2003-04-21 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 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45802-269-37 Permethrin 60 g in 1 TUBE CREAM 60 10 45802-269-37 Permethrin 1 in 1 CARTON CREAM 1 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PERMETHRIN ACTIVE INGREDIENT 509F88P9SZ PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 PERMETHRIN ACTIVE MOIETY 509F88P9SZ PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT HHT01ZNK31 PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 CETETH-20 INACTIVE INGREDIENT I835H2IHHX PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 FORMALDEHYDE INACTIVE INGREDIENT 1HG84L3525 PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 LANOLIN ALCOHOLS INACTIVE INGREDIENT 884C3FA9HE PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R PERMETHRIN CREAM [PERRIGO NEW YORK INC] 4 PERMETHRIN ACTIVE INGREDIENT 509F88P9SZ PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 PERMETHRIN ACTIVE INGREDIENT 509F88P9SZ PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 Permethrin ACTIVE INGREDIENT 509F88P9SZ PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP] 1 PERMETHRIN ACTIVE MOIETY 509F88P9SZ PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 Permethrin ACTIVE MOIETY 509F88P9SZ PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP] 1 PERMETHRIN ACTIVE MOIETY 509F88P9SZ PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 CARBOMER 934 INACTIVE INGREDIENT Z135WT9208 PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP] 1 CARBOMER HOMOPOLYMER TYPE B INACTIVE INGREDIENT HHT01ZNK31 PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 CARBOMER HOMOPOLYMER TYPE B/C (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 4Q93RCW27E PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 CETEARETH-25 INACTIVE INGREDIENT 8FA93U5T67 PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP] 1 CETETH-20 INACTIVE INGREDIENT I835H2IHHX PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 CETETH-20 INACTIVE INGREDIENT I835H2IHHX PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 FORMALDEHYDE INACTIVE INGREDIENT 1HG84L3525 PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 FORMALDEHYDE INACTIVE INGREDIENT 1HG84L3525 PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 LANOLIN ALCOHOLS INACTIVE INGREDIENT 884C3FA9HE PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP] 1 LANOLIN ALCOHOLS INACTIVE INGREDIENT 884C3FA9HE PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 LANOLIN ALCOHOLS INACTIVE INGREDIENT 884C3FA9HE PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PERMETHRIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-269 PERMETHRIN CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] 10 Current NDC, Legacy NDC, 2 package rows 20250302_bdb796aa-a7d1-4476-988f-2b4a9519788f.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 45802-269-37 45802026937 1 TUBE in 1 CARTON (45802-269-37) / 60 g in 1 TUBE 1 tube 2006-08-11 0000-00-00 No No Current