Permethrin

Product NDC
21695-907
11-digit product format
216950907
Labeler code
21695
Product ID
21695-907_aa294be5-9015-4f6a-8a92-a71a2b22d1b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Permethrin
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA076369
Marketing category
ANDA
Marketing start
2003-04-21
Marketing end
0000-00-00
Substance
PERMETHRIN
Active strength
50 mg/g
Pharmacologic classes
Pyrethrins [CS],Pyrethroid [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-907IInactivated by FDA2026-08-11
excluded packagepackage21695-90721695-907-60IInactivated by FDA2026-08-11

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-907-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-907-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-907-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-907-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-907-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-907-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-907-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-907-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-907-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-907-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-907-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-907-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-907-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-907-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-907-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-907-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-907-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-907-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-907-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-907-60e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-907-609bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-907-60110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076369-001PERMETHRINPERMETHRIN5%CREAM / TOPICALABRS2003-04-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076369-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076369-001PERMETHRIN5%CREAM / TOPICALAB2003-04-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076369-001PERMETHRIN5%CREAM / TOPICALAB2003-04-213f01610625f2…
2019-09-15 20:21 UTC2019-09A076369-001PERMETHRIN5%CREAM / TOPICALAB2003-04-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A076369-001PERMETHRIN5%CREAM / TOPICALAB2003-04-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076369-001PERMETHRIN5%CREAM / TOPICALABRS2003-04-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076369-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076369-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076369-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076369-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076369-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076369-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076369-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076369-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076369-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076369-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076369-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076369-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076369-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076369-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076369-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076369-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076369-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076369-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076369-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076369-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076369-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076369-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076369-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076369-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076369-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076369-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076369-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076369-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076369-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076369-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076369-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076369-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076369-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076369-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076369-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076369-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076369-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076369-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076369-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076369-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f33e3e13-1328-47a9-3012-134a14fcb6a1Product name220190703

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-907-602019-09-24C16284748780-1934fe258-4bcf-48b1-e053-8cdaa90a720aPermethrin Cream,5% w/w

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-907-60Permethrin60 g in 1 TUBECREAM601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-907-60GM - Gram21695-9076cc7076b-ead6-4bd8-937c-41c32df10a9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PermethrinACTIVE INGREDIENT509F88P9SZPERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1
PermethrinACTIVE MOIETY509F88P9SZPERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KPERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1
CETEARETH-25INACTIVE INGREDIENT8FA93U5T67PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXPERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSPERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEPERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UPERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IPERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RPERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-907PERMETHRIN CREAM [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101119_aa294be5-9015-4f6a-8a92-a71a2b22d1b2.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PermethrinPERMETHRINBryant Ranch Prepack850414a5-a261-40ac-999e-cdcbd23c0cb02025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076369
application number: ANDA076369
PermethrinPERMETHRINBryant Ranch Prepackf4af5093-2e4a-43c6-b585-4bb14f73f3702025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076369
application number: ANDA076369
PermethrinPERMETHRINNorthstar Rx LLC11e91140-cf12-42de-9f4a-cdbc22e746582025-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076369
application number: ANDA076369
PermethrinPERMETHRINPadagis Israel Pharmaceuticals Ltdbdb796aa-a7d1-4476-988f-2b4a9519788f2023-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076369
application number: ANDA076369

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106387permethrin 5 % Topical CreamPSNaa294be5-9015-4f6a-8a92-a71a2b22d1b21
106387permethrin 50 MG/ML Topical CreamSCDaa294be5-9015-4f6a-8a92-a71a2b22d1b21
106387permethrin 5 % Topical CreamSYaa294be5-9015-4f6a-8a92-a71a2b22d1b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-907-602169509076060 g in 1 TUBE60 gHistorical