Permethrin

Product NDC
71335-2899
11-digit product format
713352899
Labeler code
71335
Product ID
71335-2899_8fd909af-eaa7-4364-a0e4-921f82b12b2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Permethrin
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
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-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…

Additional Listing Data#

Finished product
Yes
Brand name base
Permethrin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PERMETHRIN50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
509F88P9SZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
106387Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
850414a5-a261-40ac-999e-cdcbd23c0cb0Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2899-1Permethrin1 in 1 CARTONCREAM1100
71335-2899-1Permethrin60 g in 1 TUBECREAM60100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2899-1GM - Gram71335-28997a0708e8-f171-49a1-8d2d-642f5af7f1c012026-01-08

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
ndc (product): 71335-2899
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 CreamPSN850414a5-a261-40ac-999e-cdcbd23c0cb0100
106387permethrin 50 MG/ML Topical CreamSCD850414a5-a261-40ac-999e-cdcbd23c0cb0100
106387permethrin 5 % Topical CreamSY850414a5-a261-40ac-999e-cdcbd23c0cb0100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2899-1713352899011 TUBE in 1 CARTON (71335-2899-1) / 60 g in 1 TUBE1 tube2025-10-24NoNoCurrent