Permethrin

Product NDC
50090-5888
11-digit product format
500905888
Labeler code
50090
Product ID
50090-5888_74307089-9918-401b-a9e1-1ec6b4d56889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Permethrin 5% w/w
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211303-001PERMETHRINPERMETHRIN5%CREAM / TOPICALAB2019-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211303-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-033f01610625f2…
2019-09-15 20:21 UTC2019-09A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211303-001PERMETHRIN5%CREAM / TOPICALAB2019-04-03e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211303-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211303-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211303-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211303-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211303-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211303-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211303-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211303-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211303-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211303-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211303-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211303-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211303-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211303-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211303-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211303-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211303-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211303-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211303-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211303-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211303-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211303-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A211303-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211303-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211303-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211303-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A211303-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A211303-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211303-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211303-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211303-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211303-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211303-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211303-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211303-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211303-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211303-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211303-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211303-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211303-001AB1e64feba35796…

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
694abbf9-9460-4c55-b8c7-66220cabb5b6Available 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
50090-5888-0Permethrin60 g in 1 TUBECREAM603
50090-5888-0Permethrin1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5888-0GM - Gram50090-58887e33994c-0e21-49fe-8b16-b63fc480211012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5888PERMETHRIN (PERMETHRIN 5% W/W) CREAM [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20231125_694abbf9-9460-4c55-b8c7-66220cabb5b6.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
PermethrinPERMETHRIN CREAM 5% W/WPreferred Pharmaceuticals Inc.d0d6b1ac-2f3a-433b-ba2b-832be3e0f93f2026-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211303
application number: ANDA211303
PermethrinPERMETHRIN CREAM 5% W/WREMEDYREPACK INC.e3d77092-dad6-4df5-ac39-ff9dc8f5758c2026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211303
application number: ANDA211303
PermethrinPERMETHRIN CREAM 5% W/WEncube Ethicals, Inc.35225d0a-3bde-4c7d-bdf9-81661012e77c2025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211303
application number: ANDA211303
PermethrinPERMETHRIN 5% W/WA-S Medication Solutions694abbf9-9460-4c55-b8c7-66220cabb5b62023-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211303
application number: ANDA211303
ndc (product): 50090-5888

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106387permethrin 5 % Topical CreamPSN694abbf9-9460-4c55-b8c7-66220cabb5b63
106387permethrin 50 MG/ML Topical CreamSCD694abbf9-9460-4c55-b8c7-66220cabb5b63
106387permethrin 5 % Topical CreamSY694abbf9-9460-4c55-b8c7-66220cabb5b63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5888-0500905888001 TUBE in 1 CARTON (50090-5888-0) / 60 g in 1 TUBE1 tube2021-12-300000-00-00NoNoCurrent