Permethrin

Product NDC
43598-481
11-digit product format
435980481
Labeler code
43598
Product ID
43598-481_a03706ac-cebe-15d3-b663-5bf8d79b300d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Permethrin
Dosage form
CREAM
Route
TOPICAL
Labeler
Dr. Reddy's Laboratories, Inc.
Application
ANDA209732
Marketing category
ANDA
Marketing start
2026-08-26
Substance
PERMETHRIN
Active strength
50 mg/100g
Pharmacologic classes
Pyrethrins [CS], Pyrethroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209732-001PERMETHRINPERMETHRIN5%CREAM / TOPICALAB2023-08-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209732-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209732-001PERMETHRIN5%CREAM / TOPICALAB2023-08-0184e616aacf4f…
2026-08-18 06:07:402026-07A209732-001PERMETHRIN5%CREAM / TOPICALAB2023-08-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-018072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209732-001PERMETHRIN5%CREAM / TOPICAL2023-08-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209732-001PERMETHRIN5%CREAM / TOPICALAB2023-08-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209732-001PERMETHRIN5%CREAM / TOPICALAB2023-08-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209732-001PERMETHRIN5%CREAM / TOPICALAB2023-08-019b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209732-001PERMETHRIN5%CREAM / TOPICALAB2023-08-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209732-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A209732-001AB1caaa826d4ba7…
2023-12-20 04:57 UTC2023-12A209732-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209732-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209732-001AB19b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209732-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Permethrin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PERMETHRIN50 mg/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31de941a-d5b9-8de5-6695-daca8b57d010Available on FDA.report

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PermethrinPERMETHRINDr. Reddy's Laboratories, Inc.31de941a-d5b9-8de5-6695-daca8b57d0102026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209732
application number: ANDA209732
ndc (product): 43598-481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-481-60435980481601 TUBE in 1 CARTON (43598-481-60) / 60 g in 1 TUBE1 tube2026-08-26NoNoCurrent