Permethrin

Product NDC: 16714-897
Requested package NDC: 16714-897-01
11-digit product format: 167140897
Labeler code: 16714
Product ID: 16714-897_5f6533d8-cd32-44e6-964f-d1087530172c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Permethrin
Dosage form: CREAM
Route: TOPICAL
Labeler: Northstar Rx LLC
Application: ANDA076369
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 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076369-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076369-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076369-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076369-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076369-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076369-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076369-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076369-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076369-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076369-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076369-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076369-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076369-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076369-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076369-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076369-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076369-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076369-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076369-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076369-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076369-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076369-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076369-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076369-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076369-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076369-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076369-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076369-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076369-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076369-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076369-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076369-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076369-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076369-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076369-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076369-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076369-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076369-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076369-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076369-001	AB	1	`f41ea6bd6efb…`

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: 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
11e91140-cf12-42de-9f4a-cdbc22e74658	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f33e3e13-1328-47a9-3012-134a14fcb6a1	Product name	2	20190703

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16714-897-01	Permethrin	60 g in 1 TUBE	CREAM	60		6
16714-897-01	Permethrin	1 in 1 CONTAINER	CREAM	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-897-01	GM - Gram	16714-897	c474ffa1-8671-4d2d-9a65-436a3f119a19	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-897	PERMETHRIN CREAM [NORTHSTAR RX LLC]	6	Current NDC, Legacy NDC, 2 package rows	20250519_11e91140-cf12-42de-9f4a-cdbc22e74658.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Permethrin	PERMETHRIN	Bryant Ranch Prepack	850414a5-a261-40ac-999e-cdcbd23c0cb0	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076369 application number: ANDA076369
Permethrin	PERMETHRIN	Bryant Ranch Prepack	f4af5093-2e4a-43c6-b585-4bb14f73f370	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076369 application number: ANDA076369
Permethrin	PERMETHRIN	Northstar Rx LLC	11e91140-cf12-42de-9f4a-cdbc22e74658	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076369 application number: ANDA076369 ndc (package): 16714-897-01 ndc (product): 16714-897 ndc11 (package): 16714089701
Permethrin	PERMETHRIN	Padagis Israel Pharmaceuticals Ltd	bdb796aa-a7d1-4476-988f-2b4a9519788f	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076369 application number: ANDA076369

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
509F88P9SZ	PERMETHRIN	52645-53-1	PERMETHRIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106387	permethrin 5 % Topical Cream	PSN	11e91140-cf12-42de-9f4a-cdbc22e74658	6
106387	permethrin 50 MG/ML Topical Cream	SCD	11e91140-cf12-42de-9f4a-cdbc22e74658	6
106387	permethrin 5 % Topical Cream	SY	11e91140-cf12-42de-9f4a-cdbc22e74658	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-897-01	16714089701	1 TUBE in 1 CONTAINER (16714-897-01) / 60 g in 1 TUBE	1 tube	2019-04-08	0000-00-00	No	No	Current