Ivermectin

Product NDC: 0574-2107
11-digit product format: 005742107
Labeler code: 0574
Product ID: 0574-2107_63c19d12-bc86-42b6-a16e-33b773b3c05e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IVERMECTIN
Dosage form: CREAM
Route: TOPICAL
Labeler: Padagis US LLC
Application: NDA206255
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2021-06-07
Marketing end: 0000-00-00
Substance: IVERMECTIN
Active strength: 10 mg/g
Pharmacologic classes: Antiparasitic [EPC], Pediculicide [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0574-2107		D	Discontinued by firm		2026-08-10
excluded package	package	0574-2107	0574-2107-45	D	Discontinued by firm		2026-08-10

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0574-2107		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0574-2107	0574-2107-45	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N206255-001	SOOLANTRA	IVERMECTIN	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N206255-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N206255-001	10206939	2034-03-13	U-1631	2019-02-19
N206255-001	9089587	2034-03-13	U-1631	2015-07-31
N206255-001	9233117	2034-03-13	U-1631	2016-01-19
N206255-001	9233118	2034-03-13	U-1631	2016-01-19
N206255-001	9782425	2034-03-13	U-1631	2018-01-05

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL		RLD, RS	2014-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL		RLD, RS	2014-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206255-001	SOOLANTRA	1%	CREAM / TOPICAL	AB	RLD, RS	2014-12-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206255-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206255-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206255-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206255-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206255-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206255-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206255-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206255-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206255-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206255-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206255-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206255-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206255-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206255-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206255-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206255-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206255-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206255-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206255-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206255-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206255-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206255-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206255-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206255-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206255-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206255-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206255-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206255-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206255-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206255-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206255-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206255-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206255-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206255-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206255-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 446 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206255-001	10206939	2034-03-13	U-1631		2019-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206255-001	9089587	2034-03-13	U-1631		2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206255-001	9233117	2034-03-13	U-1631		2016-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206255-001	9233118	2034-03-13	U-1631		2016-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206255-001	9782425	2034-03-13	U-1631		2018-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	10206939	2034-03-13	U-1631		2019-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	9089587	2034-03-13	U-1631		2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	9233117	2034-03-13	U-1631		2016-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	9233118	2034-03-13	U-1631		2016-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206255-001	9782425	2034-03-13	U-1631		2018-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206255-001	10206939	2034-03-13	U-1631		2019-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206255-001	9089587	2034-03-13	U-1631		2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206255-001	9233117	2034-03-13	U-1631		2016-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206255-001	9233118	2034-03-13	U-1631		2016-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206255-001	9782425	2034-03-13	U-1631		2018-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	10206939	2034-03-13	U-1631		2019-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	9089587	2034-03-13	U-1631		2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	9233117	2034-03-13	U-1631		2016-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	9233118	2034-03-13	U-1631		2016-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206255-001	9782425	2034-03-13	U-1631		2018-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	10206939	2034-03-13	U-1631		2019-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	9089587	2034-03-13	U-1631		2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	9233117	2034-03-13	U-1631		2016-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	9233118	2034-03-13	U-1631		2016-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206255-001	9782425	2034-03-13	U-1631		2018-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	11033565	2024-04-22		Drug product	2021-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	7550440	2024-04-22	U-1631	Drug product	2015-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	8080530	2024-04-22	U-1631	Drug product	2015-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	8093219	2024-04-22	U-1631	Drug product	2015-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	8415311	2024-04-22	U-1631	Drug product	2015-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	8470788	2024-04-22	U-1631	Drug product	2015-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	8815816	2024-04-22	U-1631	Drug product	2015-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	10206939	2034-03-13	U-1631		2019-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	9089587	2034-03-13	U-1631		2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	9233117	2034-03-13	U-1631		2016-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	9233118	2034-03-13	U-1631		2016-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206255-001	9782425	2034-03-13	U-1631		2018-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206255-001	11033565	2024-04-22		Drug product	2021-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206255-001	7550440	2024-04-22	U-1631	Drug product	2015-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206255-001	8080530	2024-04-22	U-1631	Drug product	2015-01-20	`2680178bc6a6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-2107-45	GM - Gram	0574-2107	db743cef-4a79-4697-bcdd-aeafcc25b850	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0574-2107	IVERMECTIN CREAM [PADAGIS US LLC]	4	Legacy NDC	20230306_bd0bb2c2-3bc2-4672-9dc1-9ee9b5d70140.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOOLANTRA	IVERMECTIN	Galderma Laboratories, L.P.	b1d5b166-ab06-4ab5-b0c6-31126238118a	2024-10-24	Adverse reactions	Exact identifier application applno (NDA): 206255 application number: NDA206255
IVERMECTIN	IVERMECTIN	Mayne Pharma Inc.	39fbf2b3-cd2f-4e04-99c4-ca4390fae2bd	2023-08-29	Adverse reactions	Exact identifier application applno (NDA): 206255 application number: NDA206255

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8883YP2R6D	IVERMECTIN	70288-86-7	IVERMECTIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0574-2107-45	00574210745	1 TUBE in 1 CARTON (0574-2107-45) > 45 g in 1 TUBE	1 tube	2021-06-07	0000-00-00	No	No	Current