Imiquimod

Product NDC: 0093-3133
Requested package NDC: 0093-3133-31
11-digit product format: 000933133
Labeler code: 0093
Product ID: 0093-3133_38cf079b-29a3-e85d-e063-6294a90aece1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: imiquimod
Dosage form: CREAM
Route: TOPICAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: NDA022483
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-07-30
Substance: IMIQUIMOD
Active strength: 37.5 mg/g
Pharmacologic classes: Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022483-001	ZYCLARA	IMIQUIMOD	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25
N022483-002	ZYCLARA	IMIQUIMOD	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022483-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022483-001	10238645	2029-08-18	U-1455	2019-04-11
N022483-001	10238645	2029-08-18	U-172	2019-04-11
N022483-001	8598196	2029-08-18	U-1455	2013-12-11
N022483-001	8598196	2029-08-18	U-172	2013-12-11
N022483-001	10238644	2029-12-11	U-68	2019-04-11
N022483-001	8236816	2029-12-11	U-68	2012-08-08
N022483-001	8299109	2029-12-11	U-68	2012-11-01
N022483-001	10918635	2030-04-30	U-1455	2021-03-03
N022483-001	10918635	2030-04-30	U-172	2021-03-03
N022483-001	11202752	2030-04-30	U-1455	2022-01-19
N022483-001	11202752	2030-04-30	U-172	2022-01-19
N022483-001	11850245	2030-04-30	U-1455	2024-01-12
N022483-001	11850245	2030-04-30	U-172	2024-01-12
N022483-002	11318130	2029-12-11	U-68	2022-05-20
N022483-002	8222270	2029-12-11	U-68	2012-07-18

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 3 · 82 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	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL		RLD, RS	2010-03-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`782e0a99824c…`

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	N022483-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022483-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022483-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022483-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022483-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022483-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022483-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022483-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022483-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022483-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022483-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022483-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022483-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022483-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022483-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022483-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022483-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022483-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022483-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022483-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022483-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022483-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022483-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022483-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022483-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022483-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022483-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022483-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022483-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022483-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022483-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022483-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022483-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022483-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 523 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022483-001	10238645	2029-08-18	U-172	2019-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	10238645	2029-08-18	U-1455	2019-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	8598196	2029-08-18	U-172	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	8598196	2029-08-18	U-1455	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	10238644	2029-12-11	U-68	2019-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	8236816	2029-12-11	U-68	2012-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	8299109	2029-12-11	U-68	2012-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	10918635	2030-04-30	U-172	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	10918635	2030-04-30	U-1455	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	11202752	2030-04-30	U-1455	2022-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	11202752	2030-04-30	U-172	2022-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	11850245	2030-04-30	U-1455	2024-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	11850245	2030-04-30	U-172	2024-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-002	11318130	2029-12-11	U-68	2022-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-002	8222270	2029-12-11	U-68	2012-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	10238645	2029-08-18	U-172	2019-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	10238645	2029-08-18	U-1455	2019-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	8598196	2029-08-18	U-172	2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	8598196	2029-08-18	U-1455	2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	10238644	2029-12-11	U-68	2019-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	8236816	2029-12-11	U-68	2012-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	8299109	2029-12-11	U-68	2012-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	10918635	2030-04-30	U-172	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	10918635	2030-04-30	U-1455	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	11202752	2030-04-30	U-1455	2022-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	11202752	2030-04-30	U-172	2022-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	11850245	2030-04-30	U-1455	2024-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	11850245	2030-04-30	U-172	2024-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-002	11318130	2029-12-11	U-68	2022-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-002	8222270	2029-12-11	U-68	2012-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022483-001	10238645	2029-08-18	U-172	2019-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	10238645	2029-08-18	U-1455	2019-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	8598196	2029-08-18	U-172	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	8598196	2029-08-18	U-1455	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	10238644	2029-12-11	U-68	2019-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	8236816	2029-12-11	U-68	2012-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	8299109	2029-12-11	U-68	2012-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	10918635	2030-04-30	U-172	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	10918635	2030-04-30	U-1455	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-001	11202752	2030-04-30	U-1455	2022-01-19	`6a471c1ec25d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IMIQUIMOD	37.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P1QW714R7M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
967017	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
9f2cbefd-f295-47e2-8a9e-3e7c5812c963	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5624e12d-8450-453b-aa8d-acacc0adf764	Product name	1	20210621
b519e8a5-29e1-d8cd-ace0-3915cc880d8f	Product name	2	20150122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-3133-31	Imiquimod	1 in 1 CARTON	CREAM	1		5
0093-3133-31	Imiquimod	7.5 g in 1 BOTTLE, PUMP	CREAM	7.5		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-3133-31	GM - Gram	0093-3133	e864efda-d801-4bcc-aa85-18dfafa41a92	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-3133	IMIQUIMOD CREAM [TEVA PHARMACEUTICALS USA, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20210427_9f2cbefd-f295-47e2-8a9e-3e7c5812c963.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imiquimod	IMIQUIMOD	Teva Pharmaceuticals USA, Inc.	9f2cbefd-f295-47e2-8a9e-3e7c5812c963	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022483 application number: NDA022483 ndc (package): 0093-3133-31 ndc (product): 0093-3133 ndc11 (package): 00093313331
Imiquimod	IMIQUIMOD	Oceanside Pharmacueticals	d86eeb0e-70e0-4c72-aaa3-37daa1d8611e	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022483 application number: NDA022483
Zyclara	IMIQUIMOD	Bausch Health US, LLC	28cd9b5b-680b-480f-b33d-9c5b52bbf03d	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022483 application number: NDA022483

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P1QW714R7M	IMIQUIMOD	99011-02-6	IMIQUIMOD

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
967017	imiquimod 3.75 % Topical Cream	PSN	9f2cbefd-f295-47e2-8a9e-3e7c5812c963	5
967017	imiquimod 37.5 MG/ML Topical Cream	SCD	9f2cbefd-f295-47e2-8a9e-3e7c5812c963	5
967017	imiquimod 3.75 % Topical Cream	SY	9f2cbefd-f295-47e2-8a9e-3e7c5812c963	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-3133-31	00093313331	1 BOTTLE, PUMP in 1 CARTON (0093-3133-31) / 7.5 g in 1 BOTTLE, PUMP	2020-07-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Imiquimod	Teva Pharmaceuticals USA, Inc. \| Bausch Health Companies Inc. \| Kindeva Drug Delivery Limited	2025-06-30	HUMAN PRESCRIPTION DRUG LABEL	5
Imiquimod	Bryant Ranch Prepack	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	102