Zyclara

Product NDC: 99207-270
11-digit product format: 992070270
Labeler code: 99207
Product ID: 99207-270_1216e839-274f-412d-953f-ce56f0cd42a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: imiquimod
Dosage form: CREAM
Route: TOPICAL
Labeler: Bausch Health US, LLC
Application: NDA022483
Marketing category: NDA
Marketing start: 2011-11-28
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: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	99207-270	99207-270-28	D	Discontinued by firm		2026-08-03

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
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product	99207-270		UNFINISHED	Active or certified unfinished drug listing		unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	99207-270	99207-270-12	UNFINISHED	Active or certified unfinished drug listing		unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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: Zyclara
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
967017	Internal RxNorm lookup
967021	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
28cd9b5b-680b-480f-b33d-9c5b52bbf03d	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
99207-270-01	Zyclara	0.25 g in 1 PACKET	CREAM	0.25	23
99207-270-01	Zyclara	4 in 1 CARTON	CREAM	4	23
99207-270-28	Zyclara	28 in 1 CARTON	CREAM	28	23
99207-270-28	Zyclara	0.25 g in 1 PACKET	CREAM	0.25	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
99207-270-28	EA - Each	99207-270	42f34826-40f7-4043-9fe9-8f37b63f5742	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
imiquimod	ACTIVE INGREDIENT	P1QW714R7M	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7
imiquimod	ACTIVE MOIETY	P1QW714R7M	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7
ISOSTEARIC ACID	INACTIVE INGREDIENT	X33R8U0062	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
99207-270	ZYCLARA (IMIQUIMOD) CREAM [BAUSCH HEALTH US, LLC]	22	Current NDC, Legacy NDC, 4 package rows	20250525_28cd9b5b-680b-480f-b33d-9c5b52bbf03d.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
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 ndc (product): 99207-270

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	28cd9b5b-680b-480f-b33d-9c5b52bbf03d	23
967021	Zyclara 3.75 % Topical Cream	PSN	28cd9b5b-680b-480f-b33d-9c5b52bbf03d	23
967021	imiquimod 37.5 MG/ML Topical Cream [Zyclara]	SBD	28cd9b5b-680b-480f-b33d-9c5b52bbf03d	23
967017	imiquimod 37.5 MG/ML Topical Cream	SCD	28cd9b5b-680b-480f-b33d-9c5b52bbf03d	23
967017	imiquimod 3.75 % Topical Cream	SY	28cd9b5b-680b-480f-b33d-9c5b52bbf03d	23
967021	Zyclara 3.75 % Topical Cream	SY	28cd9b5b-680b-480f-b33d-9c5b52bbf03d	23
967021	Zyclara 37.5 MG/ML Topical Cream	SY	28cd9b5b-680b-480f-b33d-9c5b52bbf03d	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
99207-270-01	99207027001	4 PACKET in 1 CARTON (99207-270-01) / .25 g in 1 PACKET	4 packet	2011-11-28	0000-00-00	No	No	Current
99207-270-28	99207027028	28 PACKET in 1 CARTON (99207-270-28) > .25 g in 1 PACKET	28 packet	2011-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zyclara	Bausch Health US, LLC \| Kindeva Drug Delivery Limited \| Bausch Health Companies Inc.	2025-05-23	HUMAN PRESCRIPTION DRUG LABEL	23