Home NDC 99207-260 Aldara
Product NDC 99207-260
11-digit product format 992070260
Labeler code 99207
Product ID 99207-260_924ae7cc-ba20-4b02-b726-06069f586f46
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name imiquimod
Dosage form CREAM
Route TOPICAL
Labeler Bausch Health US LLC
Application NDA020723
Marketing category NDA
Marketing start 1997-02-27
Marketing end 0000-00-00
Substance IMIQUIMOD
Active strength 50 mg/g
Pharmacologic classes Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 33 matching rows.
View current auxiliary records. · View the auxiliary file history.
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RS Approval date N020723-001 ALDARA IMIQUIMOD 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27
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UTC 2026-02 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020723-001 ALDARA 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1997-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020723-001 ALDARA 5% CREAM / TOPICAL RLD 1997-02-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020723-001 ALDARA 5% CREAM / TOPICAL RLD 1997-02-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020723-001 ALDARA 5% CREAM / TOPICAL RLD 1997-02-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020723-001 ALDARA 5% CREAM / TOPICAL RLD 1997-02-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020723-001 ALDARA 5% CREAM / TOPICAL RLD 1997-02-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020723-001 ALDARA 5% CREAM / TOPICAL RLD 1997-02-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020723-001 ALDARA 5% CREAM / TOPICAL RLD 1997-02-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020723-001 ALDARA 5% CREAM / TOPICAL RLD 1997-02-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020723-001 ALDARA 5% CREAM / TOPICAL AB RLD, RS 1997-02-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 3 · 105 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020723-001 7696159 2024-04-01 U-1048 Drug substance 2010-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020723-001 7696159*PED 2024-10-01 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020723-001 7696159 2024-04-01 U-1048 Drug substance 2010-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020723-001 7696159*PED 2024-10-01 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020723-001 7696159 2024-04-01 U-1048 Drug substance 2010-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020723-001 7696159*PED 2024-10-01 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020723-001 7696159 2024-04-01 U-1048 Drug substance 2010-05-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020723-001 7696159*PED 2024-10-01 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020723-001 7696159 2024-04-01 U-1048 Drug substance 2010-05-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020723-001 7696159*PED 2024-10-01 Pediatric extension d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020723-001 7696159 2024-04-01 U-1048 Drug substance 2010-05-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020723-001 7696159*PED 2024-10-01 Pediatric extension 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020723-001 7696159 2024-04-01 U-1048 Drug substance 2010-05-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020723-001 7696159*PED 2024-10-01 Pediatric extension 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020723-001 7696159 2024-04-01 U-1048 Drug substance 2010-05-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020723-001 7696159*PED 2024-10-01 Pediatric extension 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020723-001 7696159 2024-04-01 U-1048 Drug substance 2010-05-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020723-001 7696159*PED 2024-10-01 Pediatric extension 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020723-001 7696159 2024-04-01 U-1048 Drug substance 2010-05-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020723-001 7696159*PED 2024-10-01 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020723-001 7696159 2024-04-01 U-1048 Drug substance 2010-05-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020723-001 7696159*PED 2024-10-01 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020723-001 7696159 2024-04-01 U-1048 Drug substance 2010-05-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020723-001 7696159*PED 2024-10-01 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020723-001 7696159 2024-04-01 U-1048 Drug substance 2010-05-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020723-001 7696159*PED 2024-10-01 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020723-001 7696159 2024-04-01 U-1047 Drug substance 2010-05-12 bb7c543d1eb4…
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 99207-260-12 99207026012 12 PACKET in 1 CARTON (99207-260-12) > .25 g in 1 PACKET 12 packet 1997-02-27 2022-06-30 No No Current