Renova

Product NDC
42254-165
11-digit product format
422540165
Labeler code
42254
Product ID
42254-165_21cfe6a3-03b9-42f5-8f7f-111c56fe3c59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
NDA021108
Marketing category
NDA
Marketing start
2011-10-18
Marketing end
0000-00-00
Substance
TRETINOIN
Active strength
0 mg/g
Pharmacologic classes
Retinoid [EPC],Retinoids [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42254-165IInactivated by FDA2026-08-03
excluded packagepackage42254-16542254-165-40IInactivated by FDA2026-08-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42254-165-40d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42254-165-40f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42254-165-402ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42254-165-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42254-165-40cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42254-165-40cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42254-165-40302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42254-165-40ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42254-165-400efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42254-165-40ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42254-165-40367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42254-165-40557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42254-165-408af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42254-165-40834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42254-165-401332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42254-165-40fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42254-165-4086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42254-165-40bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42254-165-408dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42254-165-40e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42254-165-409bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42254-165-40110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021108-001RENOVATRETINOIN0.02%CREAM / TOPICALRLD, RS2000-08-31

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-313f01610625f2…
2019-09-15 20:21 UTC2019-09N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31b00525d2431f…
2019-07-19 19:46 UTC2019-07N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-313f0d92c62455…
2023-05-13 08:27 UTC2023-05N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31053a50430f4f…
2023-01-26 05:58 UTC2023-01N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021108-001RENOVA0.02%CREAM / TOPICALRLD, RS2000-08-31cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021108-00165311412020-03-0774a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021108-00165311412020-03-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021108-00165311412020-03-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021108-00165311412020-03-073f01610625f2…
2019-09-15 20:21 UTC2019-09N021108-00165311412020-03-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N021108-00165311412020-03-07ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-165-402019-09-24C16284748780-19350213a-3df7-c013-e053-90daa90a1393RENOVA ® (TRETINOIN CREAM) 0.02%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-165-40Renova40 g in 1 TUBECREAM401
42254-165-40Renova1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-165-40GM - Gram42254-1657c1fee32-0474-485e-a970-5baa2d5b6cd312012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-165RENOVA (TRETINOIN) CREAM [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120420_21cfe6a3-03b9-42f5-8f7f-111c56fe3c59.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RenovaTRETINOINBausch Health US LLC9f0a0e8d-1051-48a4-80c5-1bd260dd9c362026-02-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 021108
application number: NDA021108

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
846955RENOVA 0.02 % Topical CreamPSN21cfe6a3-03b9-42f5-8f7f-111c56fe3c591
252265tretinoin 0.02 % Topical CreamPSN21cfe6a3-03b9-42f5-8f7f-111c56fe3c591
846955tretinoin 0.2 MG/ML Topical Cream [Renova]SBD21cfe6a3-03b9-42f5-8f7f-111c56fe3c591
252265tretinoin 0.2 MG/ML Topical CreamSCD21cfe6a3-03b9-42f5-8f7f-111c56fe3c591
846955Renova 0.02 % Topical CreamSY21cfe6a3-03b9-42f5-8f7f-111c56fe3c591
846955Renova 0.2 MG/ML Topical CreamSY21cfe6a3-03b9-42f5-8f7f-111c56fe3c591
252265tretinoin 0.02 % Topical CreamSY21cfe6a3-03b9-42f5-8f7f-111c56fe3c591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-165-404225401654040 g in 1 TUBE40 gHistorical