Tretinoin Cream

Product NDC
62032-414
Requested package NDC
62032-414-20
11-digit product format
620320414
Labeler code
62032
Product ID
62032-414_c96be1f7-0c29-4bc7-ac51-c3da8b4788fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Obagi Cosmeceuticals LLC
Application
NDA019049
Marketing category
NDA
Marketing start
1988-09-16
Substance
TRETINOIN
Active strength
.25 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62032-41462032-414-20UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62032-41462032-414-20UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62032-41462032-414-20UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
N019049-001RETIN-ATRETINOIN0.025%CREAM / TOPICALABRLD, RS1988-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019049-001AB

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 UTC2026-02N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-163f01610625f2…
2019-09-15 20:21 UTC2019-09N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019049-001RETIN-A0.025%CREAM / TOPICALABRLD, RS1988-09-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019049-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019049-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019049-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019049-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019049-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019049-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019049-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019049-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019049-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019049-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019049-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019049-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019049-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019049-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019049-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019049-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019049-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019049-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019049-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019049-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019049-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N019049-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019049-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019049-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019049-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N019049-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019049-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019049-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019049-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019049-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019049-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019049-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019049-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019049-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019049-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019049-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019049-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019049-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019049-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019049-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Tretinoin Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5688UTC01RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
106302Internal RxNorm lookup
106303Internal RxNorm lookup
198300Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
745cc3ce-60b4-4479-a055-316817567949Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-414-202025-02-11C16284748780-12cef2736-5adc-d83d-e063-dadaa90ab31fTRETINOIN CREAM
62032-414-202025-01-30C16284748780-12cef2736-5adc-d83d-e063-dadaa90ab31fTRETINOIN CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-414-20Tretinoin Cream1 in 1 CARTONCREAM113
62032-414-20Tretinoin Cream20 g in 1 TUBECREAM2013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRETINOINACTIVE INGREDIENT5688UTC01RTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
TRETINOINACTIVE MOIETY5688UTC01RTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ITRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-414TRETINOIN CREAM (TRETINOIN) CREAM [OBAGI COSMECEUTICALS LLC]13Current NDC, Legacy NDC, 2 package rows20250213_745cc3ce-60b4-4479-a055-316817567949.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tretinoin CreamTRETINOINObagi Cosmeceuticals LLC745cc3ce-60b4-4479-a055-3168175679492025-02-11Adverse reactionsExact identifier
application applno (NDA): 019049
application number: NDA019049
ndc (package): 62032-414-20
ndc (product): 62032-414
ndc11 (package): 62032041420
TretinoinTRETINOINMylan Pharmaceuticals Inc.ba377a5e-e48a-4bd9-9d76-929d707933962024-10-09Adverse reactionsExact identifier
application applno (NDA): 019049
application number: NDA019049
Retin-ATRETINOINBausch Health US, LLC9556d73d-c573-4e0a-9feb-764ce2d1107b2024-05-17Adverse reactionsExact identifier
application applno (NDA): 019049
application number: NDA019049

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSN745cc3ce-60b4-4479-a055-31681756794913
106303tretinoin 0.05 % Topical CreamPSN745cc3ce-60b4-4479-a055-31681756794913
198300tretinoin 0.1 % Topical CreamPSN745cc3ce-60b4-4479-a055-31681756794913
106302tretinoin 0.25 MG/ML Topical CreamSCD745cc3ce-60b4-4479-a055-31681756794913
106303tretinoin 0.5 MG/ML Topical CreamSCD745cc3ce-60b4-4479-a055-31681756794913
198300tretinoin 1 MG/ML Topical CreamSCD745cc3ce-60b4-4479-a055-31681756794913
106302tretinoin 0.025 % Topical CreamSY745cc3ce-60b4-4479-a055-31681756794913
106303tretinoin 0.05 % Topical CreamSY745cc3ce-60b4-4479-a055-31681756794913
198300tretinoin 0.1 % Topical CreamSY745cc3ce-60b4-4479-a055-31681756794913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62032-414-20620320414201 TUBE in 1 CARTON (62032-414-20) / 20 g in 1 TUBE1 tube1988-09-160000-00-00NoNoCurrent