TRETINOIN

Product NDC
0574-2225
Requested package NDC
0574-2225-45
11-digit product format
005742225
Labeler code
0574
Product ID
0574-2225_a25193b8-414f-4dfc-8ddc-8c5f92758279
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis US LLC
Application
ANDA075264
Marketing category
ANDA
Marketing start
2017-06-15
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

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
A075264-001TRETINOINTRETINOIN0.025%CREAM / TOPICALAB1998-12-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075264-001AB

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 UTC2026-02A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-243f01610625f2…
2019-09-15 20:21 UTC2019-09A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075264-001TRETINOIN0.025%CREAM / TOPICALAB1998-12-24cb3db0bc1861…

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 UTC2026-02A075264-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075264-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075264-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075264-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075264-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075264-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075264-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075264-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075264-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075264-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075264-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075264-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075264-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075264-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075264-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075264-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075264-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075264-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075264-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075264-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075264-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075264-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075264-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075264-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075264-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075264-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075264-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075264-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075264-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075264-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075264-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075264-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075264-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075264-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075264-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075264-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075264-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075264-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075264-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075264-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
TRETINOIN
Listing expiration
2027-12-31

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4889c7f8-37d0-4f1a-9829-bca107806586Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-2225-20TRETINOIN1 in 1 CARTONCREAM118
0574-2225-20TRETINOIN20 g in 1 TUBECREAM2018
0574-2225-45TRETINOIN1 in 1 CARTONCREAM118
0574-2225-45TRETINOIN45 g in 1 TUBECREAM4518

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-2225-20GM - Gram0574-222594bbec7b-9382-4b0d-831b-a66819af5c3c12017-07-07
0574-2225-45GM - Gram0574-2225ff46a3a2-3a91-450f-9bde-160384e15e6012017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-2225TRETINOIN GEL TRETINOIN CREAM [PADAGIS US LLC]18Current NDC, Legacy NDC, 4 package rows20250202_4889c7f8-37d0-4f1a-9829-bca107806586.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRETINOINTRETINOINPreferred Pharmaceuticals Inc.d6819051-4748-479e-8b53-c298edcbd4102026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075264
application number: ANDA075264
TRETINOINTRETINOINNuCare Pharmaceuticals,Inc.47fc341b-8cff-9d63-e063-6394a90abdfd2026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075264
application number: ANDA075264
TRETINOINTRETINOINBryant Ranch Prepack5e84c976-d4d6-4d8f-a448-8afb47e2fbff2024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075264
application number: ANDA075264
TRETINOINTRETINOINA-S Medication Solutions0a6722ba-c2e5-4d7a-82ea-bcd6a54033b52024-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075264
application number: ANDA075264
TRETINOINTRETINOINPadagis US LLC4889c7f8-37d0-4f1a-9829-bca1078065862023-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075264
application number: ANDA075264
ndc (package): 0574-2225-45
ndc (product): 0574-2225
ndc11 (package): 00574222545

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSN5e84c976-d4d6-4d8f-a448-8afb47e2fbff102
106302tretinoin 0.25 MG/ML Topical CreamSCD5e84c976-d4d6-4d8f-a448-8afb47e2fbff102
106302tretinoin 0.025 % Topical CreamSY5e84c976-d4d6-4d8f-a448-8afb47e2fbff102
106302tretinoin 0.025 % Topical CreamPSN0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106303tretinoin 0.05 % Topical CreamPSN0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
198300tretinoin 0.1 % Topical CreamPSN0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106302tretinoin 0.25 MG/ML Topical CreamSCD0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106303tretinoin 0.5 MG/ML Topical CreamSCD0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
198300tretinoin 1 MG/ML Topical CreamSCD0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106302tretinoin 0.025 % Topical CreamSY0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106303tretinoin 0.05 % Topical CreamSY0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
198300tretinoin 0.1 % Topical CreamSY0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
313450tretinoin 0.01 % Topical GelPSN4889c7f8-37d0-4f1a-9829-bca10780658618
106302tretinoin 0.025 % Topical CreamPSN4889c7f8-37d0-4f1a-9829-bca10780658618
313451tretinoin 0.025 % Topical GelPSN4889c7f8-37d0-4f1a-9829-bca10780658618
106303tretinoin 0.05 % Topical CreamPSN4889c7f8-37d0-4f1a-9829-bca10780658618
198300tretinoin 0.1 % Topical CreamPSN4889c7f8-37d0-4f1a-9829-bca10780658618
313450tretinoin 0.0001 MG/MG Topical GelSCD4889c7f8-37d0-4f1a-9829-bca10780658618
313451tretinoin 0.00025 MG/MG Topical GelSCD4889c7f8-37d0-4f1a-9829-bca10780658618
106302tretinoin 0.25 MG/ML Topical CreamSCD4889c7f8-37d0-4f1a-9829-bca10780658618
106303tretinoin 0.5 MG/ML Topical CreamSCD4889c7f8-37d0-4f1a-9829-bca10780658618
198300tretinoin 1 MG/ML Topical CreamSCD4889c7f8-37d0-4f1a-9829-bca10780658618
313450tretinoin 0.01 % Topical GelSY4889c7f8-37d0-4f1a-9829-bca10780658618
106302tretinoin 0.025 % Topical CreamSY4889c7f8-37d0-4f1a-9829-bca10780658618
313451tretinoin 0.025 % Topical GelSY4889c7f8-37d0-4f1a-9829-bca10780658618
106303tretinoin 0.05 % Topical CreamSY4889c7f8-37d0-4f1a-9829-bca10780658618
198300tretinoin 0.1 % Topical CreamSY4889c7f8-37d0-4f1a-9829-bca10780658618
106302tretinoin 0.025 % Topical CreamPSN47fc341b-8cff-9d63-e063-6394a90abdfd1
106302tretinoin 0.025 % Topical CreamPSNd6819051-4748-479e-8b53-c298edcbd4101
106302tretinoin 0.025 % Topical CreamPSNb1bfadb8-2622-4eb1-b69e-477c4ed82c6a1
106302tretinoin 0.25 MG/ML Topical CreamSCDd6819051-4748-479e-8b53-c298edcbd4101
106302tretinoin 0.25 MG/ML Topical CreamSCDb1bfadb8-2622-4eb1-b69e-477c4ed82c6a1
106302tretinoin 0.25 MG/ML Topical CreamSCD47fc341b-8cff-9d63-e063-6394a90abdfd1
106302tretinoin 0.025 % Topical CreamSYb1bfadb8-2622-4eb1-b69e-477c4ed82c6a1
106302tretinoin 0.025 % Topical CreamSY47fc341b-8cff-9d63-e063-6394a90abdfd1
106302tretinoin 0.025 % Topical CreamSYd6819051-4748-479e-8b53-c298edcbd4101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-2225-45005742225451 TUBE in 1 CARTON (0574-2225-45) / 45 g in 1 TUBE1 tube2017-06-150000-00-00NoNoCurrent