TRETINOIN

Product NDC: 0574-2205
11-digit product format: 005742205
Labeler code: 0574
Product ID: 0574-2205_a25193b8-414f-4dfc-8ddc-8c5f92758279
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tretinoin
Dosage form: CREAM
Route: TOPICAL
Labeler: Padagis US LLC
Application: ANDA075265
Marketing category: ANDA
Marketing start: 2017-04-26
Substance: TRETINOIN
Active strength: .5 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075265-001	TRETINOIN	TRETINOIN	0.05%	CREAM / TOPICAL	AB1		1998-12-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075265-001	AB1

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075265-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075265-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075265-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075265-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075265-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075265-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075265-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075265-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075265-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075265-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075265-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075265-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075265-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075265-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075265-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075265-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075265-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075265-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075265-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075265-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075265-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075265-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075265-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075265-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075265-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075265-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075265-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075265-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075265-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075265-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075265-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075265-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075265-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075265-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075265-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075265-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075265-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075265-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075265-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075265-001	AB1	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRETINOIN	.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5688UTC01R	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
4889c7f8-37d0-4f1a-9829-bca107806586	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60	Product name	6	20251124
1426d8f8-b7d5-4053-8554-613df00c0d86	Product name	2	20250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ec	Product name	2	20250521
e3af9708-3004-7392-4046-5311eaa8bab5	Product name	3	20221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
503b047e-e62d-4745-9011-522b13bc701b	Product name	1	20181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4	Product name	2	20170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572	Product name	2	20150818
0a8118e4-08c6-b395-9ddc-d3e425e0493a	Product name	1	20140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579	Product name	1	20140508
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0574-2205-20	TRETINOIN	20 g in 1 TUBE	CREAM	20	18
0574-2205-20	TRETINOIN	1 in 1 CARTON	CREAM	1	18
0574-2205-45	TRETINOIN	1 in 1 CARTON	CREAM	1	18
0574-2205-45	TRETINOIN	45 g in 1 TUBE	CREAM	45	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-2205-20	GM - Gram	0574-2205	dabbcaea-ec4b-46da-9b7c-2d4079b47dd4	1	2017-06-15
0574-2205-45	GM - Gram	0574-2205	f3ab1a4a-b27c-4e49-8036-642288a85abc	1	2017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0574-2205	TRETINOIN GEL TRETINOIN CREAM [PADAGIS US LLC]	18	Current NDC, Legacy NDC, 4 package rows	20250202_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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRETINOIN	TRETINOIN	Bryant Ranch Prepack	8929196c-389a-4c43-843c-00fbb26a1dd9	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075265 application number: ANDA075265
TRETINOIN	TRETINOIN	A-S Medication Solutions	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075265 application number: ANDA075265
TRETINOIN	TRETINOIN	Padagis US LLC	4889c7f8-37d0-4f1a-9829-bca107806586	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075265 application number: ANDA075265 ndc (product): 0574-2205

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5688UTC01R	TRETINOIN	302-79-4	TRETINOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106303	tretinoin 0.05 % Topical Cream	PSN	8929196c-389a-4c43-843c-00fbb26a1dd9	103
106303	tretinoin 0.5 MG/ML Topical Cream	SCD	8929196c-389a-4c43-843c-00fbb26a1dd9	103
106303	tretinoin 0.05 % Topical Cream	SY	8929196c-389a-4c43-843c-00fbb26a1dd9	103
106302	tretinoin 0.025 % Topical Cream	PSN	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	24
106303	tretinoin 0.05 % Topical Cream	PSN	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	24
198300	tretinoin 0.1 % Topical Cream	PSN	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	24
106302	tretinoin 0.25 MG/ML Topical Cream	SCD	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	24
106303	tretinoin 0.5 MG/ML Topical Cream	SCD	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	24
198300	tretinoin 1 MG/ML Topical Cream	SCD	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	24
106302	tretinoin 0.025 % Topical Cream	SY	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	24
106303	tretinoin 0.05 % Topical Cream	SY	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	24
198300	tretinoin 0.1 % Topical Cream	SY	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	24
313450	tretinoin 0.01 % Topical Gel	PSN	4889c7f8-37d0-4f1a-9829-bca107806586	18
106302	tretinoin 0.025 % Topical Cream	PSN	4889c7f8-37d0-4f1a-9829-bca107806586	18
313451	tretinoin 0.025 % Topical Gel	PSN	4889c7f8-37d0-4f1a-9829-bca107806586	18
106303	tretinoin 0.05 % Topical Cream	PSN	4889c7f8-37d0-4f1a-9829-bca107806586	18
198300	tretinoin 0.1 % Topical Cream	PSN	4889c7f8-37d0-4f1a-9829-bca107806586	18
313450	tretinoin 0.0001 MG/MG Topical Gel	SCD	4889c7f8-37d0-4f1a-9829-bca107806586	18
313451	tretinoin 0.00025 MG/MG Topical Gel	SCD	4889c7f8-37d0-4f1a-9829-bca107806586	18
106302	tretinoin 0.25 MG/ML Topical Cream	SCD	4889c7f8-37d0-4f1a-9829-bca107806586	18
106303	tretinoin 0.5 MG/ML Topical Cream	SCD	4889c7f8-37d0-4f1a-9829-bca107806586	18
198300	tretinoin 1 MG/ML Topical Cream	SCD	4889c7f8-37d0-4f1a-9829-bca107806586	18
313450	tretinoin 0.01 % Topical Gel	SY	4889c7f8-37d0-4f1a-9829-bca107806586	18
106302	tretinoin 0.025 % Topical Cream	SY	4889c7f8-37d0-4f1a-9829-bca107806586	18
313451	tretinoin 0.025 % Topical Gel	SY	4889c7f8-37d0-4f1a-9829-bca107806586	18
106303	tretinoin 0.05 % Topical Cream	SY	4889c7f8-37d0-4f1a-9829-bca107806586	18
198300	tretinoin 0.1 % Topical Cream	SY	4889c7f8-37d0-4f1a-9829-bca107806586	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0574-2205-20	00574220520	1 TUBE in 1 CARTON (0574-2205-20) / 20 g in 1 TUBE	1 tube	2017-05-05	0000-00-00	No	No	Current
0574-2205-45	00574220545	1 TUBE in 1 CARTON (0574-2205-45) / 45 g in 1 TUBE	1 tube	2017-04-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tretinoin Gel, USP and Tretinoin Cream, USP	Bryant Ranch Prepack	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	103
Tretinoin Gel, USP and Tretinoin Cream, USP	A-S Medication Solutions	2024-01-28	HUMAN PRESCRIPTION DRUG LABEL	24
Tretinoin Gel, USP and Tretinoin Cream, USP	Padagis US LLC	2023-12-31	HUMAN PRESCRIPTION DRUG LABEL	19
Tretinoin Gel, USP and Tretinoin Cream, USP	Preferred Pharmaceuticals Inc.	2019-04-11	HUMAN PRESCRIPTION DRUG LABEL	2