Tretinoin

Product NDC: 0472-0117
Requested package NDC: 0472-0117-45
11-digit product format: 004720117
Labeler code: 0472
Product ID: 0472-0117_b99bedbe-3d36-47dd-b84c-05f8bb394b83
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tretinoin
Dosage form: CREAM
Route: TOPICAL
Labeler: Actavis Pharma, Inc.
Application: NDA020404
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1998-04-20
Marketing end: 2027-07-31
Substance: TRETINOIN
Active strength: .25 mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
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
N020404-003	AVITA	TRETINOIN	0.025%	CREAM / TOPICAL	AB		1997-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020404-003	AB

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	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020404-003	AVITA	0.025%	CREAM / TOPICAL	AB	1997-01-14	`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	N020404-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020404-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020404-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020404-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020404-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020404-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020404-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020404-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020404-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020404-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020404-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020404-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020404-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020404-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020404-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020404-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020404-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020404-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020404-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020404-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020404-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020404-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020404-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020404-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020404-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020404-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020404-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020404-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020404-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020404-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020404-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020404-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020404-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020404-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020404-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020404-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020404-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020404-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020404-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020404-003	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tretinoin

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRETINOIN	.25 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
106302	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b5e385a2-f6f9-41cb-8a33-eedba397043f	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
0472-0117-20	Tretinoin	1 in 1 CARTON	CREAM	1	16
0472-0117-20	Tretinoin	20 g in 1 TUBE	CREAM	20	16
0472-0117-45	Tretinoin	1 in 1 CARTON	CREAM	1	16
0472-0117-45	Tretinoin	45 g in 1 TUBE	CREAM	45	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0472-0117-20	GM - Gram	0472-0117	fffa3905-688e-4091-bc1a-3795b207ca3f	1	2013-02-13
0472-0117-45	GM - Gram	0472-0117	0a078fb6-8e59-4f24-859d-9d054fd43ad3	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRETINOIN	ACTIVE INGREDIENT	5688UTC01R	TRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]	3
TRETINOIN	ACTIVE MOIETY	5688UTC01R	TRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]	3
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	TRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]	3
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	TRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]	3
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	TRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]	3
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	TRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]	3
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	TRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	TRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0472-0117	TRETINOIN CREAM [ACTAVIS PHARMA, INC.]	16	Current NDC, Legacy NDC, 4 package rows	20250403_b5e385a2-f6f9-41cb-8a33-eedba397043f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin	TRETINOIN	Actavis Pharma, Inc.	b5e385a2-f6f9-41cb-8a33-eedba397043f	2024-12-11	Adverse reactions	Exact identifier application applno (NDA): 020404 application number: NDA020404 ndc (package): 0472-0117-45 ndc (product): 0472-0117 ndc11 (package): 00472011745
Tretinoin	TRETINOIN	A-S Medication Solutions	c7860dcd-91b0-44e0-98d6-a843b16457e1	2023-10-25	Adverse reactions	Exact identifier application applno (NDA): 020404 application number: NDA020404

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
106302	tretinoin 0.025 % Topical Cream	PSN	c7860dcd-91b0-44e0-98d6-a843b16457e1	19
106302	tretinoin 0.25 MG/ML Topical Cream	SCD	c7860dcd-91b0-44e0-98d6-a843b16457e1	19
106302	tretinoin 0.025 % Topical Cream	SY	c7860dcd-91b0-44e0-98d6-a843b16457e1	19
106302	tretinoin 0.025 % Topical Cream	PSN	b5e385a2-f6f9-41cb-8a33-eedba397043f	16
106302	tretinoin 0.25 MG/ML Topical Cream	SCD	b5e385a2-f6f9-41cb-8a33-eedba397043f	16
106302	tretinoin 0.025 % Topical Cream	SY	b5e385a2-f6f9-41cb-8a33-eedba397043f	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0472-0117-45	00472011745	1 TUBE in 1 CARTON (0472-0117-45) / 45 g in 1 TUBE	1 tube	1998-04-20	2027-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRETINOIN CREAM USP, 0.025%	Actavis Pharma, Inc.	2024-12-11	HUMAN PRESCRIPTION DRUG LABEL	16
TRETINOIN CREAM USP, 0.025%	A-S Medication Solutions	2023-10-25	HUMAN PRESCRIPTION DRUG LABEL	19
TRETINOIN CREAM USP, 0.025%	RPK Pharmaceuticals, Inc.	2020-12-23	HUMAN PRESCRIPTION DRUG LABEL	1
Tretinopak	PureTek Corporation	2019-04-03	HUMAN PRESCRIPTION DRUG LABEL	2