Tretinoin

Product NDC: 68682-513
11-digit product format: 686820513
Labeler code: 68682
Product ID: 68682-513_c4ef7e4d-9c2e-4022-b7ab-b55962c1a58a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tretinoin
Dosage form: GEL
Route: TOPICAL
Labeler: Oceanside Pharmaceuticals
Application: NDA020475
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-03-14
Substance: TRETINOIN
Active strength: 1 mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020475-001	RETIN-A MICRO	TRETINOIN	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07
N020475-002	RETIN-A MICRO	TRETINOIN	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10
N020475-003	RETIN-A-MICRO	TRETINOIN	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28
N020475-004	RETIN-A-MICRO	TRETINOIN	0.06%	GEL / TOPICAL	AB	RLD, RS	2017-10-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020475-003	AB
N020475-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020475-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020475-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020475-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020475-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020475-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020475-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020475-003	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	N020475-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020475-002	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020475-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020475-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020475-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020475-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020475-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020475-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020475-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020475-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020475-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020475-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020475-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020475-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020475-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020475-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020475-003	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020475-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020475-004	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRETINOIN	1 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313453	Internal RxNorm lookup
359050	Internal RxNorm lookup
1488045	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
d3c528d2-429d-4f37-9ebf-eee8b9fd3050	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
68682-513-82	Tretinoin	1 in 1 CARTON	GEL	1	13
68682-513-82	Tretinoin	20 g in 1 TUBE	GEL	20	13
68682-513-84	Tretinoin	1 in 1 CARTON	GEL	1	13
68682-513-84	Tretinoin	45 g in 1 TUBE	GEL	45	13
68682-513-85	Tretinoin	1 in 1 CARTON	GEL	1	13
68682-513-85	Tretinoin	50 g in 1 BOTTLE, PUMP	GEL	50	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-513-82	GM - Gram	68682-513	45d170c4-dae8-48a4-ac00-1d26bc46420f	1	2013-04-01
68682-513-84	GM - Gram	68682-513	337799c1-9c19-48a3-9754-18e6c1aa6771	1	2013-04-01
68682-513-85	GM - Gram	68682-513	4fa29b6b-179a-451d-92c7-a130375b62b9	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tretinoin	ACTIVE INGREDIENT	5688UTC01R	TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]	1
Tretinoin	ACTIVE MOIETY	5688UTC01R	TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]	1
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]	1
Butylated Hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]	1
Carbomer Homopolymer Type B	INACTIVE INGREDIENT	HHT01ZNK31	TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]	1
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)	INACTIVE INGREDIENT	HHT01ZNK31	TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]	1
Sorbic Acid	INACTIVE INGREDIENT	X045WJ989B	TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-513	TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]	10	Current NDC, Legacy NDC, 6 package rows	20240410_d3c528d2-429d-4f37-9ebf-eee8b9fd3050.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	Oceanside Pharmaceuticals	d3c528d2-429d-4f37-9ebf-eee8b9fd3050	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020475 application number: NDA020475 ndc (product): 68682-513
Retin-A MICRO	TRETINOIN	Bausch Health US LLC	08ab7e0c-1437-455f-815c-98904d96a289	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020475 application number: NDA020475

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
359050	tretinoin 0.04 % Topical Gel	PSN	d3c528d2-429d-4f37-9ebf-eee8b9fd3050	13
1488045	tretinoin 0.08 % Topical Gel	PSN	d3c528d2-429d-4f37-9ebf-eee8b9fd3050	13
313453	tretinoin 0.1 % Topical Gel	PSN	d3c528d2-429d-4f37-9ebf-eee8b9fd3050	13
359050	tretinoin 0.0004 MG/MG Topical Gel	SCD	d3c528d2-429d-4f37-9ebf-eee8b9fd3050	13
1488045	tretinoin 0.0008 MG/MG Topical Gel	SCD	d3c528d2-429d-4f37-9ebf-eee8b9fd3050	13
313453	tretinoin 0.001 MG/MG Topical Gel	SCD	d3c528d2-429d-4f37-9ebf-eee8b9fd3050	13
359050	tretinoin 0.04 % Topical Gel	SY	d3c528d2-429d-4f37-9ebf-eee8b9fd3050	13
1488045	tretinoin 0.08 % Topical Gel	SY	d3c528d2-429d-4f37-9ebf-eee8b9fd3050	13
313453	tretinoin 0.1 % Topical Gel	SY	d3c528d2-429d-4f37-9ebf-eee8b9fd3050	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-513-82	68682051382	1 TUBE in 1 CARTON (68682-513-82) / 20 g in 1 TUBE	1 tube	2013-03-14	0000-00-00	No	No	Current
68682-513-84	68682051384	1 TUBE in 1 CARTON (68682-513-84) / 45 g in 1 TUBE	1 tube	2013-03-14	0000-00-00	No	No	Current
68682-513-85	68682051385	1 BOTTLE, PUMP in 1 CARTON (68682-513-85) / 50 g in 1 BOTTLE, PUMP		2013-03-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tretinoin	Oceanside Pharmaceuticals \| Bausch Health Companies Inc.	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	13