Renova

Product NDC: 0187-5150
11-digit product format: 001875150
Labeler code: 0187
Product ID: 0187-5150_440beed5-a673-423d-84e8-4f3432c37ee8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tretinoin
Dosage form: CREAM
Route: TOPICAL
Labeler: Bausch Health US LLC
Application: NDA021108
Marketing category: NDA
Marketing start: 2000-08-31
Substance: TRETINOIN
Active strength: .2 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021108-001	RENOVA	TRETINOIN	0.02%	CREAM / TOPICAL		RLD, RS	2000-08-31

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021108-001	RENOVA	0.02%	CREAM / TOPICAL	RLD, RS	2000-08-31	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021108-001	6531141	2020-03-07	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021108-001	6531141	2020-03-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021108-001	6531141	2020-03-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021108-001	6531141	2020-03-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021108-001	6531141	2020-03-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021108-001	6531141	2020-03-07	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRETINOIN	.2 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
252265	Internal RxNorm lookup
846955	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
9f0a0e8d-1051-48a4-80c5-1bd260dd9c36	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
0187-5150-02	Renova	2 g in 1 TUBE	CREAM	2	14
0187-5150-02	Renova	1 in 1 CARTON	CREAM	1	14
0187-5150-20	Renova	1 in 1 CARTON	CREAM	1	14
0187-5150-20	Renova	20 g in 1 TUBE	CREAM	20	14
0187-5150-40	Renova	1 in 1 CARTON	CREAM	1	14
0187-5150-40	Renova	40 g in 1 TUBE	CREAM	40	14
0187-5150-44	Renova	44 g in 1 BOTTLE, PUMP	CREAM	44	14
0187-5150-44	Renova	1 in 1 CARTON	CREAM	1	14
0187-5150-60	Renova	60 g in 1 TUBE	CREAM	60	14
0187-5150-60	Renova	1 in 1 CARTON	CREAM	1	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-5150-20	GM - Gram	0187-5150	5afa4192-7fe5-4f80-afa9-13e8a501e0a4	1	2019-09-05
0187-5150-44	GM - Gram	0187-5150	1f9c3c24-01a0-4926-a9fb-08c6bc7abadc	1	2013-11-04
0187-5150-60	GM - Gram	0187-5150	ef354477-f02b-4adb-84fa-0a7757d99642	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tretinoin	ACTIVE INGREDIENT	5688UTC01R	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Tretinoin	ACTIVE MOIETY	5688UTC01R	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Butylated Hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Medium-Chain Triglycerides	INACTIVE INGREDIENT	C9H2L21V7U	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Steareth-2	INACTIVE INGREDIENT	V56DFE46J5	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Steareth-20	INACTIVE INGREDIENT	L0Q8IK9E08	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Water	INACTIVE INGREDIENT	059QF0KO0R	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-5150	RENOVA (TRETINOIN) CREAM [BAUSCH HEALTH US LLC]	12	Current NDC, Legacy NDC, 10 package rows	20200924_9f0a0e8d-1051-48a4-80c5-1bd260dd9c36.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Renova	TRETINOIN	Bausch Health US LLC	9f0a0e8d-1051-48a4-80c5-1bd260dd9c36	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021108 application number: NDA021108 ndc (product): 0187-5150

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
846955	RENOVA 0.02 % Topical Cream	PSN	9f0a0e8d-1051-48a4-80c5-1bd260dd9c36	14
252265	tretinoin 0.02 % Topical Cream	PSN	9f0a0e8d-1051-48a4-80c5-1bd260dd9c36	14
846955	tretinoin 0.2 MG/ML Topical Cream [Renova]	SBD	9f0a0e8d-1051-48a4-80c5-1bd260dd9c36	14
252265	tretinoin 0.2 MG/ML Topical Cream	SCD	9f0a0e8d-1051-48a4-80c5-1bd260dd9c36	14
846955	Renova 0.02 % Topical Cream	SY	9f0a0e8d-1051-48a4-80c5-1bd260dd9c36	14
846955	Renova 0.2 MG/ML Topical Cream	SY	9f0a0e8d-1051-48a4-80c5-1bd260dd9c36	14
252265	tretinoin 0.02 % Topical Cream	SY	9f0a0e8d-1051-48a4-80c5-1bd260dd9c36	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-5150-02	00187515002	1 TUBE in 1 CARTON (0187-5150-02) / 2 g in 1 TUBE	1 tube	2000-08-31	0000-00-00	No	No	Current
0187-5150-20	00187515020	1 TUBE in 1 CARTON (0187-5150-20) / 20 g in 1 TUBE	1 tube	2000-08-31	0000-00-00	No	No	Current
0187-5150-40	00187515040	1 TUBE in 1 CARTON (0187-5150-40) / 40 g in 1 TUBE	1 tube	2000-08-31	0000-00-00	No	No	Current
0187-5150-44	00187515044	1 BOTTLE, PUMP in 1 CARTON (0187-5150-44) / 44 g in 1 BOTTLE, PUMP		2000-08-31	0000-00-00	No	No	Current
0187-5150-60	00187515060	1 TUBE in 1 CARTON (0187-5150-60) / 60 g in 1 TUBE	1 tube	2000-08-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RENOVA ® (tretinoin) Cream 0.02%	Bausch Health US LLC \| Bausch Health Companies Inc.	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	14