RIMSO-50

Product NDC: 67457-177
11-digit product format: 674570177
Labeler code: 67457
Product ID: 67457-177_ed5bd01d-2175-457e-ae65-7197f40d7342
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dimethyl Sulfoxide
Dosage form: IRRIGANT
Route: INTRAVESICAL
Labeler: Mylan Institutional LLC
Application: NDA017788
Marketing category: NDA
Marketing start: 1978-04-04
Substance: DIMETHYL SULFOXIDE
Active strength: .54 g/mL
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 43.

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
N017788-001	RIMSO-50	DIMETHYL SULFOXIDE	50%	SOLUTION / INTRAVESICAL	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017788-001	AT

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL	AT	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL	AT	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017788-001	RIMSO-50	50%	SOLUTION / INTRAVESICAL		RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N017788-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017788-001	AT	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017788-001	AT	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: RIMSO-50
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHYL SULFOXIDE	.54 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YOW8V9698H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
208361	Internal RxNorm lookup
562359	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
58b25d79-78f2-4953-b0c6-61658dc4ef0d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67457-177-50	RIMSO-50	1 in 1 CARTON	IRRIGANT	1		9
67457-177-50	RIMSO-50	50 mL in 1 VIAL, GLASS	IRRIGANT	50		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-177-50	ML - Milliliter	67457-177	221f70bc-8cf9-46ff-93e0-25e75212ce4a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dimethyl Sulfoxide	ACTIVE INGREDIENT	YOW8V9698H	RIMSO-50 (DIMETHYL SULFOXIDE) IRRIGANT [MYLAN INSTITUTIONAL LLC]	4
Dimethyl Sulfoxide	ACTIVE MOIETY	YOW8V9698H	RIMSO-50 (DIMETHYL SULFOXIDE) IRRIGANT [MYLAN INSTITUTIONAL LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	RIMSO-50 (DIMETHYL SULFOXIDE) IRRIGANT [MYLAN INSTITUTIONAL LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-177	RIMSO-50 (DIMETHYL SULFOXIDE) IRRIGANT [MYLAN INSTITUTIONAL LLC]	9	Current NDC, Legacy NDC, 2 package rows	20210501_58b25d79-78f2-4953-b0c6-61658dc4ef0d.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
RIMSO-50	DIMETHYL SULFOXIDE	Mylan Institutional LLC	58b25d79-78f2-4953-b0c6-61658dc4ef0d	2021-03-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017788 application number: NDA017788 ndc (product): 67457-177

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YOW8V9698H	DIMETHYL SULFOXIDE	67-68-5	DIMETHYL SULFOXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
562359	dimethyl sulfoxide 50 % Irrigation Solution	PSN	58b25d79-78f2-4953-b0c6-61658dc4ef0d	9
208361	RIMSO-50 50 % Irrigation Solution	PSN	58b25d79-78f2-4953-b0c6-61658dc4ef0d	9
208361	dimethyl sulfoxide 500 MG/ML Irrigation Solution [Rimso-50]	SBD	58b25d79-78f2-4953-b0c6-61658dc4ef0d	9
562359	dimethyl sulfoxide 500 MG/ML Irrigation Solution	SCD	58b25d79-78f2-4953-b0c6-61658dc4ef0d	9
562359	dimethyl sulfoxide 50 % Intravesical Solution	SY	58b25d79-78f2-4953-b0c6-61658dc4ef0d	9
562359	dimethyl sulfoxide 50 % Irrigation Solution	SY	58b25d79-78f2-4953-b0c6-61658dc4ef0d	9
208361	Rimso-50 50 % Irrigation Solution	SY	58b25d79-78f2-4953-b0c6-61658dc4ef0d	9
208361	Rimso-50 500 MG/ML Irrigation Solution	SY	58b25d79-78f2-4953-b0c6-61658dc4ef0d	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-177-50	67457017750	1 VIAL, GLASS in 1 CARTON (67457-177-50) / 50 mL in 1 VIAL, GLASS	1978-04-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RIMSO-50 ® brand of dimethyl sulfoxide irrigation, USP	Mylan Institutional LLC	2021-03-17	HUMAN PRESCRIPTION DRUG LABEL	9