Sorbitol-Mannitol

Product NDC: 0990-7981
11-digit product format: 009907981
Labeler code: 0990
Product ID: 0990-7981_dda87a72-d2a8-41f8-8d73-52931a149dc0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SORBITOL and MANNITOL
Dosage form: IRRIGANT
Route: URETHRAL
Labeler: ICU Medical Inc.
Application: NDA018316
Marketing category: NDA
Marketing start: 2019-10-01
Substance: MANNITOL; SORBITOL
Active strength: .54; 2.7 g/100mL; g/100mL
Pharmacologic classes: Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]
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 42.

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
N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	MANNITOL; SORBITOL	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION		RLD, RS, Approved before 1982

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018316-001	SORBITOL-MANNITOL IN PLASTIC CONTAINER	540MG/100ML;2.7GM/100ML	SOLUTION / IRRIGATION	RLD, RS, Approved before 1982	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SORBITOL	.54 g/100mL
MANNITOL	2.7 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
506T60A25R	Internal UNII lookup
3OWL53L36A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311446	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
5b44e248-4b7b-4777-954a-921c7b309944	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0990-7981-08	Sorbitol-Mannitol	4 in 1 CASE	IRRIGANT	4		7
0990-7981-08	Sorbitol-Mannitol	1 in 1 POUCH	IRRIGANT	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0990-7981-08	ML - Milliliter	0990-7981	c200ceaf-6398-4e8c-8207-e352a567685b	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0990-7981	SORBITOL-MANNITOL (SORBITOL AND MANNITOL) IRRIGANT [ICU MEDICAL INC.]	5	Current NDC, Legacy NDC, 2 package rows	20221203_5b44e248-4b7b-4777-954a-921c7b309944.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
Sorbitol-Mannitol	SORBITOL AND MANNITOL	ICU Medical Inc.	5b44e248-4b7b-4777-954a-921c7b309944	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018316 application number: NDA018316 ndc (product): 0990-7981

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3OWL53L36A	MANNITOL	69-65-8	MANNITOL
506T60A25R	SORBITOL	50-70-4	SORBITOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311446	mannitol 0.54 GM / sorbitol 2.7 GM in 100 mL Irrigation Solution	PSN	5b44e248-4b7b-4777-954a-921c7b309944	7
311446	mannitol 5.4 MG/ML / sorbitol 27 MG/ML Irrigation Solution	SCD	5b44e248-4b7b-4777-954a-921c7b309944	7
311446	mannitol 0.54 GM / sorbitol 2.7 GM per 100 ML Irrigation Solution	SY	5b44e248-4b7b-4777-954a-921c7b309944	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0990-7981-08	00990798108	4 POUCH in 1 CASE (0990-7981-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG	4 pouch	2019-10-01	0000-00-00	No	No	Current