Sterile Water

Product NDC: 0264-7386
11-digit product format: 002647386
Labeler code: 0264
Product ID: 0264-7386_5a720898-0d85-4a14-9507-d8835857bdc6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sterile Water
Dosage form: IRRIGANT
Route: IRRIGATION
Labeler: B. Braun Medical Inc.
Application: NDA016734
Marketing category: NDA
Marketing start: 2013-09-13
Substance: WATER
Active strength: 100 mL/100mL
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
N016734-001	STERILE WATER IN PLASTIC CONTAINER	STERILE WATER FOR IRRIGATION	100%	LIQUID / IRRIGATION	AT	RLD, 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
N016734-001	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 · 42 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
2026-08-18 06:07:40	2026-07	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016734-001	STERILE WATER IN PLASTIC CONTAINER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N016734-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016734-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016734-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016734-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016734-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016734-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016734-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016734-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016734-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016734-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016734-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016734-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016734-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016734-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016734-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016734-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016734-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016734-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016734-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016734-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016734-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016734-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016734-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016734-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016734-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016734-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016734-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016734-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016734-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016734-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016734-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016734-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016734-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016734-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016734-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016734-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016734-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016734-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016734-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016734-001	AT	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sterile Water
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
WATER	100 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
059QF0KO0R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
150985	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
d99f9133-e4d0-4dee-b611-dbc3f918b547	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0264-7386-50	Sterile Water	4 in 1 CASE	IRRIGANT	4	8
0264-7386-50	Sterile Water	2000 mL in 1 CONTAINER	IRRIGANT	2000	8
0264-7386-60	Sterile Water	4 in 1 CASE	IRRIGANT	4	8
0264-7386-60	Sterile Water	3000 mL in 1 CONTAINER	IRRIGANT	3000	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0264-7386-50	ML - Milliliter	0264-7386	5399841a-48cc-41fe-80e2-108bb59eb7f6	1	2015-06-09
0264-7386-60	ML - Milliliter	0264-7386	f84ed975-4c13-4ad0-9024-4b807bf39154	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
WATER	ACTIVE INGREDIENT	059QF0KO0R	STERILE WATER IRRIGANT [B. BRAUN MEDICAL INC.]	5
WATER	ACTIVE MOIETY	059QF0KO0R	STERILE WATER IRRIGANT [B. BRAUN MEDICAL INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0264-7386	STERILE WATER IRRIGANT [B. BRAUN MEDICAL INC.]	8	Current NDC, Legacy NDC, 4 package rows	20210814_d99f9133-e4d0-4dee-b611-dbc3f918b547.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
Sterile Water	WATER	B. Braun Medical Inc.	f4284eb6-e553-46d4-90d8-efc80a90a480	2023-09-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016734 application number: NDA016734
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016734 application number: NDA016734 ndc (product): 0264-7386

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
059QF0KO0R	WATER	7732-18-5	WATER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
150985	water 100 % Irrigation Solution	PSN	d99f9133-e4d0-4dee-b611-dbc3f918b547	8
150985	water 1000 MG/ML Irrigation Solution	SCD	d99f9133-e4d0-4dee-b611-dbc3f918b547	8
150985	water 100 % Irrigation Solution	SY	d99f9133-e4d0-4dee-b611-dbc3f918b547	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0264-7386-50	00264738650	4 CONTAINER in 1 CASE (0264-7386-50) / 2000 mL in 1 CONTAINER	4 container	2013-09-13	0000-00-00	No	No	Current
0264-7386-60	00264738660	4 CONTAINER in 1 CASE (0264-7386-60) / 3000 mL in 1 CONTAINER	4 container	2013-09-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sterile Water for Irrigation USP	B. Braun Medical Inc.	2021-08-09	HUMAN PRESCRIPTION DRUG LABEL	8