Sterile Water

Product NDC: 0338-0004
11-digit product format: 003380004
Labeler code: 0338
Product ID: 0338-0004_97390588-b679-4caa-b7f3-3d2e11074d0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Water
Dosage form: IRRIGANT
Route: IRRIGATION
Labeler: Baxter Healthcare Corporation
Application: NDA017428
Marketing category: NDA
Marketing start: 1974-12-31
Substance: WATER
Active strength: 100 mL/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0338-0004	0338-0004-05	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N017428-001	STERILE WATER	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
N017428-001	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	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017428-001	STERILE WATER	100%	LIQUID / IRRIGATION	AT	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017428-001	STERILE WATER	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	N017428-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017428-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017428-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017428-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017428-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017428-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017428-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017428-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017428-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017428-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017428-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017428-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017428-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017428-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017428-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017428-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017428-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017428-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017428-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017428-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017428-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017428-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017428-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017428-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017428-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017428-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017428-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017428-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017428-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017428-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017428-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017428-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017428-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017428-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017428-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017428-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017428-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017428-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017428-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017428-001	AT	1	`e64feba35796…`

Additional Listing Data#

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

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
ef3e79c5-3f58-4b36-a296-64b7d9a651c1	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0338-0004-02	Sterile Water	24 in 1 CARTON	IRRIGANT	24	16
0338-0004-02	Sterile Water	250 mL in 1 BOTTLE, PLASTIC	IRRIGANT	250	16
0338-0004-03	Sterile Water	18 in 1 CARTON	IRRIGANT	18	16
0338-0004-03	Sterile Water	500 mL in 1 BOTTLE, PLASTIC	IRRIGANT	500	16
0338-0004-04	Sterile Water	1000 mL in 1 BOTTLE, PLASTIC	IRRIGANT	1000	16
0338-0004-04	Sterile Water	12 in 1 CARTON	IRRIGANT	12	16
0338-0004-05	Sterile Water	1500 mL in 1 BOTTLE, PLASTIC	IRRIGANT	1500	16
0338-0004-05	Sterile Water	9 in 1 CARTON	IRRIGANT	9	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-0004-02	ML - Milliliter	0338-0004	97a1a26a-8bbb-4cad-8455-fae5ff1747e3	1	2012-07-24
0338-0004-03	ML - Milliliter	0338-0004	b8f88bb5-7ea5-4093-8e7b-89e5f3af2f7b	1	2013-02-13
0338-0004-04	ML - Milliliter	0338-0004	24fbca35-41e2-431e-97e2-19f0ca2b522c	1	2012-07-24
0338-0004-05	ML - Milliliter	0338-0004	1ed29dd4-04b1-43e5-874f-62b19ba6b642	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WATER	ACTIVE INGREDIENT	059QF0KO0R	STERILE WATER (WATER) IRRIGANT [BAXTER HEALTHCARE CORPORATION]	4
WATER	ACTIVE MOIETY	059QF0KO0R	STERILE WATER (WATER) IRRIGANT [BAXTER HEALTHCARE CORPORATION]	4
WATER	ACTIVE INGREDIENT	059QF0KO0R	STERILE WATER IRRIGANT [BAXTER HEALTHCARE CORPORATION]	2
WATER	ACTIVE MOIETY	059QF0KO0R	STERILE WATER IRRIGANT [BAXTER HEALTHCARE CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-0004	STERILE WATER (WATER) IRRIGANT [BAXTER HEALTHCARE CORPORATION]	15	Current NDC, Legacy NDC, 8 package rows	20250522_ef3e79c5-3f58-4b36-a296-64b7d9a651c1.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
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017428 application number: NDA017428 ndc (product): 0338-0004

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	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	16
150985	water 1000 MG/ML Irrigation Solution	SCD	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	16
150985	water 100 % Irrigation Solution	SY	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-0004-02	00338000402	24 BOTTLE, PLASTIC in 1 CARTON (0338-0004-02) / 250 mL in 1 BOTTLE, PLASTIC	1974-12-31	0000-00-00	No	No	Current
0338-0004-03	00338000403	18 BOTTLE, PLASTIC in 1 CARTON (0338-0004-03) / 500 mL in 1 BOTTLE, PLASTIC	1974-12-31	0000-00-00	No	No	Current
0338-0004-04	00338000404	12 BOTTLE, PLASTIC in 1 CARTON (0338-0004-04) / 1000 mL in 1 BOTTLE, PLASTIC	1974-12-31	0000-00-00	No	No	Current
0338-0004-05	00338000405	9 BOTTLE, PLASTIC in 1 CARTON (0338-0004-05) > 1500 mL in 1 BOTTLE, PLASTIC	1974-12-31	2022-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sterile Water - Baxter Healthcare Corporation	Baxter Healthcare Corporation	2017-10-17	HUMAN PRESCRIPTION DRUG LABEL	16
STERILE WATER - Baxter Healthcare Corporation	Baxter Healthcare Corporation	2014-02-21	HUMAN PRESCRIPTION DRUG LABEL	2