Sodium Chloride

Product NDC: 0338-0051
11-digit product format: 003380051
Labeler code: 0338
Product ID: 0338-0051_6759cb16-bc55-4635-94c0-5450f64adb76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Chloride
Dosage form: IRRIGANT
Route: IRRIGATION
Labeler: Baxter Healthcare Corporation
Application: NDA019319
Marketing category: NDA
Marketing start: 1985-05-17
Substance: SODIUM CHLORIDE
Active strength: 9 g/1000mL
Pharmacologic classes: Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
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
N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		RLD, RS	1985-05-17

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	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM CHLORIDE	9 g/1000mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
451W47IQ8X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
486515	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
7c72520e-de3c-493d-8aea-11933376d968	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0338-0051-44	2021-08-03	C162847	48780-1	c7ccaba7-0edf-fd44-e053-dadaa90aa01b	0.9% Sodium Chloride Irrigation, USP Baxter Sterile Container System
0338-0051-44	2021-07-23	C162847	48780-1	c7ccaba7-0edf-fd44-e053-dadaa90aa01b	0.9% Sodium Chloride Irrigation, USP Baxter Sterile Container System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-0051-44	Sodium Chloride	1000 mL in 1 BAG	IRRIGANT	1000		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-0051-44	ML - Milliliter	0338-0051	caded4d5-d511-441e-9067-161873cf599e	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	SODIUM CHLORIDE IRRIGANT [BAXTER HEALTHCARE CORPORATION]	3
CHLORIDE ION	ACTIVE MOIETY	Q32ZN48698	SODIUM CHLORIDE IRRIGANT [BAXTER HEALTHCARE CORPORATION]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	SODIUM CHLORIDE IRRIGANT [BAXTER HEALTHCARE CORPORATION]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-0051	SODIUM CHLORIDE IRRIGANT [BAXTER HEALTHCARE CORPORATION]	10	Current NDC, Legacy NDC, 1 package rows	20250516_7c72520e-de3c-493d-8aea-11933376d968.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
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	7c72520e-de3c-493d-8aea-11933376d968	2018-04-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019319 application number: NDA019319 ndc (product): 0338-0051

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
451W47IQ8X	SODIUM CHLORIDE	7647-14-5	SODIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
486515	sodium chloride 0.9 % Irrigation Solution	PSN	7c72520e-de3c-493d-8aea-11933376d968	11
486515	sodium chloride 0.154 MEQ/ML Irrigation Solution	SCD	7c72520e-de3c-493d-8aea-11933376d968	11
486515	NaCl 0.154 MEQ/ML Irrigation Solution	SY	7c72520e-de3c-493d-8aea-11933376d968	11
486515	sodium chloride 0.9 % Irrigation Solution	SY	7c72520e-de3c-493d-8aea-11933376d968	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-0051-44	00338005144	1000 mL in 1 BAG (0338-0051-44)	1000 ml	1985-05-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
0.9% Sodium Chloride Irrigation, USP Baxter Sterile Container System	Baxter Healthcare Corporation	2018-04-02	HUMAN PRESCRIPTION DRUG LABEL	11