Indications and uses
3% and 5% Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.
Sodium Chloride - Baxter Healthcare Corporation
- Manufacturer
- Baxter Healthcare Corporation
- Effective date
- 2006-01-12
- Label type
- HUMAN PRESCRIPTION DRUG LABELING
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:06:52
Label at a glance#
ProductSodium Chloride
Label structure8 sections
Contacts and useful links#
Label contents#
Full prescribing information#
DESCRIPTION
3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents. Composition, ionic concentration, osmolarity, and pH are shown in Table 1.
| Table 1 | ||||||
| Size (mL) | Composition (g/L) | Ionic Concentration (mEq/L) | *Osmolarity (mOsmol/L) (calc) | pH | ||
| Sodium Chloride, USP (NaCl) | Sodium | Chloride | ||||
| 3% Sodium Chloride Injection, USP | 500 | 30 | 513 | 513 | 1027 | 5.0 (4.5 to 7.0) |
| 5% Sodium Chloride Injection, USP | 500 | 50 | 856 | 856 | 1711 | 5.0 (4.5 to 7.0) |
* Normal physiological osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage.
The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
CLINICAL PHARMACOLOGY
3% and 5% Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.
INDICATIONS AND USAGE
3% and 5% Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.
CONTRAINDICATIONS
None known
WARNINGS
3% and 5% Sodium Chloride Injection, USP is strongly hypertonic and may cause vein damage.
3% and 5% Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.
In patients with diminished renal function, administration of 3% and 5% Sodium Chloride Injection, USP may result in sodium retention.
GENERAL PRECAUTIONS
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.
Caution must be exercised in the administration of 3% and 5% Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.
Pregnancy
Teratogenic Effects
Pregnancy Category C
Animal reproduction studies have not been conducted with 3% and 5% Sodium Chloride Injection, USP. It is also not known whether 3% and 5% Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 3% and 5% Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed.
Pediatric Use
Safety and effectiveness of 3% and 5% Sodium Chloride Injection, USP in pediatric patients have not been established by adequate and well controlled trials, however, the use of sodium chloride solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.
Geriatric Use
Clinical studies of 3% and 5% Sodium Chloride Injection, USP, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Do not administer unless solution is clear and seal is intact.
ADVERSE REACTIONS
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
HOW SUPPLIED
3% and 5% Sodium Chloride Injection, USP in VIAFLEX plastic container is available as follows:
| Code | Size (mL) | NDC | Product Name |
| 2b1353 | 500 | 0338-0054-03 | 3% Sodium Chloride Injection, USP |
| 2B1373 | 500 | 0338-0056-03 | 5% Sodium Chloride Injection, USP |
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.
Directions for Use of VIAFLEX Plastic Container
Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
To Open
Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.
Preparation for Administration
- Suspend container from eyelet support.
- Remove plastic protector from outlet port at bottom of container.
- Attach administration set. Refer to complete directions accompanying set.
To Add Medication
Warning: Additives may be incompatible.
To add medication before solution administration
- Prepare medication site
- Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
- Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.
To add medication during solution administration
- Close clamp on the set.
- Prepare medication site.
- Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
- Remove container from IV pole and/or turn to an upright position.
- Evacuate both ports by squeezing them while container is in the upright position.
- Mix solution and medication thoroughly.
- Return container to in use position and continue administration.
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 730781 | sodium chloride 3 % per 500 ML Injection | PSN | 1 |
| 730782 | sodium chloride 5 % in 500 ML Injection | PSN | 1 |
| 730781 | 500 ML sodium chloride 30 MG/ML Injection | SCD | 1 |
| 730782 | 500 ML sodium chloride 50 MG/ML Injection | SCD | 1 |
| 730781 | 500 ML NaCl 30 MG/ML Injection | SY | 1 |
| 730782 | 500 ML NaCl 50 MG/ML Injection | SY | 1 |
| 730781 | sodium chloride 3 % per 500 ML Injection | SY | 1 |
| 730782 | sodium chloride 5 % per 500 ML Injection | SY | 1 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0338-0054-03 | Sodium Chloride | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | 1 | |
| 0338-0056-03 | Sodium Chloride | 500 mL in 1 BAG | INJECTION, SOLUTION | 500 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0338-0054 | SODIUM CHLORIDE (SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 1 | Current NDC, Legacy NDC, 1 package rows | 20070323_fb77dffc-b38d-461c-8926-bc57bef1f321.zip |
| 0338-0056 | SODIUM CHLORIDE (SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 1 | Current NDC, Legacy NDC, 1 package rows | 20070323_fb77dffc-b38d-461c-8926-bc57bef1f321.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-0054-03 | ML - Milliliter | 0338-0054 | 961ac15e-c02b-47b8-a3c9-71d7112caf47 | 1 | 2013-02-11 |
| 0338-0056-03 | ML - Milliliter | 0338-0056 | dde15aaf-d5ef-455e-9368-bf7402b0749f | 1 | 2013-02-11 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Sodium Chloride | ACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| Sodium Chloride | ACTIVE MOIETY | 451W47IQ8X | 1 | |
| Hydrochloric Acid | INACTIVE INGREDIENT | QTT17582CB | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Sodium Chloride
- Hydrochloric Acid
- Water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0338-0054 | 0338-0054-03 |
| 0338-0056 | 0338-0056-03 |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRAVENOUS | 1037 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRAVENOUS | 1037 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRAVENOUS | 1037 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRAVENOUS | 1037 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 |
| N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019022-001 | AP |
| N019022-002 | AP |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N019022-001 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1983-11-01 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019022-002 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | RLD | 1983-11-01 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019022-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N019022-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N019022-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019022-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019022-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019022-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019022-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019022-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019022-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019022-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019022-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019022-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019022-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019022-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019022-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019022-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019022-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019022-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019022-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019022-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019022-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019022-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019022-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019022-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019022-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019022-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019022-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019022-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019022-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019022-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019022-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N019022-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019022-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019022-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019022-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N019022-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019022-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N019022-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N019022-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019022-002 | AP | 1 | 74a2ff9319b5… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 181705c7-40e4-4d7d-b9ea-ada99380e7a9 | 2018-05-23 | Warnings, Adverse reactions | 0338-0056-03 0338-0054-03 0338-0056 0338-0054 00338005403 00338005603 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.