TIS-U-SOL

Manufacturer
Baxter Healthcare Corporation
Effective date
2014-02-21
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 22:15:26

Label at a glance#

ProductTIS-U-SOL
Active ingredientSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE HEPTAHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, MONOBASIC POTASSIUM PHOSPHATE
Label structure5 sections

Indications and uses

Isotonic solution for irrigation only. Not for injection.

Dosage and administration

As directed by a physician. Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Tis-U-Sol® Solution

(Pentalyte Irrigation)

Each 100 mL contains: 800 mg Sodium Chloride, USP, 40 mg Potassium Chloride, USP, 20 mg Magnesium Sulfate, Heptahydrate, USP, 8.75 mg Dibasic Sodium Phosphate, Heptahydrate, USP, 6.25 mg Monobasic Potassium Phosphate, NF. No antimicrobial agent has been added. pH 6.5 (4.0 to 7.0). Osmolarity 288 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Isotonic solution for irrigation only. Not for injection.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

As directed by a physician.

Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

HOW SUPPLIED

HOW SUPPLIED SECTION

Recommended storage: Room temperature (25°C). Avoid excessive heat.

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Representative Container Label for Tis-U-Sol, NDC 0338-0190-04
Representative Container Label for Tis-U-Sol, NDC 0338-0190-04

2F7144
NDC 0338-0190-04

1000 mL
DIN 00800007

Baxter Logo
Not for Injection

Tis-U-Sol® Solution
(Pentalyte Irrigation)

Each 100 mL contains: 800 mg Sodium Chloride, USP,
40 mg Potassium Chloride, USP, 20 mg Magnesium
Sulfate, Heptahydrate, USP, 8.75 mg Dibasic Sodium
Phosphate, Heptahydrate, USP, 6.25 mg Monobasic
Potassium Phosphate, NF. No antimicrobial agent has
been added. pH 6.5 (4.0 to 7.0). Osmolarity 288
mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.
Isotonic solution for irrigation only. Dosage and
Administration: As directed by a physician. Cautions:
Warm in oven to not more than 50°C for a maximum
of 60 days. Discard after 60 days of warming. Do not
use unless solution is clear and seal is intact. Discard
unused portion. Rx only. Recommended storage: Room
temperature (25°C). Avoid excessive heat.

PL 325 plastic

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Made in USA

Distributed in Canada by
Baxter Corporation
Mississauga, ON
L5N OC2

07-09-68-118

Bar Code Position Only*
303380190041

LOT
EXP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
801442magnesium sulfate 0.2 MG/mL / monobasic K+ phosphate 0.063 MG/mL / K+ chloride 0.005 MEQ/mL / NaCl 0.14 MEQ/mL / sodium phosphate dihydrate 0.088 MG/mL Irrigation SolutionPSN10
801445Tis-U-Sol 20 MG / 6.25 MG / 40 MG / 800 MG / 8.75 MG in 100 mL Irrigation SolutionPSN10
801445magnesium sulfate 0.2 MG/ML / monobasic potassium phosphate 0.063 MG/ML / potassium chloride 0.005 MEQ/ML / sodium chloride 0.14 MEQ/ML / sodium phosphate dihydrate 0.088 MG/ML Irrigation Solution [Tis-U-Sol]SBD10
801442magnesium sulfate 0.2 MG/ML / monobasic potassium phosphate 0.063 MG/ML / potassium chloride 0.005 MEQ/ML / sodium chloride 0.14 MEQ/ML / sodium phosphate dihydrate 0.088 MG/ML Irrigation SolutionSCD10
801442Magnesium Sulfate 0.2 MG/ML / Monobasic K+ phosphate 0.063 MG/ML / K+ Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation SolutionSY10
801445Magnesium Sulfate 0.2 MG/ML / Monobasic K+ phosphate 0.063 MG/ML / K+ Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation Solution [Tis-U-Sol]SY10
801442Magnesium Sulfate 0.2 MG/ML / Monobasic Pot phosphate 0.063 MG/ML / Pot Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation SolutionSY10
801445Magnesium Sulfate 0.2 MG/ML / Monobasic Pot phosphate 0.063 MG/ML / Pot Chloride 0.005 MEQ/ML / NaCl 0.14 MEQ/ML / SODIUM PHOSPHATE DIHYDRATE 0.088 MG/ML Irrigation Solution [Tis-U-Sol]SY10
801445Tis-U-Sol (magnesium sulfate 20 MG / monobasic potassium phosphate 6.25 MG / potassium chloride 40 MG / sodium chloride 800 MG / sodium phosphate dihydrate 8.75 MG per 100 ML) Irrigation SolutionSY10
801445Tis-U-Sol Irrigation SolutionSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813
POTASSIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0338-0190-042023-09-01C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042023-09-01C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042023-09-01C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042023-07-28C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042023-07-28C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042023-07-28C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042020-10-30C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042020-10-30C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042020-10-30C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042020-09-27C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042020-09-27C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042020-09-27C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042020-09-25C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042020-09-25C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042020-09-25C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042020-07-22C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042020-07-22C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f
0338-0190-042020-07-22C16284748780-1ab0e2407-2c6d-f274-e053-dbdaa90a64719da4121f-d62d-4da4-8dfb-0494da16015f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-0190-04TIS-U-SOL1000 mL in 1 BOTTLE, PLASTICIRRIGANT100010
0338-0190-04TIS-U-SOL12 in 1 CARTONIRRIGANT1210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0190-04ML - Milliliter0338-0190b291b298-7eda-4731-bdd5-ec9fa25bef2612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MAGNESIUM SULFATE HEPTAHYDRATEACTIVE INGREDIENTSK47B8698T2
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I102
POTASSIUM PHOSPHATE, MONOBASICACTIVE INGREDIENT4J9FJ0HL512
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X2
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEACTIVE INGREDIENT70WT22SF4B2
CHLORIDE IONACTIVE MOIETYQ32ZN486982
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8382
PHOSPHATE IONACTIVE MOIETYNK08V8K8HR2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0338-01900338-0190-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92014-02-21monthly-update2026-06-03 17:41:55
82014-02-21full-release2026-05-31 21:13:07

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018508-001TIS-U-SOLMAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N018508-001AT

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-1984e616aacf4f…
2026-08-18 06:07:402026-07N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-193f01610625f2…
2019-09-15 20:21 UTC2019-09N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018508-001TIS-U-SOL20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100MLSOLUTION / IRRIGATIONAT1982-02-19f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N018508-001AT184e616aacf4f…
2026-08-18 06:07:402026-07N018508-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018508-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018508-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018508-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018508-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018508-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018508-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018508-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018508-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018508-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018508-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018508-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018508-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018508-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018508-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018508-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018508-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018508-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018508-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018508-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018508-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018508-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N018508-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018508-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018508-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018508-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N018508-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018508-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018508-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018508-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018508-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018508-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018508-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018508-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018508-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018508-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018508-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018508-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018508-001AT1f41ea6bd6efb…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
ndc (package): 0338-0190-04
ndc (product): 0338-0190
ndc11 (package): 00338019004
spl id: 313abeef-1c8f-4fb4-9e6d-3b3737102c7e
spl set id: 9da4121f-d62d-4da4-8dfb-0494da16015f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.