BSS™ Sterile Irrigating Solution (balanced salt solution)

Manufacturer
Alcon Laboratories, Inc. | Alcon Research LLC | S.A. Alcon-Couvreur N.V.
Effective date
2024-01-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-05-31 20:58:45

Label at a glance#

ProductBSS
Active ingredientSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, SODIUM CITRATE
Label structure9 sections

Indications and uses

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

Dosage and administration

The adapter plug is designed to accept an irrigating needle. Tissues may be irrigated by attaching the needle to the DROP-TAINER ® bottle as explained below. External irrigation may be done without the irrigating needle. Method of using Adapter Plug for LUER-LOK ® Hub Ophthalmic Irrigating Needle: 1. Aseptically remove DROP-TAINER bottle from blister by peeling paper backing. 2. Snap on surgeon's sterile irrigatio...

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

BSS™ Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl2•2H2O) 0.048%, magnesium chloride hexahydrate (MgCl2•6H2O) 0.03%, sodium acetate trihydrate (C2H3NaO2•3H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O7•2H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

BSS Sterile Irrigating Solution is an isotonic solution for use in irrigating tissues of the eyes.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

WARNINGS

WARNINGS SECTION

• NOT FOR INJECTION OR INTRAVENOUS INFUSION.

• Do not use unless product is clear, seal is intact, and container is undamaged.

• Do not use if product is discolored or contains a precipitate.

• SINGLE patient use only. The contents of this bottle should not be used in more than one patient.

• This solution contains no preservative, unused contents should be discarded.

PRECAUTIONS

PRECAUTIONS SECTION

Open under aseptic conditions only.

Prior to use, check the following: tip should be firmly in place, irrigating needle should be properly seated; squeeze out several drops before inserting into anterior chamber. The needle should be removed from the anterior chamber prior to releasing pressure to prevent suction.

Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed.

There have been reports of corneal clouding or edema following ocular surgery in which BSS Sterile Irrigating Solution was used as an irrigating solution.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy. Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

The adapter plug is designed to accept an irrigating needle. Tissues may be irrigated by attaching the needle to the DROP-TAINER® bottle as explained below. External irrigation may be done without the irrigating needle.

Method of using Adapter Plug for LUER-LOK® Hub Ophthalmic Irrigating Needle:

1. Aseptically remove DROP-TAINER bottle from blister by peeling paper backing.

2. Snap on surgeon's sterile irrigation needle. Push until firmly in place and twist slightly.

3. Test assembly for proper function before use.

NOTE: LUER-LOK is a registered trademark of Becton, Dickinson and Company.

HOW SUPPLIED

HOW SUPPLIED SECTION

In 15 mL and 30 mL sterile DROP-TAINER bottles (consisting of a polypropylene bottle and LEUR-LOK™ adapter plug with a white polypropylene closure) in a blister package.

15 mL in a 15 mL bottle:
NDC0065-0795-15

30 mL in a 30 mL bottle:
NDC0065-0795-30

STORAGE:Store at 36° - 77°F (2° - 25°C).

Revised: May 2021

Alcon

Distributed by:
Alcon Laboratories , Inc.
6201 South Freeway
Fort Worth, Texas 76134 USA

© 2021 Alcon Inc.
W300048945-0521

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0065-0795-15

BSS™
Sterile Irrigating Solution
(balanced salt solution)

ALCON

CONTENTS: 3 doz. 15mL Single Dose Bottles

STORAGE: Store at 36° - 77°F (2° - 25°C).

Rx Only

Alcon

Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA

300048944-0521

carton
carton

NDC 0065-0795-15

BSS®
Sterile Irrigating Solution
(balanced salt solution)

ALCON®
a Novartis company

CONTENTS: 3 doz. 15mL Single Dose Bottles

STORAGE: Store at 36° - 77°F (2° - 25°C).

Rx Only

Alcon®

Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA
© 2002, 2013, 2015 Novartis

9012635-1115

carton
carton

NDC 0065-0795-15

BSS®
Sterile Irrigating Solution
(balanced salt solution)

STERILE UNLESS PACKAGE OPEN OR BROKEN

15 mL DROP-TAINER® Bottle, SINGLE DOSE UNIT With Adapter for LUER-LOK® Hub Irrigating Needle

A sterile balanced salt solution for
extraocular and intraocular use during
procedures with an expected maximum
duration of less than 60 minutes. Read
enclosed insert.

WARNINGS:
• NOT FOR INJECTION OR INTRAVENOUSINFUSION.
• Do not use unless product is clear, seal is intact and container is undamaged.
• Do not use if blister or paper backing is damaged or broken.
• Do not use if product is discolored or contains a precipitate.
• SINGLE patient use only. The contents of this bottle should not be used in more than one patient.
• This solution contains no preservative, unused contents should be discarded.

PRECAUTIONS: Open under aseptic
conditions only.

Rx Only

Each mL contains: sodium chloride
0.64%, potassium chloride 0.075%, calcium chloride
dihydrate 0.048%, magnesium chloride hexahydrate 0.03%,
sodium acetate trihydrate 0.39%, sodium citrate dihydrate
0.17%, sodium hydroxide and/or hydrochloric acid (to adjust
pH), and water for injection.

STORAGE: Store at 36° - 77°F (2° - 25°C).

NOTE: LUER-LOK is a registered trademark of
Becton, Dickinson & Co.

Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA

Alcon

9017036-0119

Bottle Lable
Bottle Lable

NDC 0065-0795-15

BSS®
Sterile Irrigating Solution
(balanced salt solution)

STERILE UNLESS PACKAGE OPEN OR BROKEN

15 mL DROP-TAINER® Bottle, SINGLE DOSE UNIT With Adapter for LUER-LOK® Hub Irrigating Needle

A sterile balanced salt solution for extraocular and intraocular use during procedures with an expected maximum duration of less than 60 minutes. Read enclosed insert.

WARNINGS:
• NOT FOR INJECTION OR INTRAVENOUS INFUSION.
• Do not use unless product is clear, seal is intact and container is undamaged.
• Do not use if blister or paper backing is damaged or broken.
• Do not use if product is discolored or contains a precipitate.
• SINGLE patient use only. The contents of this bottle should not be used in more than one patient.
• This solution contains no preservative, unused contents should be discarded.

PRECAUTIONS: Open under aseptic conditions only.

Rx Only

Each mL contains: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dihydrate 0.048%, magnesium chloride hexahydrate 0.03%, sodium acetate trihydrate 0.39%, sodium citrate dihydrate 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.

STORAGE: Store at 36° - 77°F (2° - 25°C).

NOTE: LUER-LOK is a registered trademark of Becton, Dickinson & Co.

Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA
©2003, 2013,2015 Novartis

Alcon®
a Novartis company

9012632-1115

label
label

NDC 0065-0795-15

BSS®

STERILE IRRIGATING SOLUTION

(BALANCED SALT SOLUTION)

UNIT DOSE 15 mL

Rx Only

ALCON LABORATRIES, INC.
FORT WORTH
TEXAS 76134 USA

289010-0902

label
label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
806396BSS Sterile Irrigating 0.048 % / 0.03 % / 0.075 % / 0.39 % / 0.64 % / 0.17 % Ophthalmic SolutionPSN15
806392calcium chloride 0.048 % / magnesium chloride 0.03 % / potassium chloride 0.075 % / sodium acetate 0.39 % / sodium chloride 0.64 % / sodium citrate 0.17 % Ophthalmic SolutionPSN15
806396calcium chloride 0.004 MEQ/ML / magnesium chloride 0.003 MEQ/ML / potassium chloride 0.01 MEQ/ML / sodium acetate 0.0475 MEQ/ML / sodium chloride 0.109 MEQ/ML / sodium citrate 0.012 MEQ/ML Ophthalmic Solution [BSS Ophthalmic Solution]SBD15
806392calcium chloride 0.004 MEQ/ML / magnesium chloride 0.003 MEQ/ML / potassium chloride 0.01 MEQ/ML / sodium acetate 0.0475 MEQ/ML / sodium chloride 0.109 MEQ/ML / sodium citrate 0.012 MEQ/ML Ophthalmic SolutionSCD15
806396BSS Ophthalmic Solution (calcium chloride 0.004 MEQ/ML / magnesium chloride 0.003 MEQ/ML / potassium chloride 0.01 MEQ/ML / sodium acetate 0.0475 MEQ/ML / sodium chloride 0.109 MEQ/ML / sodium citrate 0.012 MEQ/ML) Ophthalmic SolutionSY15
806396BSS Ophthalmic Solution (calcium chloride 0.048 % / magnesium chloride 0.03 % / potassium chloride 0.075 % / sodium acetate 0.39 % / sodium chloride 0.64 % / sodium citrate 0.17 % ) Ophthalmic SolutionSY15
806392Calcium Chloride 0.004 MEQ/ML / Magnesium Chloride 0.003 MEQ/ML / K+ Chloride 0.01 MEQ/ML / Sodium Acetate 0.0475 MEQ/ML / NaCl 0.109 MEQ/ML / sodium citrate 0.012 MEQ/ML Ophthalmic SolutionSY15
806396Calcium Chloride 0.004 MEQ/ML / Magnesium Chloride 0.003 MEQ/ML / K+ Chloride 0.01 MEQ/ML / Sodium Acetate 0.0475 MEQ/ML / NaCl 0.109 MEQ/ML / sodium citrate 0.012 MEQ/ML Ophthalmic Solution [BSS Ophthalmic Solution]SY15
806392Calcium Chloride 0.004 MEQ/ML / Magnesium Chloride 0.003 MEQ/ML / Pot Chloride 0.01 MEQ/ML / Sodium Acetate 0.0475 MEQ/ML / NaCl 0.109 MEQ/ML / sodium citrate 0.012 MEQ/ML Ophthalmic SolutionSY15
806396Calcium Chloride 0.004 MEQ/ML / Magnesium Chloride 0.003 MEQ/ML / Pot Chloride 0.01 MEQ/ML / Sodium Acetate 0.0475 MEQ/ML / NaCl 0.109 MEQ/ML / sodium citrate 0.012 MEQ/ML Ophthalmic Solution [BSS Ophthalmic Solution]SY15
806392calcium chloride 0.048 % / magnesium chloride 0.03 % / potassium chloride 0.075 % / sodium acetate 0.39 % / sodium chloride 0.64 % / sodium citrate 0.17 % Ophthalmic SolutionSY15

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813
POTASSIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-0795-15BSS15 mL in 1 BOTTLESOLUTION1515
0065-0795-25BSS250 mL in 1 BOTTLESOLUTION25015
0065-0795-30BSS30 mL in 1 BOTTLESOLUTION3015
0065-0795-50BSS500 mL in 1 BOTTLESOLUTION50015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0795BSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]15Current NDC, Legacy NDC, 4 package rows20240126_4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0795-15ML - Milliliter0065-079504c6c8c3-1cff-44af-9611-b5397819e53112012-07-24
0065-0795-25ML - Milliliter0065-0795c1c97f31-1a6e-4960-bdf4-de0b1d97b7e212012-07-24
0065-0795-30ML - Milliliter0065-079530fcb579-c0e7-45b5-ba35-389d5a0aea9a12012-07-24
0065-0795-50ML - Milliliter0065-0795ebe55ae5-887b-4331-8628-9056e287e3b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM CHLORIDEACTIVE INGREDIENTM4I0D6VV5M2
MAGNESIUM CHLORIDEACTIVE INGREDIENT02F3473H9O2
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I102
SODIUM ACETATEACTIVE INGREDIENT4550K0SC9B2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X2
SODIUM CITRATEACTIVE INGREDIENT1Q73Q2JULR2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB2
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8382
POTASSIUM CATIONACTIVE MOIETY295O53K1522
SODIUM CATIONACTIVE MOIETYLYR4M0NH372
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0065-07950065-0795-15, 0065-0795-30, 0065-0795-25, 0065-0795-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / OPHTHALMIC0.31 %w/vExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / OPHTHALMIC0.31 %w/vExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / OPHTHALMIC0.31 %w/vExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / OPHTHALMIC0.31 %w/vExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / OPHTHALMIC0.31 %w/vExact identifier — unii+route+dosage form
5 equally ranked IID candidates

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
N020742-001BSSCALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020742-001AT

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 22:38:342026-08N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-1084e616aacf4f…
2026-08-18 06:07:402026-07N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020742-001BSS0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLSOLUTION / IRRIGATIONATRLD, RS1997-12-10f41ea6bd6efb…

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 22:38:342026-08N020742-001AT184e616aacf4f…
2026-08-18 06:07:402026-07N020742-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020742-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020742-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020742-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020742-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020742-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020742-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020742-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020742-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020742-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020742-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020742-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020742-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020742-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020742-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020742-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020742-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020742-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020742-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020742-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020742-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020742-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N020742-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020742-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020742-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020742-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N020742-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020742-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020742-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020742-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020742-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020742-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020742-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020742-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020742-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020742-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020742-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020742-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020742-001AT1f41ea6bd6efb…

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
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
ndc (package): 0065-0795-50
ndc (package): 0065-0795-30
ndc (package): 0065-0795-25
ndc (package): 0065-0795-15
ndc (product): 0065-0795
ndc11 (package): 00065079530
ndc11 (package): 00065079515
ndc11 (package): 00065079525
ndc11 (package): 00065079550
spl id: f56f90e2-cd68-445b-b8fb-74a53f0f2ca6
spl set id: 4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea

Reported adverse events (FAERS/openFDA)#

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