FDA.reportPublic FDA data

BSS

Product NDC
0065-0795
11-digit product format
000650795
Labeler code
0065
Product ID
0065-0795_f56f90e2-cd68-445b-b8fb-74a53f0f2ca6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
balanced salt solution
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
NDA020742
Marketing category
NDA
Marketing start
1969-03-28
Substance
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE
Active strength
.48; .3; .75; 3.9; 6.4; 1.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BSS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CHLORIDE.48 mg/mL
MAGNESIUM CHLORIDE.3 mg/mL
POTASSIUM CHLORIDE.75 mg/mL
SODIUM ACETATE3.9 mg/mL
SODIUM CHLORIDE6.4 mg/mL
SODIUM CITRATE1.7 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM4I0D6VV5M, 02F3473H9O, 660YQ98I10, 4550K0SC9B, 451W47IQ8X, 1Q73Q2JULR
Rxcui806392, 806396

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
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334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
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0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
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
0065-0795-25BSS250 mL in 1 BOTTLESOLUTION2502
0065-0795-50BSS500 mL in 1 BOTTLESOLUTION5002

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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CHLORIDEACTIVE INGREDIENTM4I0D6VV5MBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2
MAGNESIUM CHLORIDEACTIVE INGREDIENT02F3473H9OBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10BSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2
SODIUM ACETATEACTIVE INGREDIENT4550K0SC9BBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2
SODIUM CITRATEACTIVE INGREDIENT1Q73Q2JULRBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838BSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2
POTASSIUM CATIONACTIVE MOIETY295O53K152BSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2
SODIUM CATIONACTIVE MOIETYLYR4M0NH37BSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2
CALCIUM CHLORIDEACTIVE INGREDIENTM4I0D6VV5MBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]1
MAGNESIUM CHLORIDEACTIVE INGREDIENT02F3473H9OBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]1
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10BSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]1
SODIUM ACETATEACTIVE INGREDIENT4550K0SC9BBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]1
SODIUM CITRATEACTIVE INGREDIENT1Q73Q2JULRBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838BSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]1
POTASSIUM CATIONACTIVE MOIETY295O53K152BSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37BSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]1

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
0065-0795BSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]2Current NDC, Legacy NDC, 2 package rows20160309_d2f55b3f-0873-4536-aedb-2829a91927c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
806396BSS Sterile Irrigating 0.048 % / 0.03 % / 0.075 % / 0.39 % / 0.64 % / 0.17 % Ophthalmic SolutionPSN4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea15
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 SolutionPSN4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea15
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]SBD4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea15
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 SolutionSCD4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea15
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 SolutionSY4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea15
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 SolutionSY4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea15
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 SolutionSY4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea15
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]SY4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea15
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 SolutionSY4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea15
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]SY4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea15
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 SolutionSY4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea15
806396BSS Sterile Irrigating 0.048 % / 0.03 % / 0.075 % / 0.39 % / 0.64 % / 0.17 % Ophthalmic SolutionPSNd2f55b3f-0873-4536-aedb-2829a91927c72
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 SolutionPSNd2f55b3f-0873-4536-aedb-2829a91927c72
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]SBDd2f55b3f-0873-4536-aedb-2829a91927c72
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 SolutionSCDd2f55b3f-0873-4536-aedb-2829a91927c72
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 SolutionSYd2f55b3f-0873-4536-aedb-2829a91927c72
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 SolutionSYd2f55b3f-0873-4536-aedb-2829a91927c72
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 SolutionSYd2f55b3f-0873-4536-aedb-2829a91927c72
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]SYd2f55b3f-0873-4536-aedb-2829a91927c72
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 SolutionSYd2f55b3f-0873-4536-aedb-2829a91927c72
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]SYd2f55b3f-0873-4536-aedb-2829a91927c72
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 SolutionSYd2f55b3f-0873-4536-aedb-2829a91927c72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0065-0795-150006507951515 mL in 1 BOTTLE (0065-0795-15) 15 ml1969-03-280000-00-00NoNoCurrent
0065-0795-2500065079525250 mL in 1 BOTTLE250 mlHistorical
0065-0795-300006507953030 mL in 1 BOTTLE30 mlHistorical
0065-0795-5000065079550500 mL in 1 BOTTLE (0065-0795-50) 500 ml1969-03-280000-00-00NoNoCurrent