FDA.reportPublic FDA data

BSS PLUS

Product NDC
0065-0800
11-digit product format
000650800
Labeler code
0065
Product ID
0065-0800_9bfcc79c-fa98-4800-b6ca-064544e74f2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
balanced salt solution enriched with bicarbonate, dextrose, and glutathione
Dosage form
KIT
Labeler
Alcon Laboratories, Inc.
Application
NDA018469
Marketing category
NDA
Marketing start
2013-06-20
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
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
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
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
0065-0800-94BSS PLUS1 in 1 PACKAGEKIT118
0065-0800-50BSS PLUS1 in 1 PACKAGEKIT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0800-25ML - Milliliter0065-0800ea2b9bf3-a0ef-4a7e-9a07-fb816e4907a312012-07-24
0065-0800-50ML - Milliliter0065-0800723c3934-6d6c-4581-a79e-e7b2cbc90a1512012-07-24
0065-0800-94ML - Milliliter0065-0800f4150100-1180-4551-a1b3-fe1455c0be9112016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Anhydrous DextroseACTIVE INGREDIENT5SL0G7R0OKBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
Calcium ChlorideACTIVE INGREDIENTM4I0D6VV5MBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
Magnesium ChlorideACTIVE INGREDIENT02F3473H9OBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
OxiglutationeACTIVE INGREDIENTULW86O013HBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
Potassium ChlorideACTIVE INGREDIENT660YQ98I10BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
Sodium BicarbonateACTIVE INGREDIENT8MDF5V39QOBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
Sodium ChlorideACTIVE INGREDIENT451W47IQ8XBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
Sodium Phosphate, DibasicACTIVE INGREDIENTGR686LBA74BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
Anhydrous DextroseACTIVE MOIETY5SL0G7R0OKBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
Bicarbonate IonACTIVE MOIETYHN1ZRA3Q20BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
Chloride IonACTIVE MOIETYQ32ZN48698BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
OxiglutationeACTIVE MOIETYULW86O013HBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
Phosphate IonACTIVE MOIETYNK08V8K8HRBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
WaterINACTIVE INGREDIENT059QF0KO0RBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]7
Calcium ChlorideACTIVE INGREDIENTM4I0D6VV5MBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1
DextroseACTIVE INGREDIENTIY9XDZ35W2BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1
Magnesium ChlorideACTIVE INGREDIENT02F3473H9OBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1
OxiglutationeACTIVE INGREDIENTULW86O013HBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1
Potassium ChlorideACTIVE INGREDIENT660YQ98I10BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1
Sodium BicarbonateACTIVE INGREDIENT8MDF5V39QOBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1
Sodium ChlorideACTIVE INGREDIENT451W47IQ8XBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1
Sodium Phosphate, DibasicACTIVE INGREDIENTGR686LBA74BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1
Calcium CationACTIVE MOIETY2M83C4R6ZBBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1
DextroseACTIVE MOIETYIY9XDZ35W2BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1
GlutathioneACTIVE MOIETYGAN16C9B8OBSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1
Magnesium CationACTIVE MOIETYT6V3LHY838BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1
Potassium CationACTIVE MOIETY295O53K152BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1
Sodium CationACTIVE MOIETYLYR4M0NH37BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0800BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]18Current NDC, Legacy NDC, 1 package rows20240126_9b6d7322-4a90-b31e-9fbb-f1fba1343608.zip
0065-0800BSS PLUS (BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE) KIT [ALCON LABORATORIES, INC.]11Current NDC, Legacy NDC, 1 package rows20240126_f69655c5-cf32-6461-e00e-3a5c4a761344.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0065-0800-50000650800501 KIT in 1 PACKAGE (0065-0800-50) * 480 mL in 1 BOTTLE, GLASS * 20 mL in 1 VIAL, SINGLE-DOSE1 kit1982-06-280000-00-00NoNoCurrent
0065-0800-94000650800941 KIT in 1 PACKAGE (0065-0800-94) * 480 mL in 1 BAG * 20 mL in 1 VIAL, GLASS1 kit2013-06-200000-00-00NoNoCurrent