BURBLE

Product NDC
83557-001
11-digit product format
835570001
Labeler code
83557
Product ID
83557-001_5c42e36d-642f-f90a-e063-6294a90a852e
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM CHLORIDE
Dosage form
TABLET, FOR SOLUTION
Route
NASAL
Labeler
LETS BURBLE, INC.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-08
Substance
SODIUM CHLORIDE; CALCIUM BICARBONATE
Active strength
2860; 65 mg/1; mg/1
Pharmacologic classes
Alkalinizing Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
BURBLE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE2860 mg/1
CALCIUM BICARBONATE65 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct 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
83557-001-30BURBLE30 in 1 BAGTABLET, FOR SOLUTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83557-001BURBLE (SODIUM CHLORIDE) TABLET, FOR SOLUTION [LETS BURBLE, INC.]2Current NDC, 1 package rows20241213_17f48d4f-907c-3829-e063-6394a90ab202.zip

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 7 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vis Guard Lubricant Eye DropsPOLYVINYL ALCOHOL 1.4%Ulai Health LLCe9b0ed39-60c8-1093-e053-2a95a90a705b2026-01-13WarningsExact identifier
application number: M018
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb4697319-438e-2ec8-e053-2a95a90abb562026-01-08WarningsExact identifier
application number: M018
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb478a695-ded0-2e5f-e053-2995a90ac45e2026-01-08WarningsExact identifier
application number: M018
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
application number: M018
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
application number: M018
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
application number: M018
Polyvinyl Alcohol Eye Drops 1,4 % w/vPOLYVINYL ALCOHOL EYE DROPS 1,4 % W/VAurolabe8e09719-6e06-612b-e053-2995a90a79fc2026-01-08WarningsExact identifier
application number: M018
AuroviscHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolabe9100312-b105-50a6-e053-2a95a90ac31f2026-01-08WarningsExact identifier
application number: M018
TheraTears Dry and TiredCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC02b70e2d-8159-4637-a282-9eac1468e7862026-01-07WarningsExact identifier
application number: M018
VISTA Hypromellose Dry Eye ReliefHYPROMELLOSERed Wedding LLCb2c4954c-ed53-778a-e053-2a95a90ae0d02026-01-01WarningsExact identifier
application number: M018
Colirio Ojo De Aguila Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEGrandall Distributing Co., Inc.31aa07e9-0cc9-2a77-e063-6394a90a4b9d2025-12-31WarningsExact identifier
application number: M018
Value Health by Prodose Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Prodose, Inc.3fafa362-a8a6-3f91-e063-6394a90a98b32025-12-31WarningsExact identifier
application number: M018
Signature Care Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands LLC6f1f4f58-3208-4b06-9afb-c4beeed093142025-12-30WarningsExact identifier
application number: M018
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporation6c449374-8847-4c4a-9073-1951ff31d4042025-12-30WarningsExact identifier
application number: M018
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporationddc15dac-fbd8-42fa-80db-79f49fc6b9eb2025-12-30WarningsExact identifier
application number: M018
Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMAmerisource Bergen Drug Corp.fd6b2be8-7e00-3765-e053-6294a90a40612025-12-30WarningsExact identifier
application number: M018
Rugby Carboxymethylcellulose Sodium 0.5% Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratoriesfb84fc0b-9a62-812a-e053-6394a90aba0a2025-12-30WarningsExact identifier
application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye DropsPOLYVINYL ALCOHOLRugby Laboratories081673b2-5c74-1200-e063-6394a90ae3632025-12-30WarningsExact identifier
application number: M018
Medi-First Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMUnifirst First Aid Corporationa4e651cc-adf0-af9e-e053-2995a90ace5a2025-12-30WarningsExact identifier
application number: M018
Green Guard Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMUniFirst First Aid Corporationc3f04fdb-9fc1-797d-e053-2995a90afe802025-12-30WarningsExact identifier
application number: M018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83557-001-01835570001011 BAG in 1 BOX (83557-001-01) / 30 TABLET, FOR SOLUTION in 1 BAG1 bag2024-05-08NoNoCurrent
83557-001-05835570001051 BAG in 1 BOX (83557-001-05) / 5 TABLET, FOR SOLUTION in 1 BAG1 bag2024-05-08NoNoCurrent
83557-001-308355700013030 TABLET, FOR SOLUTION in 1 BAG (83557-001-30) 2024-05-08NoNoCurrent