FDA.reportPublic FDA data

C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips

Product NDC
83851-100
11-digit product format
838510100
Labeler code
83851
Product ID
83851-100_386aaf96-81c0-bd6f-e063-6394a90ad761
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluorescein Sodium
Dosage form
STRIP
Route
OPHTHALMIC
Labeler
Vistamerica USA
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-10-01
Substance
FLUORESCEIN SODIUM
Active strength
1 mg/mg
Pharmacologic classes
Diagnostic Dye [EPC], Dyes [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUORESCEIN SODIUM1 mg/mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
93X55PE38XInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
292abb69-84ad-4f61-e063-6394a90a1447Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f43a274-9585-47cb-b427-0eb3e578384dProduct name120250623
4a998fa9-995e-4ea5-97ef-93a559305758Product name120200706
c94ccba7-2a03-4a3e-a891-d62a57340fb2Product name120180215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83851-100-05C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips50 in 1 BOXSTRIP502
83851-100-05C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips1 mg in 1 PACKETSTRIP12
83851-100-10C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips100 in 1 BOXSTRIP1002
83851-100-10C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips1 mg in 1 PACKETSTRIP12
83851-100-30C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips300 in 1 BOXSTRIP3002
83851-100-30C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips1 mg in 1 PACKETSTRIP12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83851-100-30EA - Each83851-100abd99e11-a506-45fb-affc-00160498546412025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83851-100C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS (FLUORESCEIN SODIUM) STRIP [VISTAMERICA USA]1Current NDC, 6 package rows20241215_292abb69-84ad-4f61-e063-6394a90a1447.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
C20H10Na2O5 Fluorescein Sodium Ophthalmic StripsFLUORESCEIN SODIUMVistamerica USA292abb69-84ad-4f61-e063-6394a90a14472025-06-01Exact identifier
ndc (product): 83851-100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83851-100-058385101000550 PACKET in 1 BOX (83851-100-05) / 1 mg in 1 PACKET50 packet2024-10-01NoNoCurrent
83851-100-1083851010010100 PACKET in 1 BOX (83851-100-10) / 1 mg in 1 PACKET100 packet2024-10-01NoNoCurrent
83851-100-3083851010030300 PACKET in 1 BOX (83851-100-30) / 1 mg in 1 PACKET300 packet2024-10-01NoNoCurrent