> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/fluorescein-sodium-1363526c-c45b-44b2-909d-fb7d05a6ea09
> Record changed: 2026-10-13

# Fluorescein sodium

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1628233)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1628233)

First approval year

1976

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1628233)

## Development status

**First approval year**

1976

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1628233)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1628233)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1628233)

**Drug name**

Fluorescein sodium

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1628233)

**Molecular weight**

376.28

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1628233)

**Structure (SMILES)**

O=C(\[O-\])c1ccccc1-c1c2ccc(=O)cc-2oc2cc(\[O-\])ccc12.\[Na+\].\[Na+\]

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1628233)

### Brand names (10)

- fluor amps
- Fluor-amps
- fluorescite
- Fluorescite
- fluorets
- Fluorets
- funduscein 25
- Funduscein-25
- retinofluor
- Retinofluor

### Other names (65)

- acid yellow 73 sodium salt
- Acid yellow 73 sodium salt
- benzoic acid 2 6 hydroxy 3 oxo 3h xanthen 9 yl disodium salt
- BENZOIC ACID, 2-(6-HYDROXY-3-OXO-3H-XANTHEN-9-YL)-, DISODIUM SALT
- c i 45350
- c i acid yellow 73
- C.i. 45350
- C.i. acid yellow 73
- ci 45350
- Ci 45350
- d c yellow no 8
- D&C YELLOW NO. 8
- fluorescein disodium salt
- Fluorescein disodium salt
- FLUORESCEIN DISODIUM SALT \[MI\]
- fluorescein disodium salt mi
- fluorescein sodium
- Fluorescein sodium
- FLUORESCEIN SODIUM \[EP IMPURITY\]
- FLUORESCEIN SODIUM \[EP MONOGRAPH\]
- FLUORESCEIN SODIUM \[JAN\]
- FLUORESCEIN SODIUM \[MART.\]
- FLUORESCEIN SODIUM \[ORANGE BOOK\]
- FLUORESCEIN SODIUM \[USP MONOGRAPH\]
- FLUORESCEIN SODIUM \[VANDF\]

And 40 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 518-47-8

**ChEMBL ID**

CHEMBL1628233

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1628233)

**InChIKey**

NJDNXYGOVLYJHP-UHFFFAOYSA-L

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1628233)

**RxNorm IDs (RxCUI)**

- 57789

**FDA ingredient codes (UNII)**

- 93X55PE38X

### PubChem compound IDs (2)

- 10608
- 3680403

## Regulatory information

### United States

**Applicant**

ALCON LABS INC

**Approval date**

28 Mar 2006

**Application number**

NDA021980

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

#### Administration routes

- Parenteral
- topical

### Investigated indications (4)

- **Condition**  
Skin Diseases

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000701

**Subject identifier**  
D012871
- **Condition**  
Hyperemia

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003822

**Subject identifier**  
D006940
- **Condition**  
Neuroma, Acoustic

**Highest recorded phase**  
2

**Condition identifier**  
HP:0009588

**Subject identifier**  
D009464
- **Condition**  
Heart Septal Defects, Atrial

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0007172

**Subject identifier**  
D006344

### Open Targets indications (3)

- **Condition identifier**  
EFO\_0000701

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0009588

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0007172

**Highest recorded phase**  
1

### Reported adverse events (37)

- **Event**  
age-related macular degeneration

**Reports**  
2

**Reporting signal score**

6.37111
- **Event**  
anaphylactic reaction

**Reports**  
21

**Reporting signal score**

39.0265
- **Event**  
anaphylactic shock

**Reports**  
32

**Reporting signal score**

101.261
- **Event**  
blood pressure decreased

**Reports**  
15

**Reporting signal score**

26.3935
- **Event**  
cardio-respiratory arrest

**Reports**  
7

**Reporting signal score**

17.6946
- **Event**  
chest discomfort

**Reports**  
17

**Reporting signal score**

24.8342
- **Event**  
chills

**Reports**  
11

**Reporting signal score**

10.2521
- **Event**  
circulatory collapse

**Reports**  
4

**Reporting signal score**

6.51957
- **Event**  
cold sweat

**Reports**  
7

**Reporting signal score**

15.8902
- **Event**  
consciousness fluctuating

**Reports**  
2

**Reporting signal score**

7.22526
- **Event**  
contrast media allergy

**Reports**  
4

**Reporting signal score**

15.3898
- **Event**  
dizziness

**Reports**  
20

**Reporting signal score**

7.44692
- **Event**  
drug hypersensitivity

**Reports**  
20

**Reporting signal score**

13.6685
- **Event**  
dysphonia

**Reports**  
6

**Reporting signal score**

6.96251
- **Event**  
dyspnoea

**Reports**  
26

**Reporting signal score**

11.4439
- **Event**  
feeling hot

**Reports**  
6

**Reporting signal score**

7.55562
- **Event**  
haemangioma congenital

**Reports**  
7

**Reporting signal score**

35.8888
- **Event**  
hyperhidrosis

**Reports**  
16

**Reporting signal score**

19.8513
- **Event**  
hypersensitivity

**Reports**  
14

**Reporting signal score**

11.5297
- **Event**  
laryngeal oedema

**Reports**  
9

**Reporting signal score**

27.721
- **Event**  
larynx irritation

**Reports**  
2

**Reporting signal score**

9.77382
- **Event**  
loss of consciousness

**Reports**  
15

**Reporting signal score**

15.9669
- **Event**  
low birth weight baby

**Reports**  
7

**Reporting signal score**

18.1757
- **Event**  
nausea

**Reports**  
52

**Reporting signal score**

38.3137
- **Event**  
palpitations

**Reports**  
12

**Reporting signal score**

13.5443

And 12 more, listed on the interactive page.

### Trial references (5)

- NCT01959230  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01959230)
- NCT01959243  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01959243)
- NCT02519920  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02519920)
- NCT03189134  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03189134)
- NCT04351373  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04351373)

## Chemical properties

**Hydrogen bond acceptors**

5

**Hydrogen bond donors**

2

**Polar surface area**

75.99

**Calculated partition coefficient (ALogP)**

3.67

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

0

**Heavy atoms**

27

**Molecular formula**

C20H10Na2O5

**Monoisotopic mass**

376.03236198

**Natural product**

No

## National Drug Codes

- 0065-0092
- 24208-734
- 51801-003
- 51801-008
- 51801-009
- 54288-179
- 59390-205
- 59390-218
- 82260-734
- 83851-100
- 51662-1533
- 70710-2045
- 70710-2046
- 70771-1969
- 70771-1970
- 81298-8660

## Evidence counts

**Recorded assays**

16

**Active assays**

0

## Pharmacologic actions

- Contrast Media  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D003287.html)
- Fluorescent Dyes  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D005456.html)

## Related records

### Trials (146)

- "Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Drug B10-FC After Single Administration to Adult Patients".
- 3 Adjuvated Reduced Dose IPV-Al SSI Vaccines and Non-adjuvated Full Dose IPV SSI, as Booster Vaccination to Adolescents
- A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components
- A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream"
- A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)
- A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%
- A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
- A Food Effect Study of CT-L01 After Oral Administration in Healthy Volunteers
- A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease
- A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)
- A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)
- A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)
- A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age
- A Pharmacokinetic (PK) Study to Compare the Absorption of Two Formulations of Transdermal Testosterone Spray and Intrinsa®
- A Phase I Study to Assess Novel Cream in a Psoriasis Plaque Test
- A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Lot Consistency Trial)
- A Study Comparing Oxymetazoline 1% Cream to RHOFADE
- [A Study Comparing Tapinarof Cream 1% and Vtama® Cream 1% in the Treatment of Plaque Psoriasis.](https://trialight.com/data/trial/a-study-comparing-tapinarof-cream-1-and-vtama-cream-1-in-the-b7e05f34-7d79-45f1-9537-74aa307bb47e.md)
- A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD
- A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)

### In development for (3)

- Acoustic neuroma Phase 2
- Atrial septal defect 1 Phase 1
- [Skin disorder](https://trialight.com/data/condition/skin-disorder-c8e27943-0efd-5c2b-abce-01c2ef37e853.md) Phase 2

---

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