TetraVisc Forte

Product NDC
54799-504
11-digit product format
547990504
Labeler code
54799
Product ID
54799-504_e9e4ea89-71c4-4591-9bf2-00ebeb53a522
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracaine Hydrochloride
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
OCuSOFT, INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-08-25
Marketing end
0000-00-00
Substance
TETRACAINE HYDROCHLORIDE
Active strength
25 mg/5mL
Pharmacologic classes
Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct54799-504DDiscontinued by firm2026-08-11
excluded productproduct54799-504DDiscontinued by firm2026-08-11
excluded packagepackage54799-50454799-504-05DDiscontinued by firm2026-08-11
excluded packagepackage54799-50454799-504-01DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54799-504-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54799-504-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54799-504-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54799-504-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54799-504-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54799-504-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54799-504-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54799-504-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54799-504-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54799-504-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54799-504-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54799-504-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54799-504-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54799-504-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54799-504-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54799-504-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54799-504-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54799-504-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54799-504-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54799-504-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54799-504-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54799-504-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54799-504-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54799-504-05557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54799-504-01EA - Each54799-50475a88ff5-323b-479f-b560-daa4243136af12012-07-24
54799-504-05ML - Milliliter54799-504a4ad8be6-ae97-4b77-bd92-7527facdedbc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Tetracaine HydrochlorideACTIVE INGREDIENT5NF5D4OPCITETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]12
TetracaineACTIVE MOIETY0619F35CGVTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]12
Boric AcidINACTIVE INGREDIENTR57ZHV85D4TETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]12
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]12
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]12
HypromellosesINACTIVE INGREDIENT3NXW29V3WOTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]12
Potassium ChlorideINACTIVE INGREDIENT660YQ98I10TETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]12
Sodium BorateINACTIVE INGREDIENT91MBZ8H3QOTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]12
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]12
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ITETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]12
WaterINACTIVE INGREDIENT059QF0KO0RTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]12
Tetracaine HydrochlorideACTIVE INGREDIENT5NF5D4OPCITETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]4
TetracaineACTIVE MOIETY0619F35CGVTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]4
Boric AcidINACTIVE INGREDIENTR57ZHV85D4TETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]4
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]4
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]4
HypromellosesINACTIVE INGREDIENT3NXW29V3WOTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]4
Potassium ChlorideINACTIVE INGREDIENT660YQ98I10TETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]4
Sodium BorateINACTIVE INGREDIENT91MBZ8H3QOTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]4
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]4
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ITETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]4
WaterINACTIVE INGREDIENT059QF0KO0RTETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]4