FDA.reportPublic FDA data

Tetracaine HCL

Product NDC
54288-127
11-digit product format
542880127
Labeler code
54288
Product ID
54288-127_df1a3d1f-8d9c-4ae6-9cad-527680105425
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracaine HCL
Dosage form
INJECTION
Route
SUBARACHNOID
Labeler
BPI LABS LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-06-26
Substance
TETRACAINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tetracaine HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRACAINE HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5NF5D4OPCIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198248Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b3349c1-bd02-4442-9bf0-40a654bb8a80Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-127-01Tetracaine HCL2 mL in 1 VIALINJECTION29
54288-127-10Tetracaine HCL10 in 1 BOXINJECTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-127-01ML - Milliliter54288-127e92b1025-15af-42c1-b3ed-88261b44ca4812020-09-14
54288-127-10ML - Milliliter54288-127571e6a3d-2227-4e77-a9cf-aa0078d460b612020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-127TETRACAINE HCL INJECTION [BPI LABS LLC]8Current NDC, Legacy NDC, 2 package rows20250213_2b3349c1-bd02-4442-9bf0-40a654bb8a80.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
Tetracaine HCLTETRACAINE HCLBPI LABS LLC2b3349c1-bd02-4442-9bf0-40a654bb8a802025-12-17Warnings, Adverse reactionsExact identifier
ndc (product): 54288-127

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198248tetracaine HCl 20 MG in 2 ML InjectionPSN2b3349c1-bd02-4442-9bf0-40a654bb8a809
1982482 ML tetracaine hydrochloride 10 MG/ML InjectionSCD2b3349c1-bd02-4442-9bf0-40a654bb8a809
198248tetracaine hydrochloride 20 MG per 2 ML InjectionSY2b3349c1-bd02-4442-9bf0-40a654bb8a809

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54288-127-01542880127012 mL in 1 VIAL2 mlHistorical
54288-127-105428801271010 VIAL in 1 BOX (54288-127-10) / 2 mL in 1 VIAL (54288-127-01) 10 vial2020-06-260000-00-00NoNoCurrent