Home NDC 54723-017 Painless Tattoo 3
Product NDC 54723-017
11-digit product format 547230017
Labeler code 54723
Product ID 54723-017_436c0c13-b4f8-ee4c-e063-6394a90a6c9f
Type HUMAN OTC DRUG
Nonproprietary name Tetracaine
Dosage form CREAM
Route TOPICAL
Labeler Sambria Pharmaceuticals, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-09-26
Substance TETRACAINE
Active strength 2 g/100mL
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 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 Painless Tattoo 3
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRACAINE 2 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0619F35CGV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1733865 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54723-017-01 Painless Tattoo 3 3 mL in 1 PACKET CREAM 3 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54723-017 PAINLESS TATTOO 3 (TETRACAINE) CREAM [SAMBRIA PHARMACEUTICALS, LLC] 3 Current NDC, 1 package rows 20240510_9c24dcff-3988-40eb-821a-fd4b0c85f528.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 78 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 54723-017-01 54723001701 3 mL in 1 PACKET (54723-017-01) 3 ml 2023-09-26 No No Current