Home NDC 61594-044 Theraworx PM Nighttime Maximum Strength Pain Relief
Product NDC 61594-044
11-digit product format 615940044
Labeler code 61594
Product ID 61594-044_5d4f6c02-183f-001e-e063-6294a90a3b80
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE
Dosage form LIQUID
Route TOPICAL
Labeler AVADIM HOLDINGS, INC.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-01
Substance LIDOCAINE HYDROCHLORIDE
Active strength 40 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Theraworx PM Nighttime Maximum Strength Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1987647 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 61594-044-00 Theraworx PM Nighttime Maximum Strength Pain Relief 1 in 1 CARTON LIQUID 1 2 61594-044-00 Theraworx PM Nighttime Maximum Strength Pain Relief 74 mL in 1 BOTTLE LIQUID 74 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61594-044 THERAWORX PM NIGHTTIME MAXIMUM STRENGTH PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) LIQUID [AVADIM HOLDINGS, INC.] 2 Current NDC, 2 package rows 20240921_bc8cb476-9a47-47b3-ad78-a6ecec9ee66f.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 48 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 61594-044-00 61594004400 1 BOTTLE in 1 CARTON (61594-044-00) / 74 mL in 1 BOTTLE 1 bottle 2024-09-01 No No Current