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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE40 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61594-044-00Theraworx PM Nighttime Maximum Strength Pain Relief1 in 1 CARTONLIQUID12
61594-044-00Theraworx PM Nighttime Maximum Strength Pain Relief74 mL in 1 BOTTLELIQUID742

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61594-044-00ML - Milliliter61594-044c0b6419a-4f81-47b1-b6ba-bcde30b7386212024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61594-044THERAWORX PM NIGHTTIME MAXIMUM STRENGTH PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) LIQUID [AVADIM HOLDINGS, INC.]2Current NDC, 2 package rows20240921_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 117 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MYCO Clinic Pain ReliefMENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions604a30c9-2306-47a1-bd31-94b63639dd902024-11-20WarningsExact identifier
application number: M017
MYCO Clinic Pain ReliefCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions0b489420-3b5c-43c5-aab4-0e3720acf9ce2024-11-20WarningsExact identifier
application number: M017
MYCO Clinic Pain ReliefCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsdd906129-a787-4352-856d-d7a915031a6e2024-11-20WarningsExact identifier
application number: M017
Walgreens Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDEWalgreens Company80d3031a-7fa9-4f5b-b85e-c7c6ef3148012024-11-20WarningsExact identifier
application number: M017
Anti-Itch Medicated Maximum StrengthBENZOCAINE AND RESORCINOLWalgreens Company7fd86dcb-edef-4d0d-b389-7ecea595fe672024-11-20WarningsExact identifier
application number: M017
Walgreens Pain ReliefBENZOCAINEWalgreens Company7cee7234-32cd-4bf3-8a6c-0882585eec7f2024-11-20WarningsExact identifier
application number: M017
Walgreens Advanced Scar GelADVANCED SCAR GELWalgreens Company2c040475-a124-485c-933e-66b452f5ab462024-11-20WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEClinic Pharma274611ea-7fc2-ba3f-e063-6294a90aa50f2024-11-19WarningsExact identifier
application number: M017
First Aid Only Sting Relief PadBENZOCAINEAcme United Corporation5087cbbd-1bbe-62ed-e054-00144ff8d46c2024-11-19WarningsExact identifier
application number: M017
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLAcme United Corporation6bb9a782-2394-4c8c-e053-2991aa0a08d42024-11-19WarningsExact identifier
application number: M017
First Aid Only Sting ReliefBENZOCAINEAcme United Corporation697127d1-c02e-16d2-e053-2a91aa0a39fd2024-11-19WarningsExact identifier
application number: M017
First Aid Only Hydrocortisone 1% Anti-ItchHYDROCORTISONEAcme United Corporatione5597b11-b08e-99e1-e053-2a95a90a15a52024-11-19WarningsExact identifier
application number: M017
Equate Cold Therapy Pain Relieving Roll-on AnalgesicMENTHOL, UNSPECIFIED FORMWal-Mart Stores, Inc.4115f0ac-e12a-4e59-94f5-a47dcc7f87662024-11-18WarningsExact identifier
application number: M017
Equate Cold Therapy Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMWal-Mart Stores, Inc.ac6c2112-8692-4628-97d8-3a5a9f5097662024-11-18WarningsExact identifier
application number: M017
Equate Odor-Free Therapy Arthritis AnalgesicTROLAMINE SALICYLATEWal-Mart Stores, Inc.1d73e7b6-c7f9-4680-b3e3-a954b91e18632024-11-18WarningsExact identifier
application number: M017
First Aid Only BurnLIDOCAINE HYDROCHLORIDEAcme United Corporation9af39fcd-0a57-26d0-e053-2a95a90a99a02024-11-17WarningsExact identifier
application number: M017
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEAcme United Corporationcaa67a05-bdbd-c380-e053-2995a90a0bf12024-11-17WarningsExact identifier
application number: M017
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafewayc6b9c4e1-bab8-490d-8c00-c43377ad08572024-11-15WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreen Company1a9b8b4c-3e15-49e6-af91-76ed0dc0829e2024-11-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSNbc8cb476-9a47-47b3-ad78-a6ecec9ee66f2
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCDbc8cb476-9a47-47b3-ad78-a6ecec9ee66f2
1987647lidocaine hydrochloride 4 % Topical SolutionSYbc8cb476-9a47-47b3-ad78-a6ecec9ee66f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61594-044-00615940044001 BOTTLE in 1 CARTON (61594-044-00) / 74 mL in 1 BOTTLE1 bottle2024-09-01NoNoCurrent