FDA.reportPublic FDA data

Theraworx Pain Relief Roll- On- Lidocaine

Product NDC
61594-028
11-digit product format
615940028
Labeler code
61594
Product ID
61594-028_08645940-ca97-3f2b-e063-6394a90a386f
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
2024-01-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Theraworx Pain Relief Roll- On- Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1987647

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
61594-028-00Theraworx Pain Relief Roll- On- Lidocaine1 in 1 CARTONLIQUID11
61594-028-00Theraworx Pain Relief Roll- On- Lidocaine74 mL in 1 BOTTLELIQUID741

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61594-028-00ML - Milliliter61594-0280d447cd4-8d89-4f96-b2ad-82f8ca3183b112024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61594-028THERAWORX PAIN RELIEF ROLL- ON- LIDOCAINE (LIDOCAINE HYDROCHLORIDE) LIQUID [AVADIM HOLDINGS, INC.]1Current NDC, 2 package rows20240115_b4ce3876-f9e3-43ca-810b-75fbe6f887b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSNb4ce3876-f9e3-43ca-810b-75fbe6f887b61
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCDb4ce3876-f9e3-43ca-810b-75fbe6f887b61
1987647lidocaine hydrochloride 4 % Topical SolutionSYb4ce3876-f9e3-43ca-810b-75fbe6f887b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61594-028-00615940028001 BOTTLE in 1 CARTON (61594-028-00) / 74 mL in 1 BOTTLE1 bottle2024-01-15NoNoCurrent