Theraworx Nerve Relief Foam

Product NDC
61594-020
11-digit product format
615940020
Labeler code
61594
Product ID
61594-020_fa2348f9-1227-b787-e053-6394a90a4863
Type
HUMAN OTC DRUG
Nonproprietary name
ONION, HYPERICUM PERFORATUM WHOLE, SANGUINARIA CANADENSIS ROOT
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
AVADIM HOLDINGS, INC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-02-01
Substance
HYPERICUM PERFORATUM WHOLE; ONION; SANGUINARIA CANADENSIS ROOT
Active strength
10; 10; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Theraworx Nerve Relief Foam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYPERICUM PERFORATUM WHOLE10 [hp_X]/mL
ONION10 [hp_X]/mL
SANGUINARIA CANADENSIS ROOT8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXK4IUX8MNB, 492225Q21H, N9288CD508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61594-020-00Theraworx Nerve Relief Foam210 mL in 1 BOTTLEAEROSOL, FOAM2103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61594-020THERAWORX NERVE RELIEF FOAM (ONION, HYPERICUM PERFORATUM WHOLE, SANGUINARIA CANADENSIS ROOT) AEROSOL, FOAM [AVADIM HOLDINGS, INC.]3Current NDC, Legacy NDC, 1 package rows20230426_9ed7d5fc-ad84-499b-a774-feedf21ca8d4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61594-020-0061594002000210 mL in 1 BOTTLE (61594-020-00) 210 ml2022-02-010000-00-00NoNoCurrent