Theraworx Relief Joint Discomfort and Inflammation

Product NDC
61594-013
11-digit product format
615940013
Labeler code
61594
Product ID
61594-013_1b2fea8c-49c9-62eb-e063-6394a90adb5e
Type
HUMAN OTC DRUG
Nonproprietary name
FRANKINCENSE
Dosage form
LIQUID
Route
TOPICAL
Labeler
AVADIM HOLDINGS, INC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-01
Substance
FRANKINCENSE
Active strength
8 [hp_X]/210mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Theraworx Relief Joint Discomfort and Inflammation
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FRANKINCENSE8 [hp_X]/210mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R9XLF1R1WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
37c297f6-6b3e-495c-9f72-9327e0638cc5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61594-013-03Theraworx Relief Joint Discomfort and Inflammation101 mL in 1 BOTTLELIQUID1017
61594-013-07Theraworx Relief Joint Discomfort and Inflammation210 mL in 1 BOTTLELIQUID2107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61594-013THERAWORX RELIEF JOINT DISCOMFORT AND INFLAMMATION (FRANKINCENSE) LIQUID [AVADIM HOLDINGS, INC.]7Current NDC, Legacy NDC, 2 package rows20240619_37c297f6-6b3e-495c-9f72-9327e0638cc5.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraworx Relief Joint Discomfort and InflammationFRANKINCENSEAVADIM HOLDINGS, INC.37c297f6-6b3e-495c-9f72-9327e0638cc52024-06-18WarningsExact identifier
ndc (product): 61594-013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61594-013-0361594001303101 mL in 1 BOTTLE (61594-013-03) 101 ml2020-07-110000-00-00NoNoCurrent
61594-013-0761594001307210 mL in 1 BOTTLE (61594-013-07) 210 ml2020-07-110000-00-00NoNoCurrent