FDA.reportPublic FDA data

Theraworx Joint Relief Roll On

Product NDC
61594-027
11-digit product format
615940027
Labeler code
61594
Product ID
61594-027_0437aa5f-57f9-973a-e063-6294a90a9b30
Type
HUMAN OTC DRUG
Nonproprietary name
FRANKINCENSE
Dosage form
LIQUID
Route
TOPICAL
Labeler
AVADIM HOLDINGS, INC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-01-15
Substance
FRANKINCENSE
Active strength
8 [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FRANKINCENSE8 [hp_X]/mL

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
0437aa53-e3e7-0ac6-e063-6394a90a71ddAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61594-027-00Theraworx Joint Relief Roll On74 mL in 1 BOTTLELIQUID741
61594-027-00Theraworx Joint Relief Roll On1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61594-027THERAWORX JOINT RELIEF ROLL ON (FRANKINCENSE) LIQUID [AVADIM HOLDINGS, INC.]1Current NDC, 2 package rows20230901_0437aa53-e3e7-0ac6-e063-6394a90a71dd.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 Joint Relief Roll OnFRANKINCENSEAVADIM HOLDINGS, INC.0437aa53-e3e7-0ac6-e063-6394a90a71dd2023-08-31WarningsExact identifier
ndc (product): 61594-027

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61594-027-00615940027001 BOTTLE in 1 CARTON (61594-027-00) / 74 mL in 1 BOTTLE1 bottle2023-01-15NoNoCurrent