North Star Nutritionals Soothanol X3 Pain Relieving Drops

Product NDC
50972-950
11-digit product format
509720950
Labeler code
50972
Product ID
50972-950_525231f9-8d5d-ac0b-e063-6394a90ace35
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
NEWMARKET HEALTH PRODUCTS, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-08
Substance
MENTHOL
Active strength
130 mg/mL
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
North Star Nutritionals Soothanol X3 Pain Relieving Drops
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL130 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2743526Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
068343b8-0435-40d0-846c-9d8624e8b6c4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50972-950-00North Star Nutritionals Soothanol X3 Pain Relieving Drops30 mL in 1 BOTTLELIQUID301

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 18 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze Overnight Roll-onMENTHOLReckitt Benckiser LLCf67d7b7a-8922-73f6-e053-2995a90a2e802026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight ReliefMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC07be6e88-1850-4d6a-946d-f03830b8c4a22026-05-15WarningsExact identifier
application number: M017
Biofreeze Roll-On and Overnight Roll-OnMENTHOLReckitt Benckiser LLC4d3dcb8f-2075-6bbc-e063-6394a90a49922026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6bef9ccb-7a5a-4c67-b1bc-a92b167312da2026-05-15WarningsExact identifier
application number: M017
Biofreeze Roll-OnMENTHOLReckitt Benckiser LLCebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb2026-05-15WarningsExact identifier
application number: M017
Biofreeze Precision Relief PenMENTHOLReckitt Benckiser LLCb4cc1db5-a33f-17bc-e053-2995a90ab7eb2026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCdb982baf-31ea-4f09-90e3-cd5facb5dfe52026-05-15WarningsExact identifier
application number: M017
Biofreeze Professional Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCf62f8ec3-593d-480a-85a0-01fcd7f1790c2026-05-15WarningsExact identifier
application number: M017
PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ONMENTHOLReckitt Benckiser LLC8af185ad-719e-4684-89c0-9c17c12774992026-05-15WarningsExact identifier
application number: M017
PERFORM COOL and SOOTHING PAIN RELIEVINGMENTHOLReckitt Benckiser LLCef158f63-2d75-47a3-b94a-2d821d5118632026-05-15WarningsExact identifier
application number: M017
KY Duration for HimLIDOCAINEReckitt Benckiser LLC83cc86bd-3303-4956-a198-fae85b6e34e12026-05-15WarningsExact identifier
application number: M017
4% LIDOCAINE PATCHES4% LIDOCAINEShenzhen Huayuan Hengsheng Technology Co., Ltd.4f53cfd3-a7c4-e308-e063-6294a90ad6982026-05-14WarningsExact identifier
application number: M017
Cold and Heat Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLCardinal Health, 110 dba LEADER77066d01-75b0-4a8d-88d3-c639626d33262026-05-14WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnLIDOCAINETrifecta Pharmaceuticals USA51cb6797-55ec-7a7a-e063-6294a90a90ee2026-05-14WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnMENTHOLTrifecta Pharmaceuticals USA51b403dc-fc9b-0cad-e063-6394a90af0812026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC5edddb99-6596-4a3b-b361-1cc04d032c312026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC684faf63-5e44-4471-8384-e8fa7c0d842a2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC4c798b06-6ee5-41d1-8a14-f6889512ade32026-05-13WarningsExact identifier
application number: M017
BIOFREEZEMENTHOLReckitt Benckiser LLC83d5c2f2-2413-4d28-83b2-0808d0917b4d2026-05-13WarningsExact identifier
application number: M017
Scalpicin Anti-Itch Maximum StrengthHYDROCORTISONEReckitt Benckiser LLC7b1a29fa-b266-43e6-a87b-aa3c96ab40412026-05-13WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2743526menthol 13 % Topical SolutionPSN068343b8-0435-40d0-846c-9d8624e8b6c41
2743526menthol 130 MG/ML Topical SolutionSCD068343b8-0435-40d0-846c-9d8624e8b6c41
2743526menthol 13 % Topical SolutionSY068343b8-0435-40d0-846c-9d8624e8b6c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50972-950-005097209500030 mL in 1 BOTTLE (50972-950-00) 30 ml2026-05-08NoNoCurrent