MEDISTIK DUAL HOT AND COLD

Product NDC
50231-511
11-digit product format
502310511
Labeler code
50231
Product ID
50231-511_3edd4cdd-70b2-80ee-e063-6294a90af4a0
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate, Menthol
Dosage form
SPRAY
Route
TOPICAL
Labeler
Natureteq Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-19
Substance
MENTHOL; METHYL SALICYLATE
Active strength
10; 12 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct50231-511EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage50231-51150231-511-11EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
MEDISTIK DUAL HOT AND COLD
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL10 g/100mL
METHYL SALICYLATE12 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1738566Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba5f4626-f077-4a28-8dcc-dacd50741eadAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50231-511-11MEDISTIK DUAL HOT AND COLD118 mL in 1 BOTTLESPRAY11817

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50231-511MEDISTIK DUAL HOT AND COLD (METHYL SALICYLATE, MENTHOL) SPRAY [NATURETEQ INC.]16Current NDC, Legacy NDC, 1 package rows20250108_ba5f4626-f077-4a28-8dcc-dacd50741ead.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 78 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Asper FlexLIDOCAINEAkron Pharma Inc.06ddae64-cda7-4eb9-872f-5182c83cb00c2025-09-19WarningsExact identifier
application number: M017
Good Neighbor Pain Relief Patch With Lidocaine 4%LIDOCAINEAmerisource Bergen5f5cc887-d479-4c9a-affc-49d0c331f7422025-09-18WarningsExact identifier
application number: M017
TheraCare Roll-on Lidocaine Pain Relief LiquidLIDOCAINE HCIVeridian Healthcaree942d447-754d-4683-9c99-57c7e83d7ea82025-09-18WarningsExact identifier
application number: M017
TheraCare Roll-on Lidocaine Pain Relief Liquid - LavenderLIDOCAINE HCIVeridian Healthcare6bebce76-30f6-4070-b0fe-58246d0713282025-09-18WarningsExact identifier
application number: M017
HealthWise Roll-On Lidocaine Pain Relief LiquidLIDOCAINE HCIVeridian Healthcare1133f6d4-f4c0-4ce9-e063-6394a90a5f4e2025-09-18WarningsExact identifier
application number: M017
InkKulture NumbingLIDOCAINE HCLProdigy Media Inc85a64315-dfa5-4f23-9f61-1cce694ea6bd2025-09-17WarningsExact identifier
application number: M017
Ink Scribd NumbingLIDOCAINE HCLProdigy Media Inc54173858-aff0-43b2-bc7b-c4ecab9bc3e52025-09-17WarningsExact identifier
application number: M017
Inkorporated NumbingLIDOCAINE HCLProdigy Media Inc3017056c-f3c6-4300-8344-bf6e7d32e8702025-09-17WarningsExact identifier
application number: M017
TattooGirl NumbingLIDOCAINE HCLProdigy Media Inc6abe4540-f6c9-412a-83f3-682df77150572025-09-17WarningsExact identifier
application number: M017
Dr Tatty NumbingLIDOCAINE HCLProdigy Media Inc5bb558c1-bf8f-4956-8732-e19720f62f312025-09-17WarningsExact identifier
application number: M017
Burn Ease CoolingLIDOCAINEProStat First Aid LLCec201ca1-efa0-4797-aec3-115647c29abd2025-09-17WarningsExact identifier
application number: M017
MedFreeze Naturally Cool Pain ReliefMENTHOLMEDKO LLC240f2346-c585-4334-997c-45db6268d7c42025-09-15WarningsExact identifier
application number: M017
MEDISTIK DUAL HOT AND COLDMETHYL SALICYLATE, MENTHOLNatureteq Inc.ba5f4626-f077-4a28-8dcc-dacd50741ead2025-09-15WarningsExact identifier
application number: M017
ndc (product): 50231-511
MEDISTIK ICEMENTHOL, CAMPHORNatureteq Inc.c1077744-7b9a-4536-8faf-e21994a43ea52025-09-15WarningsExact identifier
application number: M017
Caring Mills Vaginal Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcarecd379e74-2841-47e4-b95a-de1b341b397f2025-09-15WarningsExact identifier
application number: M017
Lidocaine-Pain-Relief-PatchLIDOCAINE-PAIN-RELIEF-PATCHHenan Enokon Medical Instrument Co., Ltd.3ecfa867-50f6-d98a-e063-6394a90aefa02025-09-14WarningsExact identifier
application number: M017
Meijer Hydrocortsione CreamHYDROCORTSIONE CREAM 1%Meijer Distribution Inc.1cbddb7e-f2e3-0951-e063-6394a90a3d372025-09-12WarningsExact identifier
application number: M017
JO Prolonger with BenzocaineBENZOCAINECC Wellness LLCd955f612-1267-f1be-e053-2995a90a53452025-09-12WarningsExact identifier
application number: M017
JO for Him Prolonger with LidocaineLIDOCAINECC Wellness LLCb12dc6a3-142d-3219-e053-2995a90aead02025-09-12WarningsExact identifier
application number: M017
Walgreens Medicated Foot PowderMENTHOLDavion, Inc58e1e7f7-6284-411f-9765-0e63eabca0f32025-09-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738566menthol 10 % / methyl salicylate 12 % Topical SprayPSNba5f4626-f077-4a28-8dcc-dacd50741ead17
1738566menthol 100 MG/ML / methyl salicylate 120 MG/ML Topical SpraySCDba5f4626-f077-4a28-8dcc-dacd50741ead17
1738566menthol 10 % / methyl salicylate 12 % Topical SpraySYba5f4626-f077-4a28-8dcc-dacd50741ead17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50231-511-1150231051111118 mL in 1 BOTTLE (50231-511-11) 118 ml2016-02-190000-00-00NoNoCurrent