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 117 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Flexible Pain Relieving LidocaineLIDOCAINE, MENTHOLWalgreen Co.6f070fa3-a61a-4523-a470-ab58bf9400a32024-11-27WarningsExact identifier
application number: M017
Benadryl Original Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC920c50cb-9bdd-4a36-bb3d-c2559db733272024-11-26WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC884907a8-c884-4cce-ac10-9d4848fdba3e2024-11-22WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC7f067e95-e01c-4b9a-a02e-0af097beb18c2024-11-22WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC9ece9b3a-0092-4c1c-a913-c2fefcd705412024-11-22WarningsExact identifier
application number: M017
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1936c5f4-274b-8e49-e063-6394a90ac6422024-11-21WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief Cream Platinum 4% LidocaineLIDOCAINE 4%Telebrands Corp2788189e-35bc-d48c-e063-6294a90ae6c22024-11-21WarningsExact identifier
application number: M017
Family Wellness Ultra Strength Muscle RubULTRA STRENGTH MUSCLE RUBFAMILY DOLLAR (Family Wellness)554c7d3c-09f4-4923-b4ca-d5de8f7e2c9a2024-11-21WarningsExact identifier
application number: M017
Family Wellness Anorectal LidocaineANORECTAL LIDOCAINEFAMILY DOLLAR (Family Wellness)ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d2024-11-21WarningsExact identifier
application number: M017
Family Wellness Hot and Cold Pain ReliefHOT AND COLD PAIN RELIEFFAMILY DOLLAR (Family Wellness)b70e343b-18aa-4e45-ae8e-79d8c84ad2052024-11-21WarningsExact identifier
application number: M017
Signature Care Lidocaine CreamLIDOCAINEBetter Living Brands LLC5483729e-ef1a-47a2-b7cf-c19744f520732024-11-21WarningsExact identifier
application number: M017
WINCO HydrocortisoneHYDROCORTISONE 1%WinCo Foods LLC26a29de3-4b79-4a3a-93b6-a14c5e91a8c62024-11-21WarningsExact identifier
application number: M017
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEDynarex Corporationd0e43651-4215-465b-9ace-1bc23126b1092024-11-20WarningsExact identifier
application number: M017
Hempvana Cold As Ice Pain Relief Gel-PatchMENTHOLTelebrands Corp976a1bb2-b776-8199-e053-2995a90a1a1b2024-11-20WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain ReliefTROLAMINE SALICYLATETELEBRANDS CORPd91a0fad-a38c-1580-e053-2a95a90ad2682024-11-20WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief - PlatinumTROLAMINE SALICYLATETELEBRANDS CORPd58da6c5-47a6-b8a8-e053-2995a90a7ce72024-11-20WarningsExact identifier
application number: M017
Hempvana Knee Bird Ultra Strength Pain ReliefLIDOCAINE, MENTHOLTELEBRANDS CORPdf5d3312-cbc5-5db9-e053-2995a90ab0552024-11-20WarningsExact identifier
application number: M017
Hempvana Cold as Ice GelMENTHOLTelebrands Corpa9e103f2-778f-e49b-e053-2a95a90aa8b72024-11-20WarningsExact identifier
application number: M017
Hempvana Knee Bird Ultra Strength Pain ReliefLIDOCAINE, MENTHOLTELEBRANDS CORPd58e2c47-c0f4-625e-e053-2a95a90aa4d52024-11-20WarningsExact identifier
application number: M017
Hempvana Pain ReliefTROLAMINE SALICYLATETelebrands Corp92a29553-a102-0a0e-e053-2a95a90ab24a2024-11-20WarningsExact 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