Home NDC 50231-511 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 50231-511 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 50231-511 50231-511-11 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…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 Ingredient Strength MENTHOL 10 g/100mL METHYL SALICYLATE 12 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup LAV5U5022Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1738566 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50231-511-11 MEDISTIK DUAL HOT AND COLD 118 mL in 1 BOTTLE SPRAY 118 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50231-511 MEDISTIK DUAL HOT AND COLD (METHYL SALICYLATE, MENTHOL) SPRAY [NATURETEQ INC.] 16 Current NDC, Legacy NDC, 1 package rows 20250108_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 148 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EMU THERAPY Red Hot Pepper Pain Relief Cream MENTHOL, CAPSAICIN ACA MANAGEMENT LLC 36293885-b2dd-4fba-9748-35a3c9e05078 2023-11-06 Warnings Exact identifier application number: M017 ROPANA Pain Relief Cream HISTAMINE DIHYDROCHLORIDE FUSION PAIN SOLUTIONS LLC e0342aa3-ca80-40b7-bec6-1b33c4db398b 2023-11-06 Warnings Exact identifier application number: M017 EMU THERAPY Cool Menthol Therapy Pain Relief Cream MENTHOL ACA MANAGEMENT LLC 16894346-3513-41b1-b09f-72d84edcc4ac 2023-11-06 Warnings Exact identifier application number: M017 SKINS DELAY Climax Control Lidocaine LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 0db91010-12f7-4f20-b96c-432915720d5a 2023-11-06 Warnings Exact identifier application number: M017 POWERECT Lidocaine Male Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 42e0c40f-1efd-45ef-815d-53d193d720eb 2023-11-06 Warnings Exact identifier application number: M017 ARTHRO LIFE Instant Pain Relief Cream MENTHOL BIOBEST SERVICES LLC 66eb1a78-6861-4693-b68e-bd4a664fc075 2023-11-06 Warnings Exact identifier application number: M017 PARACTIN QuantumActiv Pain Relief Cream MENTHOL NHR SCIENCE CORP ae2f89cf-120c-4c6f-9e81-4560e6fa0373 2023-11-06 Warnings Exact identifier application number: M017 FISICO Arthrozene Pain Cream MENTHOL FISICO INC. d02c4349-78dd-4672-9582-50124ea9f1e1 2023-11-06 Warnings Exact identifier application number: M017 BRONSON SOOTHE Pain Relief CAPSAICIN BRONSON NUTRITIONALS, LLC cedf8f43-b9a3-4a06-b3a1-cf82668541f8 2023-11-06 Warnings Exact identifier application number: M017 INTIMALE Benzocaine Delay Gel BENZOCAINE SKINS SEXUAL HEALTH LIMITED b845bfd5-ab73-495f-97ef-e959bc6311d9 2023-11-06 Warnings Exact identifier application number: M017 RAPID PAIN-RELIEF TOPICAL LIDOCAINE HYDROCHLORIDE, MENTHOL NORDIC HEALTHY LIVING INC. a06d6aca-9aa2-4bbe-bf77-4c85f1dd7870 2023-11-06 Warnings Exact identifier application number: M017 PURE PERSONAL All Natural Pain Relief Cream MENTHOL PURE PERSONAL CARE, LLC 8f3fb1d0-d238-4b4c-9816-7e335258d71d 2023-11-06 Warnings Exact identifier application number: M017 DIRT Pain Relieving Gel MENTHOL PURIVITAE, LLC 89c80a8f-227d-4ec0-9327-683892e73b6a 2023-11-06 Warnings Exact identifier application number: M017 DIRT Pain Relieving Gel MENTHOL PURIVITAE, LLC e43e2cbd-d114-4b11-8baf-7a775881cd97 2023-11-06 Warnings Exact identifier application number: M017 Celadrin Joint and Muscle Pain Relieving MENTHOL Factors Group of Nutritional Products 6396e4b6-2130-433b-bdb3-97c76dbe685c 2023-11-06 Warnings Exact identifier application number: M017 Atomic Balm METHYL SALICYLATE, CAPSAICIN The Hygenic Company, LLC d10028f3-ae6a-7b01-e053-2995a90a5a84 2023-11-05 Warnings Exact identifier application number: M017 HEMPCIN Advanced Topical Pain Relief Cream MENTHOL Pedicis Research, LLC 97f5e300-b780-4694-a681-60d5e0cfad65 2023-11-05 Warnings Exact identifier application number: M017 Point Relief cold Spot Pain Relieving roll-on MENTHOL Fabrication Enterprises 3f1db0ad-aaa8-4e14-9349-45057e0fb4a6 2023-11-05 Warnings Exact identifier application number: M017 LidoStat LIDOCAINE HCL Clinical Therapeutic Solutions 1825885b-9141-4515-bb69-a1c4a39fb10d 2023-11-05 Warnings Exact identifier application number: M017 Point Relief Cold Spot Pain Relieving MENTHOL Fabrication Enterprises 391af69f-74aa-48cf-bc96-75e5c4e0e445 2023-11-05 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50231-511-11 50231051111 118 mL in 1 BOTTLE (50231-511-11) 118 ml 2016-02-19 0000-00-00 No No Current