Home NDC 51452-035 Point Relief Cold Spot Pain Relieving
Product NDC 51452-035
11-digit product format 514520035
Labeler code 51452
Product ID 51452-035_0fc4ec9e-6c21-5a8c-e063-6394a90a11ef
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form GEL
Route TOPICAL
Labeler Fabrication Enterprises
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-01
Substance MENTHOL
Active strength 120 mg/mL
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Point Relief Cold Spot Pain Relieving
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 120 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2121666 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 51452-035-01 Point Relief Cold Spot Pain Relieving 120 mL in 1 BOTTLE GEL 120 4 51452-035-02 Point Relief Cold Spot Pain Relieving 475 mL in 1 BOTTLE GEL 475 4 51452-035-03 Point Relief Cold Spot Pain Relieving 3800 mL in 1 JUG GEL 3800 4 51452-035-04 Point Relief Cold Spot Pain Relieving 420 mL in 1 TUBE GEL 420 4 51452-035-05 Point Relief Cold Spot Pain Relieving 950 mL in 1 BOTTLE GEL 950 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51452-035 POINT RELIEF COLD SPOT PAIN RELIEVING (MENTHOL) GEL [FABRICATION ENTERPRISES] 4 Current NDC, Legacy NDC, 5 package rows 20240126_ad5d6f04-15e6-4548-95c2-32271c186bc1.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 106 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Green Compass Reduce Pain Relief CAMPHOR, MENTHOL, METHYL SALICYLATE Green Compass, Inc. 0a0b688e-50f1-3eb1-e063-6394a90a7efa 2025-01-01 Warnings Exact identifier application number: M017 Green Compass Reduce Topical Pain CAMPHOR, MENTHOL, METHYL SALICYLATE Green Compass, Inc. 8cb80362-5d24-1ee3-e053-2a95a90afcdf 2025-01-01 Warnings Exact identifier application number: M017 Green Compass Reduce Roll-On Pain Relief MENTHOL Green Compass, Inc. b5916aa2-428c-5637-e053-2995a90a08b0 2025-01-01 Warnings Exact identifier application number: M017 OKeeffes Working Hands Pain Relief Skin Protectant ALLANTOIN, LIDOCAINE HYDROCHLORIDE The Gorilla Glue Company/O'Keeffe's Company 0685da25-c9fa-e1cd-e063-6394a90ae1b3 2025-01-01 Warnings Exact identifier application number: M017 Icy Hot with Lidocaine Pain Relieving LIDOCAINE HCL AND MENTHOL Chattem, Inc. 75b28b06-77ea-4fea-b516-2e8a0dac7037 2025-01-01 Warnings Exact identifier application number: M017 Advanced Seal Barrier plus Pain Relief LIDOCAINE Kericure Inc. 7ac95325-e6e9-4c56-9315-876c00af7c98 2025-01-01 Warnings Exact identifier application number: M017 FixMySkin Healing Balm Fragrance-Free HYDROCORTISONE Lovely Skin, Inc. c12af4c6-2f05-46ec-b901-1a4fcd750180 2024-12-31 Warnings Exact identifier application number: M017 Pain Relieving Cream Lidocaine BENZYL ALCOHOL, LIDOCAINE HCI Trifecta Pharmaceuticals USA LLC 039a2036-54b2-cf28-e063-6294a90a8ce6 2024-12-31 Warnings Exact identifier application number: M017 Cold Therapy Pain Relief Walgreens MENTHOL 10.5% WALGREEN COMPANY f1daa68d-1b12-c28a-e053-2995a90a0949 2024-12-31 Warnings Exact identifier application number: M017 Calypxo Pain Relief METHYL SALICYLATE, MENTHOL Advanced Rx of Tennessee, LLC 0b7736df-c7e0-7d00-e063-6294a90aa57e 2024-12-31 Warnings Exact identifier application number: M017 New Terocin METHYL SALICYLATE, CAPSAICIN, AND MENTHOL Advanced Rx Pharmacy of Tennessee, LLC f4bfc4a6-06ef-1f76-e053-2995a90a2b8f 2024-12-31 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Advanced Rx Pharmacy of Tennessee, LLC 01cb19a4-ce22-144d-e063-6294a90a8aa3 2024-12-31 Warnings Exact identifier application number: M017 Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream LIDOCAINE, MENTHOL Sato Pharmaceutical Co., Ltd. 2251e96b-d050-4ec2-a6b9-6659610885bf 2024-12-30 Warnings Exact identifier application number: M017 hydrocortisone HYDROCORTISONE Safeway af2e2ef3-0f3f-4592-8081-b6553ade2f5a 2024-12-26 Warnings Exact identifier application number: M017 Comforte Menstrual Cramp Relief Cream MENTHOL PMS4PMS LLC c121537e-3333-4f35-8c77-20086158dff4 2024-12-26 Warnings Exact identifier application number: M017 N-Labs Arcticzen Pain Relief Knee CAMPHOR (SYNTHETIC), MENTHOL NUTRIOMO LABS PTE. LTD 05ee574a-854c-4a77-be77-082055075c4d 2024-12-26 Warnings Exact identifier application number: M017 BiteMD External Analgesic First Aid Antiseptic BENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOL United Industries Corporation 4c60db03-6d2b-4ae0-a200-718b3a50eb0f 2024-12-23 Warnings Exact identifier application number: M017 GNP Anti Itch CAMPHOR, MENTHOL AMERISOURCEBERGEN DRUG CORPORATION b4f2d6f7-2287-47d8-e053-2995a90ae335 2024-12-23 Warnings Exact identifier application number: M017 cool and heat pain relieving liquid MENTHOL Bionpharma Inc. ec6f59d8-45c5-46a0-e053-2995a90a239f 2024-12-23 Warnings Exact identifier application number: M017 FOOT WORKS MAXIMUM CRACKED HEEL BENZALKONIUM CHLORIDE, LIDOCAINE COSMAX USA, CORPORATION 29f92230-d1d4-5e94-e063-6294a90af812 2024-12-23 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 51452-035-01 51452003501 120 mL in 1 BOTTLE (51452-035-01) 120 ml 2019-04-01 0000-00-00 No No Current 51452-035-02 51452003502 475 mL in 1 BOTTLE (51452-035-02) 475 ml 2019-04-01 0000-00-00 No No Current 51452-035-03 51452003503 3800 mL in 1 JUG (51452-035-03) 3800 ml 2019-04-01 0000-00-00 No No Current 51452-035-04 51452003504 420 mL in 1 TUBE (51452-035-04) 420 ml 2019-04-01 0000-00-00 No No Current 51452-035-05 51452003505 950 mL in 1 BOTTLE (51452-035-05) 950 ml 2019-04-01 0000-00-00 No No Current