FDA.reportPublic FDA data

cool and heat pain relieving liquid

Product NDC
69452-375
11-digit product format
694520375
Labeler code
69452
Product ID
69452-375_29f91a1d-7cce-3cab-e063-6394a90a0274
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Bionpharma Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-01
Substance
MENTHOL
Active strength
16 mg/100mL
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
cool and heat pain relieving liquid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL16 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec6f59d8-45c5-46a0-e053-2995a90a239fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-375-96cool and heat pain relieving liquid1 in 1 CARTONLIQUID12
69452-375-96cool and heat pain relieving liquid74 mL in 1 CONTAINERLIQUID742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-375COOL AND HEAT PAIN RELIEVING LIQUID (MENTHOL) LIQUID [BIONPHARMA INC.]2Current NDC, Legacy NDC, 2 package rows20241225_ec6f59d8-45c5-46a0-e053-2995a90a239f.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 75 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kalaya Extra Strength Pain Relief Cream with Hemp Seed OilMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp2eccf23c-fae2-423c-9cae-549bc41941042025-10-08WarningsExact identifier
application number: M017
KALAYA BACK AND NECK PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp48fd73e7-1443-4ac7-bf7c-d99bf2449f512025-10-08WarningsExact identifier
application number: M017
Lidocaine Pain Relieving PatchLIDOCAINE 4%BluePoint Laboratories3117273d-e006-2726-e063-6294a90a9c332025-10-08WarningsExact identifier
application number: M017
EQUATE PAIN RELIEVING PATCHESLIDOCAINE 4%WALMART, INC01e1cc0e-e1c9-d274-e063-6294a90a409e2025-10-08WarningsExact identifier
application number: M017
Equate Pain Relief BalmMENTHOL 11%, CAMPHOR 11% OINTMENTWALMART, INCd8ddf835-f008-ce1f-e053-2a95a90aa9b32025-10-08WarningsExact identifier
application number: M017
TheraCare Pain Relieving Menthol GelMENTHOL 2%Veridian Healthcare9d2ccb02-746c-4cb9-905d-280987778f4d2025-10-08WarningsExact identifier
application number: M017
COOLING PAIN RELIEFMENTHOL, CAMPHORSUNSET NOVELTIES, INC3a9019b1-8798-1ef9-e063-6394a90a09a42025-10-08WarningsExact identifier
application number: M017
Coralite Capsaicin Heat Patch 2ctCAPSAICINUnited Exchange Corp.4128b1ac-f540-2611-e063-6294a90ac98b2025-10-08WarningsExact identifier
application number: M017
Ombre Men overtime wipesBENZOCAINESambria Pharmaceuticals, LLC405f23ca-99c1-4db4-aba1-2fd7f93f55ee2025-10-07WarningsExact identifier
application number: M017
Pain free IVLIDOCAINESambria Pharmaceuticals, LLC7aa4cb20-d452-417f-afdb-307df754ed752025-10-07WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONECVS PHARMACY, INCb3bdff5e-37fe-442a-a370-7b19799ea7812025-10-07WarningsExact identifier
application number: M017
HealthWise Pain Relief PatchMENTHOL, METHYL SALICYLATEVeridian Healthcareb65932fd-ee9f-4fa2-b842-01e0f54133c92025-10-07WarningsExact identifier
application number: M017
AREX SINSIN PASCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.2013ea44-e2ea-4b36-bddb-7f64163284b62025-10-07WarningsExact identifier
application number: M017
SINSINPAS LIDOCAINE PAIN RELIEVINGLIDOCAINESinsin Pharmaceutical Co., Ltd.82c0a036-8750-5b3d-e053-2a91aa0a18152025-10-07WarningsExact identifier
application number: M017
SINSIN MULPASL-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR, CHLORPHENIRAMINE MALEATE, THYMOLSinsin Pharmaceutical Co., Ltd.81baffcb-c08e-4616-e053-2a91aa0aaf152025-10-07WarningsExact identifier
application number: M017
Arex Sinsin PasCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.a851854a-5dfe-4bd5-95f6-67c3f13f11872025-10-07WarningsExact identifier
application number: M017
Sinsinpas Arex Flex Gel Pain Relieving PatchL-MENTHOLSinsin Pharmaceutical Co., Ltd.1758ef9b-4fac-4066-e063-6394a90a8cc32025-10-07WarningsExact identifier
application number: M017
SINSINPAS CORN REMOVERSALICYLIC ACIDSinsin Pharmaceutical Co., Ltd.e2771dfc-ee57-553f-e053-2a95a90af2812025-10-07WarningsExact identifier
application number: M017
CapsaicinCAPSAICINPHARMACURE LLC05a09ee5-e7a4-4758-8b16-f60b945a7d822025-10-06WarningsExact identifier
application number: M017
LidocannaLIDOCAINEPHARMACURE LLCb28ebbb6-1112-4750-a2bb-f96b03fabe6e2025-10-06WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-375-96694520375961 CONTAINER in 1 CARTON (69452-375-96) / 74 mL in 1 CONTAINER1 container2022-11-010000-00-00NoNoCurrent