FDA.reportPublic FDA data

NDC 68678-053 - BIOEASE PAIN RELIEVING COLD THERAPY

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68678-053
Package NDCs from labels
68678-053-03
Manufacturer
AHC Ventures Corp DBA Cryoderm
Effective date
2014-02-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BIOEASE PAIN RELIEVING COLD THERAPY - AHC Ventures Corp DBA CryodermAHC Ventures Corp DBA Cryoderm2014-02-02HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68678-053-032019-11-27C16284748780-19855e2a2-4cda-60a7-e053-dbdaa90a05bdBIOEASE® Pain Relieving Cold Therapy Roll-On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68678-053-03BIOEASE PAIN RELIEVING COLD THERAPY95 mL in 1 BOTTLEGEL952

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68678-053BIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]21 package rows20140203_3ad3724b-898d-43cf-bc45-72795eb20b0a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q941BIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
MENTHOLACTIVE INGREDIENTL7T10EIP3ABIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q941BIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
MENTHOLACTIVE MOIETYL7T10EIP3ABIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LBIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FBIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2
WATERINACTIVE INGREDIENT059QF0KO0RBIOEASE PAIN RELIEVING COLD THERAPY (MENTHOL, CAMPHOR) GEL [AHC VENTURES CORP DBA CRYODERM]2

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 38 of 207 · 4,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLOld East Main Co.2a09f6c0-e9a6-4f48-bce1-6cf7345f2d872026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLOld East Main Co.3e7a7f3e-3e99-4999-95c2-1603aca08e892026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
50% RubbingISOPROPYL ALCOHOLOld East Main Co.2b600254-2a70-4254-85fb-29b9adb56c9a2026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Therapain PlusMENTHOL ROLL-ONEpic Laboratories, LLC0249cfdf-b7c4-f27d-e063-6294a90aaa262026-03-02WarningsExact identifier
unii: L7T10EIP3A
Lightning Pain ReliefMENTHOLClinical Resolution Laboratory, Inc.80af21f5-dba8-42b0-8a65-ac5a94d83ca82026-03-02WarningsExact identifier
unii: L7T10EIP3A
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLTARGET Corporationc49f46c5-f9b2-4045-a31d-63cb222102332026-03-02WarningsExact identifier
unii: ND2M416302
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
unii: PDC6A3C0OX
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLSam's West, Inca9d6778a-e5ad-4e02-9142-4a932540eda72026-03-02WarningsExact identifier
unii: ND2M416302
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: PDC6A3C0OX
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLChain Drug Marketing Association27ff8499-63e0-49ad-a4dd-dde6da584f932026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLChain Drug Marketing Association1c4b22aa-4f2b-8f30-e063-6394a90a6ed52026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLChain Drug Marketing Associationbd8a4b8b-cd59-4d0d-8ceb-40bba777e61b2026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Mouth RinseEUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOLThe Kroger Co.d97cdb55-c6bc-4138-ad1d-c7124d7f5cec2026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Kroger Co.116146db-719f-4c48-8a8a-1120ea62b0d52026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: N20HL7Q941
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLThe Kroger Co.e4844ad3-6073-4c2c-9029-5c4f4ea024e82026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar control plusEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLThe Kroger Co.0407d06e-a8d4-4522-8213-3a7a0c5e336e2026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
MEDISTIK PROFESSIONAL DUAL ACTIONMENTHOL, METHYL SALICYLATE, EUCALUPTUSNatureteq Inc.99c7f08a-ab14-4371-9147-189f75cb66332026-02-27WarningsExact identifier
unii: L7T10EIP3A
Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLThe Kroger Co.f6ccdce2-ae3c-44f7-803d-5a135a7a7e8e2026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalmart Inc.a8daefba-b985-4ef9-b900-e5647324662e2026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METYL SALICYLATE, THYMOLWalmart Inc.404dfa0f-8ac1-463a-9e10-fc87f70697952026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.