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 96 of 203 · 4,046 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8529596f-37e4-c44e-e053-2a91aa0ad0142025-10-30WarningsExact identifier
unii: ND2M416302
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
unii: L7T10EIP3A
RELISPRAY NATURAL PAIN RELIEFMENTHOLMidas-Care Pharmaceuticals, Pvt. Ltdadc8a43c-19a1-4eb3-9820-b63f7b5e91ea2025-10-30WarningsExact identifier
unii: L7T10EIP3A
GlycerinGLYCERINChain Drug Marketing Association Inc.424d91f0-ecf9-6d9b-e063-6394a90a80062025-10-29WarningsExact identifier
unii: PDC6A3C0OX
Aromalief Pain Relief Cream Orange GingerMENTHOLMarketites LLC9e8d3611-ef1b-4ac6-e053-2995a90af28a2025-10-29WarningsExact identifier
unii: L7T10EIP3A
Aromalief Calming Pain Relief Cream LavenderMENTHOLMarketites LLCb8197d52-ccfb-b008-e053-2995a90a0a532025-10-29WarningsExact identifier
unii: L7T10EIP3A
Aromalief Cozy Vanilla Pain Relief CreamMENTHOLMarketites LLC3634e55e-8c62-a782-e063-6394a90a65082025-10-29WarningsExact identifier
unii: L7T10EIP3A
WorkvieLIDOCAINE HCL, MENTHOLMarketites LLCaebaffb5-58dd-ebd5-e053-2a95a90a14ed2025-10-29WarningsExact identifier
unii: L7T10EIP3A
BENOVA PAIN AND ITCH RELIEFMENTHOL, 0.11%BENOVA RX LLC42513ee2-8b40-a9f3-e063-6394a90a93862025-10-29WarningsExact identifier
unii: L7T10EIP3A
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8578da30-a155-2505-e053-2991aa0a2c042025-10-29WarningsExact identifier
unii: ND2M416302
Coralite Ultra Strength Pain ReliefCAMPHOR MENTHOLUnited Exchange Corp.44ecf959-cc07-4adc-a500-075b2ee695482025-10-29WarningsExact identifier
unii: L7T10EIP3A
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMPublix Super Markets Inc354a640c-bc7e-45c8-9df0-8b5b01767f5c2025-10-29WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CALMADOLCAMPHOR, MENTHOL, METHYL SALICYLATEGRANDALL DISTRIBUTING, LLC31b7f84e-8b66-4d31-8e9c-279d0af2fe642025-10-28WarningsExact identifier
unii: L7T10EIP3A
unii: N20HL7Q941
XRay DOLCAMPHOR, MENTHOL, AND METHYL SALICYLATEGenomma Lab USA, Inc.e07fef46-68d9-769c-e053-2a95a90aa0652025-10-28WarningsExact identifier
unii: L7T10EIP3A
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: PDC6A3C0OX
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: PDC6A3C0OX
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)MY IMPORTS USA LLC421d7bd9-c893-ec97-e063-6394a90a4b282025-10-27WarningsExact identifier
unii: ND2M416302
PRMENTHOLAmphp, Inc6f5b9e08-c445-4fac-e053-2a91aa0aa7372025-10-27WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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