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 102 of 203 · 4,046 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POMADA DRAGON PAIN RELIEVINGCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATETELEVISA CONSUMER PRODUCTS USAc283291d-feaa-4f89-8fde-9e3957ea8b9f2025-10-17WarningsExact identifier
unii: L7T10EIP3A
GlycerinGLYCERINChain Drug Consortium LLC4694f05b-d927-4e15-9630-a0a1cddb3cbb2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacye6a8914f-cfd9-4c72-abaa-22189bf0faef2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINChain Drug Marketing Association Inc.3386fada-6b7f-46fd-e063-6294a90abffc2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
Medline Alcohol Prep Sterile, LargeISOPROPYL ALCOHOLMedline Industries, LPc9fae7b6-2f4b-490b-9b17-a7297e7380692025-10-16WarningsExact identifier
unii: ND2M416302
Medline Alcohol Prep Sterile, MediumISOPROPYL ALCOHOLMedline Industries, LP9a8584e1-b422-4b77-8464-4e022d578fad2025-10-16WarningsExact identifier
unii: ND2M416302
Dollar General Menthol Pain Relief Gel RollonMENTHOLDolgencorp, LLC3a9b99e2-36b8-5dcf-e063-6394a90a382d2025-10-16WarningsExact identifier
unii: L7T10EIP3A
Medline Alcohol PrepISOPROPYL ALCOHOLMedline Industries, LPb43c0bff-82f8-c18d-e053-2995a90a87162025-10-16WarningsExact identifier
unii: ND2M416302
DentiCalmTOPICAL ANALGESICNFUSE LLC414e6f6f-06bb-b470-e063-6294a90af3902025-10-16WarningsExact identifier
unii: L7T10EIP3A
RBUGR QUIT SMOKING Nicotine PatchesNICOTINENanjing Ludejin Corporation Management Co., Ltd412d42c7-d382-20cc-e063-6294a90ae3842025-10-15WarningsExact identifier
unii: L7T10EIP3A
PERFORM LEO EXTENSIVE PAIN RELIEFLIDOCAINE, MENTHOLPERFORM LEO LLCf993ed5f-7dbb-4e3e-addf-f65b12f5cc482025-10-15WarningsExact identifier
unii: L7T10EIP3A
SEDLAVISOPROPYL ALCOHOLInstock Distributing1b31e3dc-31f3-dffe-e063-6394a90a1c962025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOLInstock Distributing1c470960-f78d-19e7-e063-6294a90a49202025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOLInstock Distributing1c477028-5cee-b8e2-e063-6394a90afb772025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOLInstock Distributing1c472c35-e241-773f-e063-6294a90abb572025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOL WIPESInstock Distributing1c478594-3118-048f-e063-6394a90a35d92025-10-15WarningsExact identifier
unii: ND2M416302
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICAATOSAFE CO., Ltd41196c2f-8e2e-a54d-e063-6294a90ad8a72025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICADONG IL PHARMS CO.,LTD41198822-7c8f-ceb2-e063-6394a90a43732025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD41197bb6-f6f4-c86d-e063-6294a90ad4762025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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