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 10 of 207 · 4,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADVOCATE Sterile Alcohol Prep PadsISOPROPYL ALCOHOLPHARMA SUPPLY, INCa87dd40d-a9b1-4bb5-acc2-2d00abc2034a2026-07-30WarningsExact identifier
unii: ND2M416302
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
ACOLYE Lidocaine Cream Topical Analgesia CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd57deebf7-52f1-4256-e063-6294a90a75d52026-07-30WarningsExact identifier
unii: L7T10EIP3A
Icy Hot Performance No-Mess Pain Relief CreamMENTHOL 16%, CAMPHOR 11%Chattem, Inc.5e3e272a-c001-4f57-9535-521ccc85ae652026-07-30WarningsExact identifier
unii: L7T10EIP3A
Maximun Strength Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLMeijer Distribution Incd0468514-58ea-4d8f-b634-a65bf95c03162026-07-29WarningsExact identifier
unii: L7T10EIP3A
Rugby Muscle Rub CreamMUSCLE RUB CREAMPreferred Pharmaceuticals Inc.ea209a4e-acad-413b-8fb9-27e98130bcd62026-07-28WarningsExact identifier
unii: L7T10EIP3A
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
70% Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions57ac6fef-21de-e214-e063-6394a90a6c9e2026-07-28WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions LLC57acc1ff-2564-1e61-e063-6394a90a3c912026-07-28WarningsExact identifier
unii: ND2M416302
LidoProLIDOCAINE AND MENTHOLClinic Pharmacdfd6b39-b430-4e95-a0f7-682cf3d78b522026-07-28WarningsExact identifier
unii: L7T10EIP3A
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHClinic Pharma2b4d2105-b7ad-2695-e063-6394a90a999b2026-07-28WarningsExact identifier
unii: L7T10EIP3A
HEMPE Ice Muscle and Joint GelMENTHOLHealthcare International Research Limited57aec922-1de4-c579-e063-6394a90af6c82026-07-28WarningsExact identifier
unii: L7T10EIP3A
Green bud SOOTHING MASSAGE FLUIDGREEN BUD SOOTHING MASSAGE FLUIDWANWANG INC57b01b7b-0ea9-f8c9-e063-6394a90a95c62026-07-28WarningsExact identifier
unii: L7T10EIP3A
Earths Care Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEDLC Laboratories, Inc.5c3976da-a6cb-4b94-ae41-3e86b1ab13cb2026-07-28WarningsExact identifier
unii: L7T10EIP3A
unii: N20HL7Q941
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Preferred Pharmaceuticals Inc.9e7568b6-52ae-4f7a-9bfd-503fd80a297e2026-07-28WarningsExact identifier
unii: L7T10EIP3A
KENS PAIN AND ARTHRITIS FORMULAMENTHOLEezaway Relief Inc35834473-3ad5-41ec-a110-e742aa7e2ee42026-07-28WarningsExact identifier
unii: L7T10EIP3A
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC57984bc2-bf1d-c423-e063-6394a90a06ae2026-07-27WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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