FDA.reportPublic FDA data

BIO-ICE

Product NDC
50130-316
11-digit product format
501300316
Labeler code
50130
Product ID
50130-316_463d9205-8ccc-8c5c-e063-6394a90a47c5
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, CAMPHOR
Dosage form
GEL
Route
TOPICAL
Labeler
Electrostim Medical Services Inc. d/b/a EMSI
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-01
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
5.4; .48 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50130-316-11fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50130-316-1186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50130-316-11bd6a592717d7…303034d00443…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50130-316-11e2bbac7714bc…27bdfed8d636…

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
BIO-ICE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.4 g/100mL
CAMPHOR (SYNTHETIC).48 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
5TJD82A1ETInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1372902Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1bfd1468-9139-43b1-9709-d47b63d17cfbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-10-20BIO-ICE
2022-01-28BIO-ICE
2020-12-31BIO-ICE
2020-09-27BIO-ICE
2020-09-25BIO-ICE
2020-07-22BIO-ICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50130-316-11BIO-ICE88.8 mL in 1 BOTTLEGEL88.88

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETBIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ABIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETBIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
MENTHOLACTIVE MOIETYL7T10EIP3ABIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626QBIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
BOSWELLIA SERRATA RESIN OILINACTIVE INGREDIENT5T1XCE6K8KBIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
CAMPHOR OILINACTIVE INGREDIENT75IZZ8Y727BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27EBIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FBIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
UNCARIA TOMENTOSA LEAFINACTIVE INGREDIENT487U8M3D2PBIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1
WATERINACTIVE INGREDIENT059QF0KO0RBIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50130-316BIO-ICE (MENTHOL, CAMPHOR) GEL [ELECTROSTIM MEDICAL SERVICES INC. D/B/A EMSI]7Current NDC, Legacy NDC, 1 package rows20241213_1bfd1468-9139-43b1-9709-d47b63d17cfb.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 45 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
application number: M017
TOPICAINELIDOCAINE 4%ESBA LABORATORIES INC.7f96e980-891e-743d-e053-2a91aa0aea5f2026-01-08WarningsExact identifier
application number: M017
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
application number: M017
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLUniversal Distribution Center LLC66892993-a755-4584-b2a8-2e8d7ac705932026-01-08WarningsExact identifier
application number: M017
Private Label Antifungal Barrier Cream2% MICONAZOLE NITRATE CREAMSwiss-American CDMO, LLCe74bddea-c1ac-4e4e-84bd-5a9defb85b2d2026-01-08WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLCe1911279-85f7-4053-b6da-8f4e991347a22026-01-08WarningsExact identifier
application number: M017
POMG PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDE, MENTHOLPOMG LLC1fa980fb-fc0e-fdd0-e063-6394a90adc132026-01-07WarningsExact identifier
application number: M017
Artridon GlucosamineMENTHOL, METHYL SALICYLATEPharmadel LLC73572156-4cce-0669-e053-2991aa0aaecc2026-01-07WarningsExact identifier
application number: M017
HealthWise Cooling Pain ReliefMENTHOLVeridian Healthcare6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd2026-01-07WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-Itch CreamHYDROCORTISONEDLC Laboratories, Inc.16eeec2c-065d-4da0-e063-6294a90a38732026-01-07WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONEDLC Laboratories, Inccaf50f12-f35c-4e9e-8ef7-3b0c84e225ee2026-01-07WarningsExact identifier
application number: M017
EARTHS CARE MUSCLE AND JOINT RUBCAMPHORDLC Laboratories, Inc.71e33e06-4dc3-4ead-a122-ff89d93a64de2026-01-07WarningsExact identifier
application number: M017
Amour CBDPAIN RELIEF CREAMSVD Premium Products95b45e79-b1e7-17b2-e053-2995a90a88362026-01-07WarningsExact identifier
application number: M017
Tiger Balm Active MuscleMETHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.845a4ead-f9c0-4009-bcae-b17cd388439b2026-01-07WarningsExact identifier
application number: M017
3X Medicated Toothache and Gum GelBENZOCAINERite Aid996f7989-17ce-5b28-e053-2995a90af8b82026-01-06WarningsExact identifier
application number: M017
QNTAMAX Muscle and Joint Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLQntamax LLC6622b94c-824e-4e84-a8d8-b60bb0b866e22026-01-06WarningsExact identifier
application number: M017
Winco Muscle and Joint Pain Relief Gel 2ozWINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEFWINCO FOODS, LLC47bedf4e-4036-cf43-e063-6394a90a91d62026-01-06WarningsExact identifier
application number: M017
Pain Relief Hot PatchMENTHOL AND CAPSAICINUniversal Distribution Center LLC110bcb16-ef0b-4bc8-8877-173a0494e1ad2026-01-06WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4582b4e9-0c24-069d-e063-6394a90a6f4b2026-01-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372902camphor 0.48 % / menthol 5.4 % Topical GelPSN1bfd1468-9139-43b1-9709-d47b63d17cfb8
1372902camphor 0.0048 MG/MG / menthol 0.054 MG/MG Topical GelSCD1bfd1468-9139-43b1-9709-d47b63d17cfb8
1372902camphor 0.48 % / menthol 5.4 % Topical GelSY1bfd1468-9139-43b1-9709-d47b63d17cfb8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50130-316-115013003161188.8 mL in 1 BOTTLE (50130-316-11) 88.8 ml2013-01-010000-00-00NoNoCurrent