FDA.reportPublic FDA data

BioFreeze Dry Stick

Product NDC
59316-230
11-digit product format
593160230
Labeler code
59316
Product ID
59316-230_51b58d0f-b967-1b22-e063-6294a90ac892
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
STICK
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-28
Substance
MENTHOL
Active strength
.15 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
BioFreeze Dry Stick
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.15 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26d62cd2-9209-8cca-e063-6394a90a2028Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-230-23BioFreeze Dry Stick22 g in 1 TUBESTICK222
59316-230-23BioFreeze Dry Stick1 in 1 CARTONSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-230BIOFREEZE DRY STICK (MENTHOL) STICK [RB HEALTH (US) LLC]1Current NDC, 2 package rows20241228_26d62cd2-9209-8cca-e063-6394a90a2028.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 43 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEHY-VEE, INC48350b54-8d9a-48c4-e063-6394a90ac0402026-01-12WarningsExact identifier
application number: M017
LidoPlus Pain ReliefLIDOCAINE HYDROCHLORIDECentura Pharmaceuticals, Inc07bacc6c-60a6-4297-8663-904a22bdc0402026-01-12WarningsExact identifier
application number: M017
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf1efb51c-5217-4cb2-e053-2a95a90a7f952026-01-12WarningsExact identifier
application number: M017
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf2277e27-868b-57ef-e053-2a95a90abf282026-01-12WarningsExact identifier
application number: M017
BLT 3TETRACAINECENTURA PHARMACEUTICALS INC401a0d22-1181-02ac-e054-00144ff88e882026-01-12WarningsExact identifier
application number: M017
Sting Relief Prep PadBENZOCAINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.0c901f64-6890-45c0-9ca7-ee9de87903c42026-01-12WarningsExact identifier
application number: M017
Goodsense Oral Pain ReliefBENZOCAINEGeiss, Destin and Dunn, Inc.eb461b70-d10f-4e11-8374-e43713f3504d2026-01-12WarningsExact identifier
application number: M017
Extra Strength BalmCAPSICUM AND MENTHOLSaje Natural Business Incf516e416-446b-8f21-e053-2a95a90afd882026-01-12WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.3df0e56a-7651-42dc-8ed8-f68836a63c612026-01-12WarningsExact identifier
application number: M017
Trauma LessMENTHOLSaje Natural Business Inc.650cba4c-6aba-48c3-9c41-841f199055482026-01-12WarningsExact identifier
application number: M017
MamisanLIDOCAINE HYDROCHLORIDE, MENTHOLMiramar Cosmetics, Inc DBA Miramar Lab4402e900-c6e9-4f32-8cc4-c84014384a9f2026-01-12WarningsExact identifier
application number: M017
Curist Lidocaine PatchLIDOCAINE 4% PATCHLittle Pharma, Inc.1a8fe44e-7a21-c2ab-e063-6394a90a61002026-01-11WarningsExact identifier
application number: M017
DG Health Pain RelievingLIDOCAINE HCLDOLGENCORP, LLC923aeb4c-049f-4ecc-a77e-9ffa0e236d4e2026-01-11WarningsExact identifier
application number: M017
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare46b84e0b-78a9-4cde-9f90-e165b54191622026-01-09WarningsExact identifier
application number: M017
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-OnMENTHOLInspec Solutions12ff9b9a-73e5-ce31-e063-6294a90aeaf82026-01-09WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bb0278c9-eaff-d435-e053-2995a90a202a2026-01-09WarningsExact identifier
application number: M017
Lidocaine HCILIDOCAINE HCITrifluent Pharma, LLC47f7f06b-720e-eeec-e063-6294a90ae8232026-01-09WarningsExact identifier
application number: M017
LidocaineLIDOCAINEBellus Medical, LLC60cb89f6-e326-0773-e053-2a91aa0a33dd2026-01-09WarningsExact identifier
application number: M017
TetracaineTETRACAINEBellus Medical, LLC60cabb5f-606b-7a74-e053-2a91aa0ac0242026-01-09WarningsExact identifier
application number: M017
BenzocaineBENZOCAINEBellus Medical, LLC60cafbaf-8ec6-46a5-e053-2a91aa0af11f2026-01-09WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59316-230-23593160230231 TUBE in 1 CARTON (59316-230-23) / 22 g in 1 TUBE1 tube2024-12-28NoNoCurrent