FDA.reportPublic FDA data

BT Pain Relief Balm

Product NDC
82198-0010
Requested package NDC
82198-0010-1
11-digit product format
821980010
Labeler code
82198
Product ID
82198-0010_0aa441d8-a293-a678-e063-6294a90a698e
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate, Menthol, Camphor
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Big 5 Nutrition LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAMPHOR, (-)-
Active strength
207.3; 155.5; 31.1 mg/g; mg/g; mg/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
BT Pain Relief Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE207.3 mg/g
MENTHOL, UNSPECIFIED FORM155.5 mg/g
CAMPHOR, (-)-31.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup
213N3S8275Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1990875Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
50112419-c934-4d3a-9ea6-9b089f516a6dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82198-0010-1BT Pain Relief Balm35 g in 1 JAROINTMENT351
82198-0010-1BT Pain Relief Balm1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82198-0010BT PAIN RELIEF BALM (METHYL SALICYLATE, MENTHOL, CAMPHOR) OINTMENT [BIG 5 NUTRITION LLC]1Current NDC, 2 package rows20240101_50112419-c934-4d3a-9ea6-9b089f516a6d.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 103 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LABOFLEX Lidocaine Pain Relieving PatchLIDOCAINE 4%Laboflex, Inc.31995f31-c272-afdb-e063-6294a90af3f92025-01-10WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Chain Drug Marketing Association Inc.2b48cb2f-e6bf-f9de-e063-6394a90a42d42025-01-09WarningsExact identifier
application number: M017
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
application number: M017
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
application number: M017
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
application number: M017
Bactine MaxLIDOCAINEWellSpring Pharmaceutical Corporationacd7ae37-7c42-4ec7-a2ef-42e7f628388d2025-01-08WarningsExact identifier
application number: M017
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
application number: M017
Sinsin MulpasCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.22ea8a51-fdee-4650-abf8-f996268c93032025-01-07WarningsExact identifier
application number: M017
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
application number: M017
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact identifier
application number: M017
Lidocare Arm, Neck, Leg4% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC59a104ee-7034-99c3-e053-2991aa0a164c2025-01-06WarningsExact identifier
application number: M017
Salonpas LIDOCAINE Pain RelievingLIDOCAINEHisamitsu Pharmaceutical Co., Inc.4f3a438c-f378-4d2a-a95c-58e56cf1e7972025-01-06WarningsExact identifier
application number: M017
Lidocare 034% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC416ebf5a-2efb-6d0b-e054-00144ff88e882025-01-06WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll-onMENTHOLADP Health Limitede0bb77b2-45ee-45fa-9659-9c7d99bb20dc2025-01-05WarningsExact identifier
application number: M017
health and beyond BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b6bb3ed-50fb-40c4-acb6-ae3f160315312025-01-05WarningsExact identifier
application number: M017
glo SKIN BEAUTY Remedy GelGLO SKIN BEAUTY REMEDY GELHayden Caleel LLCaa47ff08-07b3-4fd1-bae5-420e4b928f062025-01-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1990875camphor 3.1 % / menthol 15.6 % / methyl salicylate 20.7 % Topical OintmentPSN50112419-c934-4d3a-9ea6-9b089f516a6d1
1990875camphor 0.031 MG/MG / menthol 0.156 MG/MG / methyl salicylate 0.207 MG/MG Topical OintmentSCD50112419-c934-4d3a-9ea6-9b089f516a6d1
1990875camphor 3.1 % / menthol 15.6 % / methyl salicylate 20.7 % Topical OintmentSY50112419-c934-4d3a-9ea6-9b089f516a6d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82198-0010-1821980010011 JAR in 1 BOX (82198-0010-1) / 35 g in 1 JAR1 jar2024-01-01NoNoCurrent