FDA.reportPublic FDA data

BT Pain Relief Balm

Product NDC
82198-0010
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
2026-12-31
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
2026-12-31

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 76 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLC66b13044-69d2-4559-9e65-8a4c601c077a2025-10-06WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLCf119a1bd-095f-41f5-86d5-c0ee4f19fd2c2025-10-06WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINEPHARMACURE LLC31d5e5c9-6ec4-4496-8a4c-cca39a2cbe322025-10-06WarningsExact identifier
application number: M017
Tempo coolMENTHOLThe Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.Ebd642389-6d03-4e09-a71c-312fb90eae892025-10-06WarningsExact identifier
application number: M017
Menthopatch HotMENTHOL , CAPSICUM EXTRACTTHE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID3d289be3-c237-4065-a8ac-e8c2e51b76a52025-10-06WarningsExact identifier
application number: M017
Mentho patch coolMENTHOLTHE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID02251a4a-fc6f-42c9-a244-6f4835de5edd2025-10-06WarningsExact identifier
application number: M017
Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)aa6cc963-dc60-5222-e053-2995a90acaf62025-10-06WarningsExact identifier
application number: M017
TheraCare 2% Diphenhydramine Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEVeridian Healthcare5999b677-63dd-49c6-b5b8-7b3c117ecc5c2025-10-06WarningsExact identifier
application number: M017
HealthWise Pain ReliefMENTHOLVeridian Healthcare06be5331-7a1e-4ab3-9f17-2d350bd4b8902025-10-02WarningsExact identifier
application number: M017
equate Burn ReliefLIDOCAINE HYDROCHLORIDEWalmart Inca90cbd92-80a5-4463-8152-b83165121a6f2025-10-02WarningsExact identifier
application number: M017
AsperFlex HOTCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.a6cb0656-8866-44ff-b40c-73655ff687212025-10-02WarningsExact identifier
application number: M017
AsperFlex Original Maximum StrengthMENTHOLAkron Pharma Inc.d766c61e-c48b-4aff-97b0-678159479e032025-10-02WarningsExact identifier
application number: M017
HealthWise Feminine Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare1f9110da-f448-8e20-e063-6294a90a42752025-10-02WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCdc704403-e2aa-47f7-a7f4-f6afe1547ca82025-10-01WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCe02558a9-fe2b-4f28-9fd3-7308f859d7592025-10-01WarningsExact identifier
application number: M017
FL Burn Ease, 0.9gLIDOCAINEProStat First Aid LLC4dc0d579-ab42-4ea5-9788-5e54d7d318a32025-10-01WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.c7a7626c-cf82-4301-af79-c5e85367e7772025-10-01WarningsExact identifier
application number: M017
Viaderma Calm Anti-ItchHYDROCORTISONEViaDerma Distribution, Inc.7afa2ccd-bfc6-48fc-9a14-a0c6d645844e2025-10-01WarningsExact identifier
application number: M017
AsperFlex AdvanceCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.d23d7f2b-4dcd-4c31-9d12-340f233018b42025-10-01WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INC4024d604-c8c7-2d73-e063-6294a90a2e802025-10-01WarningsExact 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