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 116 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care MentholMENTHOL 4%Safeway27d3cb47-a6c7-5b7a-e063-6394a90a056f2024-12-05WarningsExact identifier
application number: M017
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
application number: M017
PO First Aid Series BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.f1c349a8-216d-4233-922e-c95329a33d1e2024-12-05WarningsExact identifier
application number: M017
Post Treatment BalmHYDROCORTISONEAllure Labs Inc.faa803e6-453c-4d86-85dd-5a5dcdd72d022024-12-05WarningsExact identifier
application number: M017
CBD Pain Relief CreamTROLAMINE SALICYLATEAllure Labsb6b3102a-4154-2da2-e053-2995a90ae99f2024-12-05WarningsExact identifier
application number: M017
CVS Health Pain RelievingCAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATENatural Essentials, Inc.f7198485-3d68-41d2-b9b9-f932a06493102024-12-04WarningsExact identifier
application number: M017
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
application number: M017
Bite and ItchDIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEWeeks & Leo Co., Inc.0a4d471b-c3f3-0a6a-e063-6394a90ad57b2024-12-03WarningsExact identifier
application number: M017
MentholAMISH ORIGINS MEDICATEDAmish Origins LLC547abe39-3af3-4d70-99dd-caf8d67feda22024-12-03WarningsExact identifier
application number: M017
Meijer Small Cold-Hot Medicated PatchesMENTHOLMeijer Distribution Incbe6012d6-2062-45ba-8fc4-abf14cff58452024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.acdd5622-a9a7-4cc3-877e-57efea23303f2024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff52024-12-03WarningsExact identifier
application number: M017
Salonpas DEEP RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu America, Inc.a4ddb2b9-d023-4c8c-9285-93d51f93207d2024-12-03WarningsExact identifier
application number: M017
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief - OvernightLIDOCAINETelebrands Corp1030d478-6805-6579-e063-6294a90a0c762024-12-02WarningsExact identifier
application number: M017
Campho-Phenique Cold Sore TreatmentCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC106c0bb2-f2e2-4255-867d-d09ff6a5a2e62024-12-02WarningsExact identifier
application number: M017
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC82edaef0-0709-4ae1-a664-c9c5adb91ee12024-12-02WarningsExact identifier
application number: M017
Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll OnTHERMACARE CAPSAICIN ROLL ONClarion Brands LLC2850f7e7-41dd-f5f9-e063-6394a90ae5192024-12-02WarningsExact identifier
application number: M017
BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENINGBO TIANBO FIRST AID PRODUCT CO., LTD.2ec1cf79-c341-4b79-9047-ce29f0dff4192024-11-29WarningsExact identifier
application number: M017
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare242204d3-efc7-f7a9-e063-6294a90a5af12024-11-27WarningsExact 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