FDA.reportPublic FDA data

Tiger Balm

Product NDC
66761-322
11-digit product format
667610322
Labeler code
66761
Product ID
66761-322_d034f794-5294-4cb9-8fab-487ac4bf640f
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor (Synthetic), Menthol, and Capsicum
Dosage form
PATCH
Route
TOPICAL
Labeler
Haw Par Healthcare Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-11-15
Substance
CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; CAPSICUM
Active strength
80; 24; 16 mg/1; mg/1; mg/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]
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
Tiger Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)80 mg/1
MENTHOL, UNSPECIFIED FORM24 mg/1
CAPSICUM16 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
00UK7646FGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
853132Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5066dc10-e4d5-49e9-9a5f-0ac220cfbf28Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66761-322-01Tiger Balm36 in 1 BOXPATCH3612
66761-322-01Tiger Balm1 in 1 PACKETPATCH112
66761-322-02Tiger Balm36 in 1 BOXPATCH3612
66761-322-02Tiger Balm1 in 1 PACKETPATCH112
66761-322-05Tiger Balm1 in 1 BOXPATCH112
66761-322-05Tiger Balm5 in 1 PACKETPATCH512
66761-322-12Tiger Balm1 in 1 PACKETPATCH112
66761-322-12Tiger Balm12 in 1 BOXPATCH1212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66761-322-05EA - Each66761-3229effe184-8754-4ed2-95fa-df236d6c3e9d12023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Camphor (Synthetic)ACTIVE INGREDIENT5TJD82A1ETTIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
CapsicumACTIVE INGREDIENT00UK7646FGTIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
MentholACTIVE INGREDIENTL7T10EIP3ATIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
Camphor (Synthetic)ACTIVE MOIETY5TJD82A1ETTIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
CapsicumACTIVE MOIETY00UK7646FGTIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
MentholACTIVE MOIETYL7T10EIP3ATIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS311TIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
Eucalyptus OilINACTIVE INGREDIENT2R04ONI662TIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
GlycerinINACTIVE INGREDIENTPDC6A3C0OXTIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
HydrotalciteINACTIVE INGREDIENT17432CG1KUTIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
KaolinINACTIVE INGREDIENT24H4NWX5COTIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3TIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
SorbitolINACTIVE INGREDIENT506T60A25RTIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4
WaterINACTIVE INGREDIENT059QF0KO0RTIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66761-322TIGER BALM (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM) PATCH [HAW PAR HEALTHCARE LTD.]11Current NDC, Legacy NDC, 8 package rows20240622_5066dc10-e4d5-49e9-9a5f-0ac220cfbf28.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 19 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC3f2b1f48-2d78-4985-a046-9f72de5e1a9b2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC10a8face-47da-ebbe-e063-6294a90a42fe2026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot CreamMENTHOLReckitt Benckiser LLC32450cbf-4ed4-402b-a30e-e08a17bba3fb2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLCa227213b-e89f-7144-e053-2a95a90a7e742026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC00bb462a-27d0-6f74-e063-6394a90a90ec2026-05-13WarningsExact identifier
application number: M017
BioFreeze Dry StickMENTHOLReckitt Benckiser LLC26d62cd2-9209-8cca-e063-6394a90a20282026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot Pain Relief SetMENTHOLReckitt Benckiser LLC4a885eef-0364-4655-bccc-7158c76cc5b22026-05-13WarningsExact identifier
application number: M017
Biofreeze Colorless Roll-OnMENTHOLReckitt Benckiser LLCa8d59d45-0e85-43d1-affd-bbe922c4acb12026-05-13WarningsExact identifier
application number: M017
Biofreeze ColorlessMENTHOLReckitt Benckiser LLC939dbbc3-71ec-4990-840e-7c9b8d4305622026-05-13WarningsExact identifier
application number: M017
Biofreeze Flexible Relief StripMENTHOLReckitt Benckiser LLC6ec26bae-e395-49aa-969e-8c653d6f0b272026-05-13WarningsExact identifier
application number: M017
Biofreeze Day and OvernightMENTHOLReckitt Benckiser LLCfb5c8f89-a720-ad32-e053-6294a90a2abe2026-05-13WarningsExact identifier
application number: M017
Biofreeze FoamMENTHOLReckitt Benckiser LLC890191e8-99ad-489c-8f21-2592f3d319362026-05-13WarningsExact identifier
application number: M017
Orajel Cold Sore Touch Free - Single DoseBENZALKONIUM CHLORIDE, BENZOCAINEChurch & Dwight Co., Inc.ce40829e-941f-2548-e053-2995a90a1e0e2026-05-13WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP51b7753b-8619-6ea9-e063-6294a90a4ea42026-05-13WarningsExact identifier
application number: M017
DERMFREE Anti-itch CreamHYDROCORTISONE1% ANTI-ITCH CREAMJiangxi Zhongletang Pharmaceuticals Co.,Ltd.519c319a-9c43-0e63-e063-6394a90ab8692026-05-13WarningsExact identifier
application number: M017
Valtrum TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELaboratorios Quantium LLCf3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e2026-05-13WarningsExact identifier
application number: M017
Biofreeze Professional ColorlessMENTHOL, UNSPECIFIED FORMReckitt Benckiser4639201c-a67a-475f-8df6-3dc6225803ad2026-05-12WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCbae9946a-4c68-4759-9fb3-0a61a7ad0eb72026-05-12WarningsExact identifier
application number: M017
Instaflex Pain Relief CreamMENTHOLHealthy Directions, LLC665b847a-9cfb-49fc-975b-81c97f9365752026-05-12WarningsExact identifier
application number: M017
Theracare Cold Therapy Pain ReliefMENTHOLVeridian Healthcare51a5a043-07b6-1c96-e063-6394a90aa9262026-05-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
853132camphor 80 MG / capsicum 16 MG / menthol 24 MG Medicated PatchPSN5066dc10-e4d5-49e9-9a5f-0ac220cfbf2812
853132camphor 80 MG / Capsicum extract 16 MG / menthol 24 MG Medicated PatchSCD5066dc10-e4d5-49e9-9a5f-0ac220cfbf2812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66761-322-016676103220136 PACKET in 1 BOX (66761-322-01) / 1 PATCH in 1 PACKET36 packet2001-11-150000-00-00NoNoCurrent
66761-322-026676103220236 PACKET in 1 BOX (66761-322-02) / 1 PATCH in 1 PACKET36 packet2001-11-150000-00-00NoNoCurrent
66761-322-05667610322051 PACKET in 1 BOX (66761-322-05) / 5 PATCH in 1 PACKET1 packet2001-11-150000-00-00NoNoCurrent
66761-322-126676103221212 PACKET in 1 BOX (66761-322-12) / 1 PATCH in 1 PACKET12 packet2016-12-010000-00-00NoNoCurrent