FDA.reportPublic FDA data

Tiger Balm

Manufacturer
Haw Par Healthcare Ltd. | Xiamen Tiger Medical Company, Ltd | Tiger Balm (Malaysia) Sdn. Bhd. | Identipak
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
27
Source
full-release
Hydrated at
2026-06-01 01:27:01

Label at a glance#

ProductTiger Balm Ultra Strength
Active ingredientCamphor (Synthetic), Menthol, Unspecified Form
Label structure10 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, bruises, strains, sprains and arthritis.

Dosage and administration

For adults and children over 12, rub well on the affected area. Repeat 3 to 4 times daily For children 12 years of age or younger, consult a doctor before use.

Storage and handling

This product may cause allergic reaction on some individuals. Test on small area before use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Camphor 11%Topical Analgesic
Menthol 11%Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, bruises, strains, sprains and arthritis.

Warnings

WARNINGS SECTION

For External Use Only

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with wrap or use heating pad
  • Do not use 1 hour prior to bathing or within 30 minutes after bathing.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than 7 days
  • Pain clears up and then recurs a few days later.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For adults and children over 12, rub well on the affected area. Repeat 3 to 4 times daily
  • For children 12 years of age or younger, consult a doctor before use.

Other information

STORAGE AND HANDLING SECTION

This product may cause allergic reaction on some individuals. Test on small area before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cajuput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil and Paraffin Petrolatum.

SPL UNCLASSIFIED SECTION

Manufactured by Haw Par Healthcare Ltd., Singapore under license from Haw Par Corporation Ltd.

Questions

OTC - QUESTIONS SECTION

(510) 887-1899

PRINCIPAL DISPLAY PANEL - 10 G Jar Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 66761-315-35

TIGER BALM®
Ultra STRENGTH

NON-STAINING - CONCENTRATED
PAIN RELIEVING OINTMENT
WORKS WHERE IT HURTS®

FOR MUSCLE
ACHES AND
PAINS

Ultra
STRENGTH

NET WT. 0.35 OZ. (10G)

PRINCIPAL DISPLAY PANEL - 10 G Jar Box
PRINCIPAL DISPLAY PANEL - 10 G Jar Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1089847camphor 11 % / menthol 11 % Topical OintmentPSN27
1089847camphor 0.11 MG/MG / menthol 0.11 MG/MG Topical OintmentSCD27
1089847camphor 11 % / menthol 11 % Topical OintmentSY27

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66761-315-02Tiger Balm Ultra Strength2 g in 1 POUCHOINTMENT227
66761-315-07Tiger Balm Ultra Strength2 g in 1 POUCHOINTMENT227
66761-315-08Tiger Balm Ultra Strength8 g in 1 JAROINTMENT827
66761-315-08Tiger Balm Ultra Strength1 in 1 BOXOINTMENT127
66761-315-10Tiger Balm Ultra Strength1 in 1 BOXOINTMENT127
66761-315-10Tiger Balm Ultra Strength18 g in 1 JAROINTMENT1827
66761-315-35Tiger Balm Ultra Strength1 in 1 BOXOINTMENT127
66761-315-35Tiger Balm Ultra Strength10 g in 1 JAROINTMENT1027
66761-315-50Tiger Balm Ultra Strength1 in 1 BOXOINTMENT127
66761-315-50Tiger Balm Ultra Strength50 g in 1 JAROINTMENT5027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66761-315-08GM - Gram66761-315fd6d7dea-97f3-436b-a2fd-7453fbd93c0012024-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Camphor (Synthetic)ACTIVE INGREDIENT5TJD82A1ET4
MentholACTIVE INGREDIENTL7T10EIP3A4
Camphor (Synthetic)ACTIVE MOIETY5TJD82A1ET4
MentholACTIVE MOIETYL7T10EIP3A4
Cajuput oilINACTIVE INGREDIENTJ3TO6BUQ374
Chinese Cinnamon OilINACTIVE INGREDIENTA4WO0626T54
Clove oilINACTIVE INGREDIENT578389D6D04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66761-31566761-315-08, 66761-315-02, 66761-315-07, 66761-315-10, 66761-315-50, 66761-315-35

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
Camphor (Synthetic)5TJD82A1ETACTIB
Menthol, Unspecified FormL7T10EIP3AACTIB
Cajuput oilJ3TO6BUQ37IACT
Chinese Cinnamon OilA4WO0626T5IACT
Clove oil578389D6D0IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Clove oilCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
21 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tiger Balm Ultra StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.f0561804-e0f7-495d-9768-9b86a208c51e2025-12-17WarningsExact identifier
ndc (package): 66761-315-50
ndc (package): 66761-315-07
ndc (package): 66761-315-08
ndc (package): 66761-315-10
ndc (package): 66761-315-35
ndc (package): 66761-315-02
ndc (product): 66761-315
ndc11 (package): 66761031550
ndc11 (package): 66761031510
ndc11 (package): 66761031535
ndc11 (package): 66761031507
ndc11 (package): 66761031508
ndc11 (package): 66761031502
spl id: 6e727082-0efe-4ab6-9ba0-a4e59c989e71
spl set id: f0561804-e0f7-495d-9768-9b86a208c51e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.