FDA.reportPublic FDA data

Eagle Brand

Product NDC
60954-201
11-digit product format
609540201
Labeler code
60954
Product ID
60954-201_5cad19bd-b2a0-1e00-e063-6294a90ac213
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, menthol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
PT. EAGLE INDO PHARMA
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-04
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
4; 15.5 g/100g; g/100g
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
Eagle Brand
Brand name suffix
Eagle Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)4 g/100g
MENTHOL15.5 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-201-20Eagle BrandEagle Balm1 in 1 BOXOINTMENT15
60954-201-20Eagle BrandEagle Balm20 g in 1 JAROINTMENT205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-201EAGLE BRAND EAGLE BALM (CAMPHOR, MENTHOL) OINTMENT [PT. EAGLE INDO PHARMA]2Current NDC, 2 package rows20240113_0ba74dba-ec98-09d7-e063-6394a90a22db.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 131 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Poison Ivy WashPRAMOXINE HYDROCHLORIDE LOTIONCardinal Health, 110 dba Leader81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c2024-05-13WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited0e808f89-62dc-3790-e063-6394a90a23512024-05-13WarningsExact identifier
application number: M017
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Pain Relieving Cold GelCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1794c512-5f42-4ec3-e063-6394a90a87cd2024-05-03WarningsExact identifier
application number: M017
Professional Therapy MuscleCare ProMENTHOL AND CAMPHORACTIVE AND INNOVATIVE, LLC17961a84-6bee-c75f-e063-6394a90af5762024-05-03WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Pain Relieving CremeLIDOCAINE HYDROCHLORIDEChattem, Inc.d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd2024-05-01WarningsExact identifier
application number: M017
Lidocaine HCl 4 PercentLIDOCAINE HYDROCHLORIDEARI BRANDS, LLC81aff5c5-91c0-4173-a432-d201156135802024-04-30WarningsExact identifier
application number: M017
HealthWise 3x Medicated Pain Relief Patch 120 BulkCAMPHOR,MENTHOL, METHYL SALICYLATEVeridian Healthcare17545078-05e1-9338-e063-6394a90a678c2024-04-30WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Roll-onCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1755ec89-c404-1c17-e063-6394a90ab9fb2024-04-30WarningsExact identifier
application number: M017
PAIN RELIEF Gel-Roll OnMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bc2a14-6bda-428c-e053-2995a90a4ced2024-04-29WarningsExact identifier
application number: M017
PAIN RELIEF Gel-TubeMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bec1d4-2e18-4519-e053-2a95a90a1bbb2024-04-29WarningsExact identifier
application number: M017
THERAPLEX AIM Anti-Itch MoisturizingHYDROCORTISONETHERAPLEX, LLCd1b231b6-cc9f-488a-9121-5018314737722024-04-27WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE ACETATEJHK Inc dba American Safety & First Aid64adc8d0-7ca4-4c1a-813f-f1df47e916f22024-04-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
application number: M017
Hydrocortisone Cream with AloeHYDROCORTISONECardinal Health 110 dba LEADER16f2f3cb-4611-5867-e063-6394a90af1072024-04-25WarningsExact identifier
application number: M017
BurnLIDOCAINE HYDROCHLORIDEJHK Inc5a4ac4cc-015a-48e7-81f8-93a895049afd2024-04-25WarningsExact identifier
application number: M017
Cold Therapy Pain ReliefMENTHOL, UNSPECIFIED FORMWalgreen Co.ede15818-5d17-477d-a8be-7b36bb0770a62024-04-22WarningsExact identifier
application number: M017
Anti ItchHYDROCORTISONENeilmed Pharmaceuticals Inc.14b4f066-fde4-ac97-e063-6394a90ae64c2024-04-20WarningsExact identifier
application number: M017
Walgreens Cold Therapy Pain Relief PatchMENTHOL 5%Walgreens Companye33c90d1-2729-970f-e053-2995a90ad97a2024-04-18WarningsExact identifier
application number: M017
HealthWise Cold Therapy Pain Relief PatchMENTHOLVeridian Healthcare0ce356e0-90a3-ad52-e063-6294a90a404a2024-04-18WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2672957camphor 4 % / menthol 15.5 % Topical OintmentPSN0ba74dba-ec98-09d7-e063-6394a90a22db5
2672957camphor 0.04 MG/MG / menthol 0.155 MG/MG Topical OintmentSCD0ba74dba-ec98-09d7-e063-6394a90a22db5
2672957camphor 4 % / menthol 15.5 % Topical OintmentSY0ba74dba-ec98-09d7-e063-6394a90a22db5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60954-201-20609540201201 JAR in 1 BOX (60954-201-20) / 20 g in 1 JAR1 jar2023-12-04NoNoCurrent