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 27 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPARTANLIDOCAINETIV PRIME SRL4e04146a-ed19-2271-e063-6394a90a50f02026-03-27WarningsExact identifier
application number: M017
Walgreens Pain Relieving LidocaineLIDOCAINEWalgreen Co.41d5bdc4-66c8-31ab-e063-6394a90a11952026-03-27WarningsExact identifier
application number: M017
Walgreens Cool N Heat PatchLIDOCAINE, MENTHOLWalgreen Co.41d64a88-90fc-27ca-e063-6294a90a602b2026-03-27WarningsExact identifier
application number: M017
Softlips Naturals MedicatedCAMPHOR, MENTHOLThe Mentholatum Company4e05d134-6c7f-1501-e063-6294a90ad27d2026-03-27WarningsExact identifier
application number: M017
Walgreens Cool N Heat Patch XLMENTHOLWalgreen Co.41e92435-7f77-a593-e063-6394a90a4b382026-03-27WarningsExact identifier
application number: M017
Walgreens Cool N Heat Back PatchMENTHOLWalgreen Co.41e81110-4b79-1fa6-e063-6394a90ae90c2026-03-27WarningsExact identifier
application number: M017
Softlips Naturals Medicated Elderberry AcaiCAMPHOR, MENTHOLThe Mentholatum Company4e0743a6-d450-043b-e063-6394a90ad1c22026-03-27WarningsExact identifier
application number: M017
QFSN Pain Relief CreamPAIN RELIEF CREAMQiaofusheng Pharmaceuticals Co., Ltd.4d215da1-87f5-d35d-e063-6394a90ac3482026-03-27WarningsExact identifier
application number: M017
FlexSport Roll OnMETHYL SALICYLATEPharmadel LLCbf8de3da-7628-6112-e053-2995a90a8e162026-03-26WarningsExact identifier
application number: M017
Kofal OriginalMETHYL SALICYLATEPharmadel LLC984780fd-496b-150b-e053-2995a90aed772026-03-26WarningsExact identifier
application number: M017
Kofal FuerteMETHYL SALICYLATEPharmadel LLC98488a07-eba0-2b4e-e053-2995a90ad6ab2026-03-26WarningsExact identifier
application number: M017
Kofal Max PowerMENTHOLPharmadel LLCfe1f1408-b0cb-67a4-e053-6394a90ad6092026-03-26WarningsExact identifier
application number: M017
KofalMETHYL SALICYLATEPharmadel LLC9cac377d-97bc-f0b7-e053-2a95a90a2e122026-03-26WarningsExact identifier
application number: M017
MilagrosoCAMPHORPharmadel LLC12b0401c-84d5-07cd-e063-6394a90a052c2026-03-26WarningsExact identifier
application number: M017
UbredolMETHYL SALICYLATEPharmadel LLCfe96eead-1722-c05d-e053-6394a90a850f2026-03-26WarningsExact identifier
application number: M017
DZUL PAIN FREEZE INSTANT PAIN RELIEFMENTHOLCaball Sales, Inc.4df3abcc-17f3-17f2-e063-6294a90afcca2026-03-26WarningsExact identifier
application number: M017
Equate Cool and Heat Extra StrengthMENTHOLWal-Mart Stores Incca3088a7-e1ec-4e69-80d9-fd0051bde9382026-03-25WarningsExact identifier
application number: M017
Ultra Strength Muscle Rub - CVS Health Ultra Strength Muscle RubCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy2ea95529-ec4b-c2ce-e063-6394a90a07392026-03-25WarningsExact identifier
application number: M017
NUMBING CREAMSMENTHOL LIDOCAINEYongchun Lihui Trading Co., Ltd.4dd38cdf-d644-6da0-e063-6294a90afb3d2026-03-25WarningsExact identifier
application number: M017
ANTIPHLAMINEL-MENTHOL, L-CAMPHOR, METHYL SALICYLATEMasaem Company4dd3ab12-6cd3-1060-e063-6394a90a2dec2026-03-25WarningsExact 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