FDA.reportPublic FDA data

Eagle Brand

Product NDC
43405-017
11-digit product format
434050017
Labeler code
43405
Product ID
43405-017_2c2e4588-e839-9660-e063-6294a90af46e
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, menthol, methyl salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
Borden Company (Private) Limited
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-01
Substance
METHYL SALICYLATE; CAMPHOR (SYNTHETIC); MENTHOL
Active strength
35; 7; 16 g/100mL; g/100mL; g/100mL
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
Medicated Roll On Aromatic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE35 g/100mL
CAMPHOR (SYNTHETIC)7 g/100mL
MENTHOL16 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1654728Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1c3e5068-dd61-ebdb-e063-6294a90a97ccAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43405-017-08Eagle BrandMedicated Roll On Aromatic8 mL in 1 BOTTLE, GLASSOIL82
43405-017-08Eagle BrandMedicated Roll On Aromatic1 in 1 BOXOIL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-017EAGLE BRAND MEDICATED ROLL ON AROMATIC (CAMPHOR, MENTHOL, METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED]2Current NDC, 2 package rows20250122_1c3e5068-dd61-ebdb-e063-6294a90a97cc.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 126 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Anti ItchHYDROCORTISONEL. Perrigo Companyecd6d841-40b9-42c9-825d-d172cd04824d2024-10-03WarningsExact identifier
application number: M017
Gold Bond Medicated Original Strength BodyMENTHOLNavajo Manufacturing Company Inc.f71d598c-92c3-d6fd-e053-6394a90a97d72024-10-03WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafeway9e663535-4acc-4b37-acae-8c17517c5a3d2024-10-03WarningsExact identifier
application number: M017
Topcare HydrocortisoneHYDROCORTISONETopco Associates LLC849c60fc-e455-4c50-8adf-ac59c0ee785b2024-10-03WarningsExact identifier
application number: M017
rexall anti itch maximum strength reliefHYDROCORTISONEDolgencorp, LLC894cf9ab-693a-4210-96df-605947f51b632024-10-03WarningsExact identifier
application number: M017
equaline anti itch maximum strengthHYDROCORTISONEUnited Natural Foods, Inc. dba UNFI070000d7-7d4d-439b-9a91-851ba7c027e62024-10-03WarningsExact identifier
application number: M017
hydrocortisone anti itchHYDROCORTISONEH E Ba1a9fed8-4938-48b5-81f1-d3942d534bb82024-10-03WarningsExact identifier
application number: M017
equaline anti itchHYDROCORTISONEUnited Natural Foods, Inc. dba UNFIef9ea069-9b97-4bf5-aaac-deb85334dbd02024-10-03WarningsExact identifier
application number: M017
Basic Care HydrocortisoneHYDROCORTISONEAmazon.com Services LLC7fa13ab4-5f2d-4a48-816f-1b22d5f757b22024-10-03WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEA-S Medication Solutionsdc388dc1-0c4f-4bf1-8a12-fa39892317bc2024-10-02WarningsExact identifier
application number: M017
Geliga MuscularMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAfb2beb08-0ad6-a89d-e053-6294a90aa6fe2024-10-02WarningsExact identifier
application number: M017
Geliga Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAda28097f-4b5c-6159-e053-2a95a90a7d962024-10-02WarningsExact identifier
application number: M017
CircatrixCAPSAICINPureTek Corporationcd3b1256-2df8-dc26-e053-2a95a90ad0492024-10-02WarningsExact identifier
application number: M017
DermacinRx Penetral CreamCAPSAICINPureTek Corporation1e343a52-6071-3230-e054-00144ff8d46c2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEBorden Company (Private) Limited36abfc2c-d424-4df8-968d-866342c96a562024-10-02WarningsExact identifier
application number: M017
Eagle BalmCAMPHOR MENTHOLEagle Indo Pharma, PT87614869-9675-2c76-e053-2a95a90a48a92024-10-02WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limitedd9a93daa-4e24-6690-e053-2a95a90a147c2024-10-02WarningsExact identifier
application number: M017
Eagle Extra StrengthMENTHOL METHYL SALICYLATEBorden Company (Private) Limited5e02fbe3-5bc7-430e-b661-3a760ddd8fe02024-10-02WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEBorden Company (Private) Limitedc62a4313-2c07-5f58-e053-2995a90a083a2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEEagle Indo Pharma, PTe272ec90-3cd9-5b70-e053-2a95a90a1df42024-10-02WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilPSN1c3e5068-dd61-ebdb-e063-6294a90a97cc2
1654728camphor 70 MG/ML / menthol 160 MG/ML / methyl salicylate 350 MG/ML Topical OilSCD1c3e5068-dd61-ebdb-e063-6294a90a97cc2
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilSY1c3e5068-dd61-ebdb-e063-6294a90a97cc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43405-017-08434050017081 BOTTLE, GLASS in 1 BOX (43405-017-08) / 8 mL in 1 BOTTLE, GLASS2023-11-01NoNoCurrent