Eagle Brand

Product NDC
43405-012
11-digit product format
434050012
Labeler code
43405
Product ID
43405-012_4e5d63b2-eefe-e63d-e063-6394a90aa14e
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, menthol
Dosage form
OIL
Route
TOPICAL
Labeler
Borden Company (Private) Limited
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-01
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
2.2; 14 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 Refresh
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)2.2 g/100mL
MENTHOL14 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
2672336Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
091451fb-e30a-0012-e063-6394a90a3ba8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43405-012-08Eagle BrandMedicated Roll On Refresh1 in 1 BOXOIL12
43405-012-08Eagle BrandMedicated Roll On Refresh8 mL in 1 BOTTLE, GLASSOIL82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-012EAGLE BRAND MEDICATED ROLL ON REFRESH (CAMPHOR, MENTHOL) OIL [BORDEN COMPANY (PRIVATE) LIMITED]1Current NDC, 2 package rows20240102_091451fb-e30a-0012-e063-6394a90a3ba8.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 121 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Pain Relieving Plus Turmeric AnalgesicTROLAMINE SALICYLATEWalgreen Companyf3a121bc-7572-49a4-9822-2b6d858c19d22024-10-31WarningsExact identifier
application number: M017
dg health hydrocortisoneHYDROCORTISONEDolgencorp, LLC27dc9e09-fc4f-4b66-a303-177725f3a5132024-10-31WarningsExact identifier
application number: M017
basic care hydrocortisoneHYDROCORTISONEAmazon.com Services LLCf5419859-3f9f-43ff-9a3f-6aa81af044f02024-10-31WarningsExact identifier
application number: M017
ARCTIC RELIEFMENTHOL, UNSPECIFIED FORMSTRATUS PHARMACEUTICALS INCd27fbc17-46b7-4d52-ba29-c99b6c63144a2024-10-31WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINE, MENTHOLR & Y Group, LLCfe0478d8-2f06-cd56-e053-6294a90a58e52024-10-30WarningsExact identifier
application number: M017
JOINT-RITIS PAIN RELIEVING ROLL-ONMENTHOLLifeline Naturals of America, Inc.ec5d99c4-6bba-45d1-84e0-12fb7cb314952024-10-30WarningsExact identifier
application number: M017
Walgreens Pain Relieving with Turmeric AnalgesicLIDOCAINE HYDROCHLORIDEWalgreen Company317ec4fb-cff0-461d-9ca0-299527a3686d2024-10-30WarningsExact identifier
application number: M017
Walgreens Pain Relieving AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEWalgreen Company3215a676-104c-43c3-aa36-b30d5b67799a2024-10-30WarningsExact identifier
application number: M017
Ultra-Strength Pain Relief AnalgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMTARGET CORPORATION159c5a84-bf68-41dd-a2d3-bc24020372442024-10-30WarningsExact identifier
application number: M017
DG Health Cold n Hot Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMDolgencorp Inc8fe13b85-ab74-42f8-a664-d3d2959921ac2024-10-30WarningsExact identifier
application number: M017
DEBACHERE Butt Balm After Care Antiseptic Pain ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLC8ba42864-69bf-455c-98d4-7f4ff94edceb2024-10-29WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafewaybeefab66-b056-4bf1-b047-0780704ab87e2024-10-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEH E B15eb4676-5f6e-4c28-b5b9-4e45412dc37a2024-10-29WarningsExact identifier
application number: M017
Rael PAIN RELIEF ROLL-ON AnalgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMRael, Inc.e6c49606-7c13-4dc6-a22d-ba54173ba7882024-10-28WarningsExact identifier
application number: M017
Monistat Care Instant Itch ReliefBENZOCAINEInsight Pharmaceuticals LLC4e9dc791-419f-4c79-aed4-760f8c17a5dd2024-10-25WarningsExact identifier
application number: M017
ZYLOTROL PAIN RELIEVINGLIDOCAINE HCL, MENTHOLAsclemed USA, Inc.1553351c-aee8-4c40-9548-35cce246bda92024-10-25WarningsExact identifier
application number: M017
OutgroBENZOCAINEMedtech Products Inc.d6be8a1d-aca7-42b1-86da-881d42ffe8d52024-10-25WarningsExact identifier
application number: M017
Monistat Complete Care Instant Itch ReliefHYDROCORTISONEInsight Pharmaceuticals LLCa0f40504-6183-4f32-8d17-6586b3f386a62024-10-25WarningsExact identifier
application number: M017
Boil EaseBENZOCAINEInsight Pharmaceuticals LLCbf108934-5e1a-4059-9dcf-008f52a83fab2024-10-25WarningsExact identifier
application number: M017
Dermarest Eczema MedicatedHYDROCORTISONEInsight Pharmaceuticals LLC0292ab62-5088-45fa-a056-70c2fcc19ef72024-10-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2672336camphor 2.2 % / menthol 14 % Topical OilPSN091451fb-e30a-0012-e063-6394a90a3ba82
2672336camphor 22 MG/ML / menthol 140 MG/ML Topical OilSCD091451fb-e30a-0012-e063-6394a90a3ba82
2672336camphor 2.2 % / menthol 14 % Topical OilSY091451fb-e30a-0012-e063-6394a90a3ba82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43405-012-08434050012081 BOTTLE, GLASS in 1 BOX (43405-012-08) / 8 mL in 1 BOTTLE, GLASS2023-11-01NoNoCurrent