FDA.reportPublic FDA data

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 84 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SYNC ICESYNC RELIEF ICEiON Pharma, LLC38ce98ce-a7bf-8041-e063-6394a90ae7302025-07-28WarningsExact identifier
application number: M017
SYNC PROSYNC RELIEF PRO CREAMiON Pharma, LLC3a3e91d6-732b-dca9-e063-6394a90a06d42025-07-28WarningsExact identifier
application number: M017
Careland Pain ReliefMETHYL SALICYLATE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.83f36771-1033-4fd0-a0e6-82c1dcfedeee2025-07-28WarningsExact identifier
application number: M017
Rite Aid anti-itchHYDROCORTISONERite Aid Corporation2a232dd1-9071-4c55-a7f7-19d8404b99a62025-07-28WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONERITE AID CORPORATION05598255-3e7a-46a5-ae7e-dcfcb616d59d2025-07-28WarningsExact identifier
application number: M017
Inked InspiredLIDOCAINE HCLProdigy Media Inc54fb2860-7e63-4598-953a-170226e613e92025-07-28WarningsExact identifier
application number: M017
Ujhay Hydrocortisone Ointment.UJHAY HYDROCORTISONE OINTMENTGuangdong Quadrant Ecological Technology Co., Ltd.3af59276-8e6a-0603-e063-6394a90a1f9b2025-07-27WarningsExact identifier
application number: M017
SANA SANA Menthol External AnalgesicMENTHOLAlquimia Najulam S de RL de CV8b7edd51-e08a-4e01-9df0-8305ce17b4182025-07-25WarningsExact identifier
application number: M017
Hydrocortisone Intensive Healing FormulaHYDROCORTISONETARGET Corporation682b737f-e453-4079-bf31-47a9485c78972025-07-25WarningsExact identifier
application number: M017
Chigg AwayBENZOCAINEPierson Laboratories, Inc.8372e7c1-f145-4bc5-85ab-cf831abe70ce2025-07-24WarningsExact identifier
application number: M017
Chigg AwayBENZOCAINEPharma Nobis, LLCe42fa1c6-d804-630f-e053-2995a90add6b2025-07-24WarningsExact identifier
application number: M017
Cannarelief 2000mgMENTHOLEarthmed LLC01f810de-52ba-8beb-e063-6394a90a61c02025-07-24WarningsExact identifier
application number: M017
CHING WAN HUNG SOOTHING HERBAL BALMMENTHOLTIANJIN DARENTANG JINGWANHONG PHARMACEUTICAL CO., LTD.ffadc904-8e9d-4cb8-815a-d583bbdb3f0b2025-07-24WarningsExact identifier
application number: M017
PT Elite Premium Pain ReliefCAPSAICIN, MENTHOLPT ELITE PRODUCTS LLCad251821-4c58-425d-bdcb-8dd9bd41b7132025-07-23WarningsExact identifier
application number: M017
Whipped Butter SPF 50ZINC OXIDEBloomeffects, Inc374b62d8-e012-591f-e063-6294a90aef932025-07-23WarningsExact identifier
application number: M017
Game On XtremeMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.5a1b6192-d537-42b3-add8-22c63e7c986c2025-07-23WarningsExact identifier
application number: M017
AMRUTANJAN RELIEF PAIN BALMCAMPHOR , MENTHOL, METHYL SALICYLATEAMRUTANJAN HEALTH CARE LIMITEDddee6714-8b18-4d87-944b-8467fda22e6b2025-07-23WarningsExact identifier
application number: M017
Stopain Extra Strength GelMENTHOLTroy Manufacturing, Inc.8bb89002-d7a2-4bee-b5a5-1fd1949273ef2025-07-22WarningsExact identifier
application number: M017
Hielo ArdienteMENTHOLMenper Distributors, Inc.97ec516c-d2bc-47ce-82fe-bd68445d95702025-07-22WarningsExact identifier
application number: M017
La Flecha JaponesaMETHYL SALICYLATEMenper Distributors, Inc.08819ad0-97c2-49bd-b923-535b94a271672025-07-22WarningsExact 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