FDA.reportPublic FDA data

Eagle Brand

Product NDC
43405-015
11-digit product format
434050015
Labeler code
43405
Product ID
43405-015_1b9fdac0-9fb1-e669-e063-6394a90aece9
Type
HUMAN OTC DRUG
Nonproprietary name
menthol, methyl salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
Borden Company (Private) Limited
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-24
Substance
METHYL SALICYLATE; MENTHOL
Active strength
30; 14.5 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 Oil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE30 g/100mL
MENTHOL14.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1293430Internal RxNorm lookup
1293435Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b9fdac0-9fb0-e669-e063-6394a90aece9Available 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
43405-015-24Eagle BrandMedicated Oil24 mL in 1 BOTTLE, GLASSOIL241
43405-015-24Eagle BrandMedicated Oil1 in 1 BOXOIL11
43405-015-36Eagle BrandMedicated Oil36 mL in 1 BOTTLE, GLASSOIL361
43405-015-36Eagle BrandMedicated Oil1 in 1 BOXOIL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-015EAGLE BRAND MEDICATED OIL (MENTHOL, METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED]1Current NDC, 4 package rows20240626_1b9fdac0-9fb0-e669-e063-6394a90aece9.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 26 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr SabharwalsLIDOCAINE 4% GEL PATCHDr. Sabharwal's Wound Care102399b6-5be9-ee5e-e063-6394a90a31982026-04-02WarningsExact identifier
application number: M017
TATTOO NUMBX NUMBING PAIN RELIEVINGLIDOCAINE HYDROCHLORIDEScyberco Ltdac8eac04-ed5b-4c8e-9f9b-54d160b746062026-04-02WarningsExact identifier
application number: M017
FifthPulse HydrocortisoneHYDROCORTISONEWeCare Products LLCf1fcb045-4a15-431b-9617-67eae9f87fbd2026-04-02WarningsExact identifier
application number: M017
ANIXIKE CreamMENTHOL 5% CREAMJiangxi Yudexi Pharmaceutical Co., LTD4e8510e6-c0c7-bf6b-e063-6294a90a3b002026-04-02WarningsExact identifier
application number: M017
RAPID RELIEF0.025% CAPSAICIN PAIN PATCH835694ed549e8-0062-fb03-e063-6294a90aac652026-04-02WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATECVS Pharmacy7e921988-ec66-38dc-e053-2a91aa0a73462026-04-01WarningsExact identifier
application number: M017
The Best Numbing CreamTBNCThe Best Numbing Cream LLC4ca3923b-f586-0aaf-e063-6294a90a16c12026-03-31WarningsExact identifier
application number: M017
ChapStick Classic MedicatedEXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALMSuave Brands Co., LLC42798a6c-2d7e-80f6-e063-6294a90a105f2026-03-31WarningsExact identifier
application number: M017
Roll-On Pain Relief LiquidLIDOCAINE HCLHyVee Inc4da6f6fb-b182-360f-e063-6294a90abdf32026-03-31WarningsExact identifier
application number: M017
Hand SanitizerALCOHOLProStat First Aid4e54aecb-190f-3866-e063-6294a90a810a2026-03-31WarningsExact identifier
application number: M017
Burn MistLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesc53ab9dd-351a-400b-b873-4f396e0af54d2026-03-31WarningsExact identifier
application number: M017
Satohap Lidocaine Hydrochloride 4 Percent Pain RelievingLIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.f7faddb2-5153-4fdd-a5ef-778182cef4602026-03-31WarningsExact identifier
application number: M017
ZENOL COOLMETHYL SALICYLATE, L-MENTHOLBA TRADE INC4e5c45f4-88ce-3a13-e063-6394a90a2a092026-03-31WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited091451fb-e30a-0012-e063-6394a90a3ba82026-03-31WarningsExact identifier
application number: M017
Icy Hot Revive and Recovery Pain Relief No- Mess Roll On Refreshing Lime and MintMENTHOLChattem, Inc.b16ba9c2-23bf-4fdf-b44b-7abb9fec19112026-03-31WarningsExact identifier
application number: M017
DR.PABU NUMBINGLIDOCAINE 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4e3a3c6c-4821-76ea-e063-6294a90a8f962026-03-30WarningsExact identifier
application number: M017
Doctor Jiao Antifungal CreamMICONAZOLE NITRATEJiangxi Haiwei Pharmaceutical Co., Ltd.4e3b231e-0642-bf63-e063-6394a90a905b2026-03-30WarningsExact identifier
application number: M017
CVS Muscle Balm and Roll-OnCAMPHOR, MENTHOLCVS Pharmacy4e40025a-070a-508e-e063-6394a90af5d72026-03-30WarningsExact identifier
application number: M017
REGENECARE HALIDOCAINE HCLMPM Medical LLCc3eec066-38e8-4617-b34d-2f72ffb7a3242026-03-30WarningsExact identifier
application number: M017
Softlips Naturals Medicated Matcha HoneyCAMPHOR, MENTHOLThe Mentholatum Company4e03a721-73f3-b2f2-e063-6394a90a44e62026-03-27WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293435EAGLE BRAND Medicated 14.5 % / 30 % Topical OilPSN1b9fdac0-9fb0-e669-e063-6394a90aece91
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilPSN1b9fdac0-9fb0-e669-e063-6394a90aece91
1293435menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]SBD1b9fdac0-9fb0-e669-e063-6394a90aece91
1293430menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical OilSCD1b9fdac0-9fb0-e669-e063-6394a90aece91
1293435Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical OilSY1b9fdac0-9fb0-e669-e063-6394a90aece91
1293435Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical OilSY1b9fdac0-9fb0-e669-e063-6394a90aece91
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilSY1b9fdac0-9fb0-e669-e063-6394a90aece91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43405-015-24434050015241 BOTTLE, GLASS in 1 BOX (43405-015-24) / 24 mL in 1 BOTTLE, GLASS2024-06-24NoNoCurrent
43405-015-36434050015361 BOTTLE, GLASS in 1 BOX (43405-015-36) / 36 mL in 1 BOTTLE, GLASS2024-06-24NoNoCurrent