FDA.reportPublic FDA data

Eagle Brand

Product NDC
43405-099
11-digit product format
434050099
Labeler code
43405
Product ID
43405-099_54e45d89-e8c4-6fc3-e063-6394a90aac4e
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
2015-06-15
Substance
METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
34.23; 15.648; 6.846 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 Oil Aromatic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE34.23 g/100mL
MENTHOL15.648 g/100mL
CAMPHOR (SYNTHETIC)6.846 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
L7T10EIP3AInternal UNII lookup
5TJD82A1ETInternal 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
54e45d89-e8c3-6fc3-e063-6394a90aac4eAvailable on FDA.report

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 10 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gaayou NumbingDIBUCAINE HYDROCHLORIDE 0.5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4c290118-7880-2a98-e063-6294a90a4c032026-07-21WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain Relieving Cold GelCAMPHOR, MENTHOLActive and Innovative572792bb-2819-36c3-e063-6394a90aa5042026-07-21WarningsExact identifier
application number: M017
SYLVIRENE NUMBINGLIDOCAINE 4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a36edc5-5a89-afb5-e063-6294a90a02dd2026-07-21WarningsExact identifier
application number: M017
REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAINLIDOCAINE 4% PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAINJiangxi Yudexi Pharmaceutical Co., LTD4a45c1cb-c5ab-d872-e063-6394a90aab5d2026-07-21WarningsExact identifier
application number: M017
SERYNTH Muscle ComfortARNICA MONTANA HPUS 7% MUSCLE COMFORTJiangxi Yudexi Pharmaceutical Co., LTD4a4c10cd-f0c4-8731-e063-6394a90a10a52026-07-21WarningsExact identifier
application number: M017
DERMFREE MEDICATED LIPCAMPHOR 2.0% MEDICATED LIPJiangxi Yudexi Pharmaceutical Co., LTD4a4d62fb-8dfa-404a-e063-6294a90a385d2026-07-21WarningsExact identifier
application number: M017
NATUHEAL RELIEF Cream FOR ECZEMAHYDROCORTISONE ACETATE 1% RELIEF CREAM FOR ECZEMAJiangxi Yudexi Pharmaceutical Co., LTD4c92fed1-a8b4-bda8-e063-6394a90a8a332026-07-20WarningsExact identifier
application number: M017
REDCOOL Arnica BruiseARNICA MONTANA HPUS 7% ARNICA BRUISEJiangxi Zhongletang Pharmaceuticals Co.,Ltd.49911392-e55e-1a6b-e063-6394a90a9af02026-07-20WarningsExact identifier
application number: M017
Vamy HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD499197aa-f872-3abf-e063-6294a90aeda22026-07-20WarningsExact identifier
application number: M017
Subleef NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a201a6b-adde-c0a8-e063-6394a90a82852026-07-20WarningsExact identifier
application number: M017
PUVIDA NUMBINGMENTHOL 5% (W/W) NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4de4e317-2f4f-e5d6-e063-6394a90a06112026-07-20WarningsExact identifier
application number: M017
Careland Lidocaine Plus Menthol Pain Relieving Gel PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.8b607c03-a98f-445a-a69e-7625a76ac44b2026-07-20WarningsExact identifier
application number: M017
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M017
VBBV NumbingLIDOCAINEJiashen International Trade Limited5716c36b-6e97-c294-e063-6394a90aaf5c2026-07-20WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEPremier Brands of America Inc.560c29cc-2453-5d14-e063-6394a90a844f2026-07-17WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.4981e9c3-2a19-aed8-e063-6294a90af2162026-07-17WarningsExact identifier
application number: M017
endurance wipeBENZOCAINEAbsorption Pharmaceuticals, LLC303db1de-94fc-4543-e063-6294a90a01b92026-07-17WarningsExact identifier
application number: M017
Professional Therapy MuscleCare pain relieving gel Extra StrengthCAMPHOR, MENTHOLActive and Innovative Inc.56d30c33-ef5a-c63d-e063-6294a90acd292026-07-17WarningsExact identifier
application number: M017
Mineral Ice Extreme Gel Alpine Fresh ScentMENTHOLCarlin Consumer Health LLC56d3ca3d-21e1-a40a-e063-6294a90a9ff42026-07-17WarningsExact identifier
application number: M017
DRAVYNOR TOPICAL ANALGESIC HEAT PatchMENTHOL 24MG CAPSAICIN 16MG TOPICAL ANALGESIC HEAT PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56b83ee8-8d86-9436-e063-6294a90a0c252026-07-16WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43405-099-03434050099031 BOTTLE, GLASS in 1 BOX (43405-099-03) / 3 mL in 1 BOTTLE, GLASS2015-06-15NoNoCurrent
43405-099-24434050099241 BOTTLE, GLASS in 1 BOX (43405-099-24) / 24 mL in 1 BOTTLE, GLASS2015-06-15NoNoCurrent
43405-099-36434050099361 BOTTLE, GLASS in 1 BOX (43405-099-36) / 36 mL in 1 BOTTLE, GLASS2015-06-15NoNoCurrent