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 138 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MED O-3 BIO-METHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC02707552-03d9-3ad2-e063-6294a90a34722024-01-06WarningsExact identifier
application number: M017
Sumifun Knee Relieving PatchKNEE RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0e7e73ec-ab33-9235-e063-6394a90ad9502024-01-06WarningsExact identifier
application number: M017
Lidocaine Numbing CreamLIDOCAINEYYBA Corpde6dc194-c6ef-4cb5-be3f-e772ace9abaf2024-01-03WarningsExact identifier
application number: M017
Equate Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMWalmart Inc.0cdc9323-f5c3-468c-a7ae-83dfd2d766262024-01-03WarningsExact identifier
application number: M017
OWELL NATURALS Deep Penetrating Pain ReliefMENTHOLOWELL NATURALS BRAND, LLCb36eb017-ed8d-476e-994b-22b275e005432024-01-02WarningsExact identifier
application number: M017
DibucaineDIBUCAINE 1%Trifecta Pharmaceuticals USA LLCe8a56651-a292-7609-e053-2a95a90a7c362024-01-02WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Trifecta Pharmaceuticals USA, LLC.44d17651-a31b-64ca-e054-00144ff8d46c2024-01-02WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.e0a13344-5493-eb51-e053-2995a90a81832024-01-02WarningsExact identifier
application number: M017
Sumifun Knee Relieve PatchKNEE RELIEVE PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0e031aa5-edf4-8c9d-e063-6394a90afee32024-01-02WarningsExact identifier
application number: M017
OKeeffes Healthy FeetALLANTOIN, LIDOCAINEThe Gorilla Glue Company/O'Keeffe's Companyd73709db-3932-3c56-e053-2995a90a7d0a2024-01-01WarningsExact identifier
application number: M017
PERSONAL CARE ICE COLDMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.1994356c-e347-5b7d-e063-6394a90a476c2024-01-01WarningsExact identifier
application number: M017
Dendracin NeurodendraxcinMETHYL SALICYLATE, MENTHOL AND CAPSAICINProficient Rx LP7e765fc1-74c6-4af3-a9cf-05b57011d7d82024-01-01WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Incc6a0880e-fc16-46e9-8314-c56c9d15bf312023-12-31WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Anti ItchHYDROCORTISONEL'Oreal USA Products Inc.8d65e945-2557-486f-9279-ecbaa08f31c42023-12-31WarningsExact identifier
application number: M017
Nighttime Sleep-Aid Non-Habit FormingDIPHENHYDRAMINE HCIAptaPharma Inc.ed0ba7aa-e794-43da-b576-6b9945bf74772023-12-30WarningsExact identifier
application number: M017
Sting-KillBENZOCAINE AND MENTHOLRANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTHb8bd9280-f20a-4b2a-aef7-a0ba7b3b87012023-12-29WarningsExact identifier
application number: M017
Maybelline New York Baby Lips Dr Rescue Medicated BalmMENTHOLL'Oreal USA Products Inc2f7b8221-66f6-4aed-8359-318cfc656a722023-12-28WarningsExact identifier
application number: M017
Equate CortisoneHYDROCORTISONE 1%Walmart Inc027fae33-93a0-a61f-e063-6294a90a990f2023-12-27WarningsExact identifier
application number: M017
Walgreens Cool n Heat LidocaineLIDOCAINE HCL 4%Walgreens Co0681c6c5-5a8b-ea9e-e063-6394a90a83bc2023-12-27WarningsExact identifier
application number: M017
EXTRA STRENGTH WAL-DRYL ITCH RELIEFDIPHENHYDRAMINE, ZINC ACETATEWALGREEN CO681cf1af-2cc3-4e6d-b76f-f00731ea3e122023-12-27WarningsExact 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