FDA.reportPublic FDA data

Eagle Brand

Product NDC
43405-017
11-digit product format
434050017
Labeler code
43405
Product ID
43405-017_2c2e4588-e839-9660-e063-6294a90af46e
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
2023-11-01
Substance
METHYL SALICYLATE; CAMPHOR (SYNTHETIC); MENTHOL
Active strength
35; 7; 16 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 Roll On Aromatic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE35 g/100mL
CAMPHOR (SYNTHETIC)7 g/100mL
MENTHOL16 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
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
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
1c3e5068-dd61-ebdb-e063-6294a90a97ccAvailable 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
43405-017-08Eagle BrandMedicated Roll On Aromatic8 mL in 1 BOTTLE, GLASSOIL82
43405-017-08Eagle BrandMedicated Roll On Aromatic1 in 1 BOXOIL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-017EAGLE BRAND MEDICATED ROLL ON AROMATIC (CAMPHOR, MENTHOL, METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED]2Current NDC, 2 package rows20250122_1c3e5068-dd61-ebdb-e063-6294a90a97cc.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 151 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEZhejiang Jingwei Pharmaceutical Co., Ltd.fefbe351-1cd9-4a2f-a43d-51e2c4eb180b2023-10-24WarningsExact identifier
application number: M017
TheraPlus PlusMENTHOLZhejiang Jingwei Pharmaceutical Co., Ltd.d4119f84-eb60-4134-b58e-de13d96011992023-10-24WarningsExact identifier
application number: M017
Family WellnessHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.cddc9c4a-7c58-4225-921a-05d6afb491782023-10-24WarningsExact identifier
application number: M017
NUMOTIZINEMENTHOLHobart Laboratories, Inc.9a29ad1b-4ba3-403f-90c9-ee7582fe45352023-10-20WarningsExact identifier
application number: M017
Numfast Tetracaine GreenTETRACAINEUnit Dose, Ltd.77d9e6ea-1cd3-4447-ba74-01cd7143e27c2023-10-19WarningsExact identifier
application number: M017
LiprotekPETROLATUM, LIDOCAINEUnit Dose, Ltd.051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa52023-10-19WarningsExact identifier
application number: M017
GENUINE FIRST AID Antiseptic Pain RelievingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.bc7c6739-6068-4694-adc9-0c0c5c347df42023-10-19WarningsExact identifier
application number: M017
CVS Itch relief moisturizingPRAMOXINE HCL 1%CVS Healthf3a753fc-f448-6bba-e053-2a95a90a8e1b2023-10-18WarningsExact identifier
application number: M017
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Asclemed USA, Inc.e13984ea-73a9-2894-e053-2995a90a8ed62023-10-16WarningsExact identifier
application number: M017
EXOTEN-CMETHYL SALICYLATE, MENTHOL, CAPSAICINAsclemed USA, Inc.76ed37e0-64b5-4abe-a03c-3dc7084a39192023-10-16WarningsExact identifier
application number: M017
Calypxo Pain ReliefMETHYL SALICYLATE, MENTHOLAsclemed USA, Incbd9d0bc0-5705-4c73-bcd6-f6cdb68e05b62023-10-16WarningsExact identifier
application number: M017
Calypxo HP Pain ReliefMETHYL SALICYLATE, MENTHOLAsclemed USA, Inc89a8c267-bd92-4d0d-8e50-c52224aff9cd2023-10-16WarningsExact identifier
application number: M017
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Whitestone Products LLC0e32e9c0-ff5b-4e88-89b1-f5903cd982092023-10-16WarningsExact identifier
application number: M017
CapsadynCAPSAICINChorda Pharma, Inc07731045-0d2b-76b7-e063-6294a90af9212023-10-11WarningsExact identifier
application number: M017
WHITE FLOWER STRAIN RELIEFCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTD65282267-de63-453a-a686-f8752c71b9ef2023-10-02WarningsExact identifier
application number: M017
WHITE FLOWER ANALGESIC BALM FLORAL SCENTEDCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTD4e9cb5aa-b0aa-4a5c-b561-cc38437758d82023-10-02WarningsExact identifier
application number: M017
NATUREANCE BODY BALMCAMPHOREROS GLOBAL CORP05b84fd2-8d8f-9249-e063-6294a90ae29f2023-09-19WarningsExact identifier
application number: M017
U ICE COLDMENTHOLUNIVERSAL DISTRIBUTION CENTER LLC752ef0cd-f12a-3b9e-e053-2991aa0abeb12023-09-01WarningsExact identifier
application number: M017
Family Wellness Pain Relief with LidocainePAIN RELIEF WITH LIDOCAINEFAMILY DOLLAR (Family Wellness)3a18119f-6c75-4cea-a990-97cb8a9589d42023-08-29WarningsExact identifier
application number: M017
Bactine Max Antibiotic and Lidocaine Max Pain ReliefLIDOCAINEWellSpring Pharmaceutical Corporation71300df9-6113-4f25-93ca-28ad7e7f79de2023-06-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilPSN1c3e5068-dd61-ebdb-e063-6294a90a97cc2
1654728camphor 70 MG/ML / menthol 160 MG/ML / methyl salicylate 350 MG/ML Topical OilSCD1c3e5068-dd61-ebdb-e063-6294a90a97cc2
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilSY1c3e5068-dd61-ebdb-e063-6294a90a97cc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43405-017-08434050017081 BOTTLE, GLASS in 1 BOX (43405-017-08) / 8 mL in 1 BOTTLE, GLASS2023-11-01NoNoCurrent