FDA.reportPublic FDA data

Eagle

Product NDC
60954-007
11-digit product format
609540007
Labeler code
60954
Product ID
60954-007_238af46a-9570-d599-e063-6394a90aa767
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor Menthol Methyl Salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
Eagle Indo Pharma, PT
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-20
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
7; 16; 35 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 name suffix
Medicated Aromatic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)7 g/100mL
MENTHOL16 g/100mL
METHYL SALICYLATE35 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal 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
e272ec90-3cd9-5b70-e053-2a95a90a1df4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-007-03EagleMedicated Aromatic1 in 1 BOXOIL12
60954-007-03EagleMedicated Aromatic3 mL in 1 BOTTLE, GLASSOIL32
60954-007-08EagleMedicated Aromatic1 in 1 BOXOIL12
60954-007-08EagleMedicated Aromatic8 mL in 1 BOTTLE, GLASSOIL82
60954-007-12EagleMedicated Aromatic1 in 1 BOXOIL12
60954-007-12EagleMedicated Aromatic12 mL in 1 BOTTLE, GLASSOIL122
60954-007-24EagleMedicated Aromatic1 in 1 BOXOIL12
60954-007-24EagleMedicated Aromatic24 mL in 1 BOTTLE, GLASSOIL242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-007EAGLE MEDICATED AROMATIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [EAGLE INDO PHARMA, PT]2Current NDC, Legacy NDC, 8 package rows20241004_e272ec90-3cd9-5b70-e053-2a95a90a1df4.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 92 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Numbing CreamLIDOCAINE100 KARMA INC359884d6-188a-e503-e063-6294a90acab42025-05-20WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO - THERMOACTIVE LOTION835abc66-680f-be06-e053-2a91aa0a309e2025-05-19WarningsExact identifier
application number: M017
Numbing CreamLIDOCAINE100 KARMA INC35884644-d017-eda3-e063-6394a90a1f6c2025-05-19WarningsExact identifier
application number: M017
QUIT SMOKING Proven PatchesNICOTINEJiashen International Trade Limited35570155-c769-dc4c-e063-6394a90a019d2025-05-17WarningsExact identifier
application number: M017
VBBV Tattoo NumbingLIDOCAINEJiashen International Trade Limited3557859e-f8b3-1049-e063-6394a90ad7372025-05-17WarningsExact identifier
application number: M017
Bliss Republic Lidocaine Numbing CreamLIDOCAINE NUMBING CREAMSargass Group Limited Liability Company35415851-beba-5bb4-e063-6294a90a35c02025-05-16WarningsExact identifier
application number: M017
Cold Hot Chinese Red Tiger Pain Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd352798e1-1e09-3d47-e063-6394a90ad4042025-05-15WarningsExact identifier
application number: M017
Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd35285d62-c660-a056-e063-6294a90aabc82025-05-15WarningsExact identifier
application number: M017
SionBiotext HydrocortisoneHYDROCORTISONE ACETATE 1%Sion Biotext Medical Ltd35073eae-26fe-2bb5-e063-6294a90ab56a2025-05-13WarningsExact identifier
application number: M017
Bliss Republic Lidocaine Numbing CreamLIDOCAINE NUMBING CREAMSargass Group Limited Liability Company3508ae14-d9c9-3c85-e063-6294a90a00982025-05-13WarningsExact identifier
application number: M017
SORE NO MORE WARM THERAPYMENTHOL AND CAMPHORSOMBRA COSMETICS INC.cd86b56e-9b4c-4aca-9740-c8793cb120552025-05-12WarningsExact identifier
application number: M017
SORE NO MORE COOL THERAPYMENTHOLSOMBRA COSMETICS INC.9aa1f0ac-3baf-4e45-9e3a-c28a99b229092025-05-12WarningsExact identifier
application number: M017
Calm and Correct Serum with LidocaineLIDOCAINE 3 PERCENTRenu Laboratories, LLCddcf1c2e-2f67-44d7-e053-2a95a90a812b2025-05-09WarningsExact identifier
application number: M017
Mqupin Knee PatchKNEE PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd09772e4b-8193-3771-e063-6394a90a95162025-05-08WarningsExact identifier
application number: M017
Hydrocortisone CreamHYDROCORTISONETrifecta Pharmaceuticals USAd57a59fb-c8f2-f73b-e053-2995a90a4cdb2025-05-08WarningsExact identifier
application number: M017
Hydrocortisone CreamHYDROCORTISONETrifecta Pharmaceuticals USA4c96ec41-841c-322b-e054-00144ff8d46c2025-05-08WarningsExact identifier
application number: M017
GNP Extra Strength Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEAmerisource Bergen34a66224-ef3c-e36e-e063-6394a90ac99d2025-05-08WarningsExact identifier
application number: M017
Good Neighbor Muscle Rub CreamCAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%,Amerisource Bergen34924bb9-e3e8-70e6-e063-6294a90aaa8c2025-05-07WarningsExact identifier
application number: M017
DermaRad Relief Post Radiation CalmingLIDOCAINE 3 PERCENTRenu Laboratories, LLCe5d64929-fb9c-7ebc-e053-2995a90a93182025-05-07WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLInterMed Laboratories Private Limited33ee0235-5a6e-0ea1-e063-6394a90a89a52025-05-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilPSNe272ec90-3cd9-5b70-e053-2a95a90a1df42
1654728camphor 70 MG/ML / menthol 160 MG/ML / methyl salicylate 350 MG/ML Topical OilSCDe272ec90-3cd9-5b70-e053-2a95a90a1df42
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilSYe272ec90-3cd9-5b70-e053-2a95a90a1df42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60954-007-03609540007031 BOTTLE, GLASS in 1 BOX (60954-007-03) / 3 mL in 1 BOTTLE, GLASS2022-06-200000-00-00NoNoCurrent
60954-007-08609540007081 BOTTLE, GLASS in 1 BOX (60954-007-08) / 8 mL in 1 BOTTLE, GLASS2022-06-200000-00-00NoNoCurrent
60954-007-12609540007121 BOTTLE, GLASS in 1 BOX (60954-007-12) / 12 mL in 1 BOTTLE, GLASS2022-06-200000-00-00NoNoCurrent
60954-007-24609540007241 BOTTLE, GLASS in 1 BOX (60954-007-24) / 24 mL in 1 BOTTLE, GLASS2022-06-200000-00-00NoNoCurrent