FDA.reportPublic FDA data

Peppermint soothing cream

Product NDC
85305-001
11-digit product format
853050001
Labeler code
85305
Product ID
85305-001_2f6bc332-3007-710d-e063-6394a90acea5
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOL
Dosage form
PASTE
Route
TOPICAL
Labeler
Henan Lijitang Medical Technology Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-13
Substance
CAMPHORIC ACID; MENTHOL, UNSPECIFIED FORM; BORNEOL
Active strength
3.5; 2; 1 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Peppermint soothing cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHORIC ACID3.5 g/100g
MENTHOL, UNSPECIFIED FORM2 g/100g
BORNEOL1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
32K0C7JGCJInternal UNII lookup
L7T10EIP3AInternal UNII lookup
M89NIB437XInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f6bc332-3006-710d-e063-6394a90acea5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85305-001-01Peppermint soothing cream30 g in 1 BOTTLEPASTE301
85305-001-01Peppermint soothing cream1 in 1 BOXPASTE11
85305-001-02Peppermint soothing cream1 in 1 BOXPASTE11
85305-001-02Peppermint soothing cream50 g in 1 BOTTLEPASTE501
85305-001-03Peppermint soothing cream100 g in 1 BOTTLEPASTE1001
85305-001-03Peppermint soothing cream1 in 1 BOXPASTE11
85305-001-04Peppermint soothing cream120 g in 1 BOTTLEPASTE1201
85305-001-04Peppermint soothing cream1 in 1 BOXPASTE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85305-001PEPPERMINT SOOTHING CREAM (CAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOL) PASTE [HENAN LIJITANG MEDICAL TECHNOLOGY CO., LTD.]1Current NDC, 8 package rows20250316_2f6bc332-3006-710d-e063-6394a90acea5.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 70 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coralite Ultra Strength Pain ReliefCAMPHOR MENTHOLUnited Exchange Corp.44ecf959-cc07-4adc-a500-075b2ee695482025-10-29WarningsExact identifier
application number: M017
GoodSense Pain ReliefLIDOCAINEGeiss, Destin & Dunn, Inc826f8da4-8468-ea0a-e053-2991aa0a66cb2025-10-28WarningsExact identifier
application number: M017
CALMADOLCAMPHOR, MENTHOL, METHYL SALICYLATEGRANDALL DISTRIBUTING, LLC31b7f84e-8b66-4d31-8e9c-279d0af2fe642025-10-28WarningsExact identifier
application number: M017
XRay DOLCAMPHOR, MENTHOL, AND METHYL SALICYLATEGenomma Lab USA, Inc.e07fef46-68d9-769c-e053-2a95a90aa0652025-10-28WarningsExact identifier
application number: M017
CVS Medicated HeatCAPSICUM EXTRACTCVS Pharmacy81cd1019-93a6-311b-e053-2991aa0a79972025-10-28WarningsExact identifier
application number: M017
Foster and ThriveLIDOCAINESTRATEGIC SOURCING SERVICES, LLCf950b072-d978-b629-e053-6394a90abfaf2025-10-28WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
application number: M017
PRMENTHOLAmphp, Inc6f5b9e08-c445-4fac-e053-2a91aa0aa7372025-10-27WarningsExact identifier
application number: M017
LidocaineBURN RELIEFFoodhold USAb25dc0df-02d0-41ac-b36c-2c04baa77ef22025-10-27WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREEFSA Store Inc.fb3548c8-f202-dc50-e053-6394a90a5b302025-10-27WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE CONTINUOUS SPRAYPremier Brands of America, Inc.d344f68b-9b62-3029-e053-2995a90a16652025-10-27WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATE 1%Unifirst First Aid Corporationf2b46d69-1c21-5ae9-e053-2a95a90a60a92025-10-24WarningsExact identifier
application number: M017
Extra StrengthMENTHOL AND METHYL SALICYLATESaje Natural Business Inc.87d872b3-3231-d0f2-e053-2995a90a9d982025-10-24WarningsExact identifier
application number: M017
Coralite Muscle and Joint Pain ReliefCAMPHOR, MENTHOL, AND MEHTYL SALICYLATEUnited Exchange Corporation78edeeb8-3e3c-64bb-e053-2a91aa0a7bbc2025-10-24WarningsExact identifier
application number: M017
Coralite Odor Free Pain ReliefLIDOCAINEUnited Exchange Corporation7966d9f2-22f9-a900-e053-2991aa0aba552025-10-24WarningsExact identifier
application number: M017
Signature Care Cold and HotMENTHOL, AND METHYL SALICYLATESafeway Inc.ab201023-e3dc-52ec-e053-2995a90a1f182025-10-24WarningsExact identifier
application number: M017
HealthWise Medicated Cold Hot 5% PatchMENTHOLVeridian Healthcare15aef56f-cd25-05ac-e063-6394a90a07bb2025-10-23WarningsExact identifier
application number: M017
AlivioLIDOCAINEAmerise Pharmaceuticals LLCeb3a98f1-c875-4f08-8b4b-44e22626b6092025-10-23WarningsExact identifier
application number: M017
Pain Relieveing Gel-PatchLIDOCAINEBullet point LLC41d507c4-ad37-2686-e063-6394a90aae5b2025-10-23WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP98fa9a34-0e1e-0997-e053-2a95a90ac77d2025-10-23WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85305-001-01853050001011 BOTTLE in 1 BOX (85305-001-01) / 30 g in 1 BOTTLE1 bottle2025-03-13NoNoCurrent
85305-001-02853050001021 BOTTLE in 1 BOX (85305-001-02) / 50 g in 1 BOTTLE1 bottle2025-03-13NoNoCurrent
85305-001-03853050001031 BOTTLE in 1 BOX (85305-001-03) / 100 g in 1 BOTTLE1 bottle2025-03-13NoNoCurrent
85305-001-04853050001041 BOTTLE in 1 BOX (85305-001-04) / 120 g in 1 BOTTLE1 bottle2025-03-13NoNoCurrent