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 75 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AREX SINSIN PASCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.2013ea44-e2ea-4b36-bddb-7f64163284b62025-10-07WarningsExact identifier
application number: M017
SINSINPAS LIDOCAINE PAIN RELIEVINGLIDOCAINESinsin Pharmaceutical Co., Ltd.82c0a036-8750-5b3d-e053-2a91aa0a18152025-10-07WarningsExact identifier
application number: M017
SINSIN MULPASL-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR, CHLORPHENIRAMINE MALEATE, THYMOLSinsin Pharmaceutical Co., Ltd.81baffcb-c08e-4616-e053-2a91aa0aaf152025-10-07WarningsExact identifier
application number: M017
Arex Sinsin PasCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.a851854a-5dfe-4bd5-95f6-67c3f13f11872025-10-07WarningsExact identifier
application number: M017
Sinsinpas Arex Flex Gel Pain Relieving PatchL-MENTHOLSinsin Pharmaceutical Co., Ltd.1758ef9b-4fac-4066-e063-6394a90a8cc32025-10-07WarningsExact identifier
application number: M017
SINSINPAS CORN REMOVERSALICYLIC ACIDSinsin Pharmaceutical Co., Ltd.e2771dfc-ee57-553f-e053-2a95a90af2812025-10-07WarningsExact identifier
application number: M017
Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)aa6cc963-dc60-5222-e053-2995a90acaf62025-10-06WarningsExact identifier
application number: M017
TheraCare 2% Diphenhydramine Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEVeridian Healthcare5999b677-63dd-49c6-b5b8-7b3c117ecc5c2025-10-06WarningsExact identifier
application number: M017
HealthWise Pain ReliefMENTHOLVeridian Healthcare06be5331-7a1e-4ab3-9f17-2d350bd4b8902025-10-02WarningsExact identifier
application number: M017
equate Burn ReliefLIDOCAINE HYDROCHLORIDEWalmart Inca90cbd92-80a5-4463-8152-b83165121a6f2025-10-02WarningsExact identifier
application number: M017
AsperFlex HOTCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.a6cb0656-8866-44ff-b40c-73655ff687212025-10-02WarningsExact identifier
application number: M017
AsperFlex Original Maximum StrengthMENTHOLAkron Pharma Inc.d766c61e-c48b-4aff-97b0-678159479e032025-10-02WarningsExact identifier
application number: M017
HealthWise Feminine Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare1f9110da-f448-8e20-e063-6294a90a42752025-10-02WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCdc704403-e2aa-47f7-a7f4-f6afe1547ca82025-10-01WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCe02558a9-fe2b-4f28-9fd3-7308f859d7592025-10-01WarningsExact identifier
application number: M017
FL Burn Ease, 0.9gLIDOCAINEProStat First Aid LLC4dc0d579-ab42-4ea5-9788-5e54d7d318a32025-10-01WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.c7a7626c-cf82-4301-af79-c5e85367e7772025-10-01WarningsExact identifier
application number: M017
Viaderma Calm Anti-ItchHYDROCORTISONEViaDerma Distribution, Inc.7afa2ccd-bfc6-48fc-9a14-a0c6d645844e2025-10-01WarningsExact identifier
application number: M017
AsperFlex AdvanceCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.d23d7f2b-4dcd-4c31-9d12-340f233018b42025-10-01WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INC4024d604-c8c7-2d73-e063-6294a90a2e802025-10-01WarningsExact 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