FDA.reportPublic FDA data

REDCOOL Arnica Bruise

Product NDC
85248-026
11-digit product format
852480026
Labeler code
85248
Product ID
85248-026_5707c417-b73e-4bba-e063-6294a90a891e
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana HPUS 7% Arnica Bruise
Dosage form
CREAM
Route
TOPICAL
Labeler
Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-30
Substance
ARNICA MONTANA
Active strength
7 g/100g
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
REDCOOL Arnica Bruise
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA7 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O80TY208ZWInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
49911392-e55e-1a6b-e063-6394a90a9af0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-026-01REDCOOL Arnica Bruise120 g in 1 BOTTLECREAM1201

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 74 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nufabrx Medicine Infused SocksCAPSAICINNufabrx LLC00d7d5bf-ee03-e73d-e063-6394a90a5d942025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Elbow SleeveCAPSAICINNufabrx LLC27ef3ef0-2f98-6672-e063-6294a90aeca42025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Wrist SleeveCAPSAICINNufabrx LLC22572cf9-fc0c-d327-e063-6394a90a21862025-10-15WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWALGREENSeff77965-dc7f-49af-e053-2995a90a1a972025-10-14WarningsExact identifier
application number: M017
Pleasure Balm Kama SutraBENZOCAINECosmetic Enterprises Ltdf370e3c4-65ca-4f3c-a5aa-70e198e681a22025-10-14WarningsExact identifier
application number: M017
Vanicream HC Anti-ItchHYDROCORTISONEPharmaceutical Specialties, Inc.28b06507-27a5-2cb1-e054-00144ff8d46c2025-10-14WarningsExact identifier
application number: M017
TrilogelLIDOCAINE HYDROCHLORIDETrifluent Pharma LLC22af7d63-6a56-4a38-a95b-0f88410b23cb2025-10-14WarningsExact identifier
application number: M017
PROINNATE Numbing CreamMENTHOLGuangzhou Haishi Biological Technology Co., Ltd.40c63645-8ed3-82b3-e063-6294a90a52672025-10-13WarningsExact identifier
application number: M017
CramergesicMENTHOL, METHYL SALICYLATEThe Hygenic Company, LLCd0ffde7a-6942-74fc-e053-2a95a90a484a2025-10-13WarningsExact identifier
application number: M017
TricylateMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATETrifluent Pharma LLC4869b63a-e01e-4a79-a493-7a1b4d3e914b2025-10-13WarningsExact identifier
application number: M017
Doloflex Pain ReliefMENTHOL, METHYL SALICYLATEUnited Health & Beauty Corp32a830cc-04d3-102e-e063-6294a90a1cad2025-10-12WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINENanjing Anxing Medical Technology Co., Ltd.40c9b132-57ce-865e-e063-6394a90a20802025-10-10WarningsExact identifier
application number: M017
KinesysZINC OXIDEWilc Healthcare Inca32b44c3-eda0-48ea-95fc-250a2c2396ca2025-10-10WarningsExact identifier
application number: M017
Te-Fu Recovery MassageMENTHOL, METHYL SALICYLATEWasatch Product Development7bc2989f-dfb6-e8af-e053-2991aa0a0bf22025-10-10WarningsExact identifier
application number: M017
Anti-itchHYDROCORTISONEMedline Industries, LPb0947381-c0db-4253-ab40-3d45603ae65d2025-10-09WarningsExact identifier
application number: M017
Kalaya Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe2452c4b-2548-497f-828b-5d960402522a2025-10-08WarningsExact identifier
application number: M017
Kalaya Pain Relief 6X with ArnicaPAIN RELIEF CREAMAvaria Health & Beauty Corp60198d2e-4de3-3fa0-e053-2a91aa0afaf72025-10-08WarningsExact identifier
application number: M017
KALAYA PAIN RELIEF 6X WITH ARNICA - Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp9b9b7cad-a5e2-4445-856b-4aa439d77a802025-10-08WarningsExact identifier
application number: M017
KALAYA FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpd5021e6d-f29f-446b-874c-bdcabd9cf4f62025-10-08WarningsExact identifier
application number: M017
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe0c9f22a-165a-4558-ba3c-8592f1bd00162025-10-08WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-026-0185248002601120 g in 1 BOTTLE (85248-026-01) 120 g2026-01-30NoNoCurrent