FDA.reportPublic FDA data

NDC 53499-3571-03 - Arnica Montana

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
53499-3571
Requested NDC
53499-3571-03
Package NDCs from labels
53499-3571-2, 53499-3571-3, 53499-3571-03
Manufacturer
Schwabe North America, Inc. | Schwabe Mexico, S.A. deC.V.
Effective date
2022-05-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Arnica Montana 30CSchwabe North America, Inc. | Schwabe Mexico, S.A. deC.V.2022-05-20HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-3571-2Arnica Montana100 in 1 BOTTLE, GLASSTABLET10011
53499-3571-3Arnica Montana250 in 1 BOTTLE, GLASSTABLET25011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-3571ARNICA MONTANA TABLET [SCHWABE NORTH AMERICA, INC.]11Current NDC, Legacy NDC, 2 package rows20220521_d96936e2-7356-4404-9617-8c61c87fb5d9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO]2
ARNICA MONTANAACTIVE MOIETYO80TY208ZWARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO]2

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 2 of 29 · 565 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERYNTH Muscle ComfortARNICA MONTANA HPUS 7% MUSCLE COMFORTJiangxi Yudexi Pharmaceutical Co., LTD4a4c10cd-f0c4-8731-e063-6394a90a10a52026-07-21WarningsExact identifier
unii: O80TY208ZW
REDCOOL Arnica BruiseARNICA MONTANA HPUS 7% ARNICA BRUISEJiangxi Zhongletang Pharmaceuticals Co.,Ltd.49911392-e55e-1a6b-e063-6394a90a9af02026-07-20WarningsExact identifier
unii: O80TY208ZW
Arnicare Leg CrampsARNICA MONTANA WHOLE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA TOP, CLAVICEPS PURPUREA SCLEROTIUMLaboratoires Boiron051a4e17-c665-ec4d-e063-6294a90aabe62026-07-20Exact identifier
unii: O80TY208ZW
ARNICAARNICA MONTANAHyland's Inc.85fcf1c8-6f89-4862-85a8-4983cbea28f42026-07-16WarningsExact identifier
unii: O80TY208ZW
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: O80TY208ZW
BM BM16 DROPSARNICA MONT, CACTUS GRAND, CRATAEGUS OXY, SPIGELIA, VALERIANABM Private Limited55b70ae1-e12c-df21-e063-6294a90a78d52026-07-03WarningsExact identifier
unii: O80TY208ZW
Leg CrampsACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOPHyland's Inc.fa0e82d1-0806-4256-82d2-8070336fbe1d2026-06-30WarningsExact identifier
unii: O80TY208ZW
Arnica Bruise CreamARNICA MONTANABeautivity LLC348f3161-8abf-26d7-e063-6294a90a41dc2026-06-29WarningsExact identifier
unii: O80TY208ZW
Hermon Arnica Cream sensitive skin formula 2 ozARNICA MONTANA 1X HPUSBeautivity LLC3f9d4d78-81fc-717f-e063-6394a90a5b8a2026-06-29WarningsExact identifier
unii: O80TY208ZW
Murasaki Beauty Arnica Bruise CreamARNICA MONTANA 1.5%Excelsior Commercial Inc4340b0d2-e350-59bf-e063-6394a90aaccb2026-06-29WarningsExact identifier
unii: O80TY208ZW
BM HAIR SUPPORT DROPSACID PHOS, ARNICA MONT, ARS. ALB., GRAPHITE, JABORANDI, LYCOPODIUM, PHOSPHORUS, SULPHURTotal Operations Management LLC DBA:Bestmade Natural Products Micro5460d96f-e2b1-51ff-e063-6294a90ac7822026-06-16WarningsExact identifier
unii: O80TY208ZW
BM BM27ARNICA MONT, CROCUS SAT., HAMAMELIS, MILLEFOLIUM, SANGUINARIA, SECALE CORN, TRILLIUM PENDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5448acb4-775a-3d22-e063-6394a90a98bf2026-06-15WarningsExact identifier
unii: O80TY208ZW
BM HAIR SUPPORT DROPSACID PHOS, ARNICA MONT, ARS. ALB., GRAPHITE, JABORANDI, LYCOPODIUM, PHOSPHORUS, SULPHURBM Private Limited544b1ad5-71ab-18e4-e063-6394a90a86352026-06-15WarningsExact identifier
unii: O80TY208ZW
KALMIAARNICA MONTANA, CHELIDONIUM, COLCHICUM, KALMIA, RANUNCULUS BULB, SANGUINARIA NIT, SUMBULTotal Operations Management LLC DBA:Bestmade Natural Products Micro54396b20-2708-1393-e063-6294a90ad8022026-06-14WarningsExact identifier
unii: O80TY208ZW
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: O80TY208ZW
NATUHEAL JOINT BACK PAIN RELIEFARNICA MONTANA HPUS 7% JOINT BACK PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4c923afa-4d1e-0776-e063-6294a90a2f542026-06-12WarningsExact identifier
unii: O80TY208ZW
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: O80TY208ZW
Arnica 20ARNICA 20Uriel Pharmacy, Inc2c90268b-b109-2f14-e063-6294a90a54bc2026-06-10WarningsExact identifier
unii: O80TY208ZW
Velloryn ARNICA BRUISE RELIEF CreamVELLORYN ARNICA BRUISE RELIEF CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd53f0f622-7021-56c2-e063-6294a90aea712026-06-10WarningsExact identifier
unii: O80TY208ZW
BM BM27ARNICA MONT, CROCUS SAT., HAMAMELIS, MILLEFOLIUM, SANGUINARIA, SECALE CORN, TRILLIUM PENDBM Private Limited53d4e5be-b144-4cbf-e063-6394a90aa6882026-06-09WarningsExact identifier
unii: O80TY208ZW

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.