FDA.reportPublic FDA data

FEBRIPLEX

Product NDC
62106-9911
11-digit product format
621069911
Labeler code
62106
Product ID
62106-9911_eceb2ab1-7e67-dd8c-e053-2a95a90aa848
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum napellus, Arnica montana, Belladonna, Eupatorium perfoliatum, Gelsemium sempervirens, Mercurius solubilis, Rhus toxicodendron
Dosage form
TABLET
Route
ORAL
Labeler
Seroyal USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-06-26
Substance
ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; MERCURIUS SOLUBILIS; TOXICODENDRON PUBESCENS SHOOT
Active strength
6; 8; 8; 10; 12; 10; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
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
FEBRIPLEX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS6 [hp_X]/1
ARNICA MONTANA ROOT8 [hp_X]/1
ATROPA BELLADONNA8 [hp_X]/1
EUPATORIUM PERFOLIATUM FLOWERING TOP10 [hp_X]/1
GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]/1
MERCURIUS SOLUBILIS10 [hp_X]/1
TOXICODENDRON PUBESCENS SHOOT8 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U0NQ8555JDInternal UNII lookup
MUE8Y11327Internal UNII lookup
WQZ3G9PF0HInternal UNII lookup
1W0775VX6EInternal UNII lookup
639KR60Q1QInternal UNII lookup
324Y4038G2Internal UNII lookup
46PYZ1F82MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
52e1f6ff-f4b9-693a-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-9911-3FEBRIPLEX1 in 1 BOXTABLET14
62106-9911-3FEBRIPLEX30 in 1 BLISTER PACKTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-9911FEBRIPLEX (ACONITUM NAPELLUS, ARNICA MONTANA, BELLADONNA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, MERCURIUS SOLUBILIS, RHUS TOXICODENDRON) TABLET [SEROYAL USA]4Current NDC, Legacy NDC, 2 package rows20221108_52e1f6ff-f4b9-693a-e054-00144ff8d46c.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FEBRIPLEXACONITUM NAPELLUS, ARNICA MONTANA, BELLADONNA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, MERCURIUS SOLUBILIS, RHUS TOXICODENDRONSeroyal USA52e1f6ff-f4b9-693a-e054-00144ff8d46c2022-11-07WarningsExact identifier
ndc (product): 62106-9911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62106-9911-3621069911031 BLISTER PACK in 1 BOX (62106-9911-3) / 30 TABLET in 1 BLISTER PACK1 blister pack2017-06-260000-00-00NoNoCurrent