FDA.reportPublic FDA data

SEPIA PLEX

Product NDC
62106-0117
11-digit product format
621060117
Labeler code
62106
Product ID
62106-0117_c72dc8a8-5a42-fb8c-e053-2a95a90a9e5f
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum napellus, Cimicifuga racemosa, Lachesis mutus, Melissa officinalis, Platinum metallicum, Sanguinaria canadensis, Sepia, Sulphuricum acidum, Valeriana officinalis
Dosage form
LIQUID
Route
ORAL
Labeler
Seroyal USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-04-03
Substance
ACONITUM NAPELLUS; BLACK COHOSH; LACHESIS MUTA VENOM; MELISSA OFFICINALIS; PLATINUM; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFURIC ACID; VALERIAN
Active strength
6; 3; 8; 2; 8; 3; 3; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SEPIA PLEX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BLACK COHOSH6 [hp_X]/30mL
LACHESIS MUTA VENOM3 [hp_X]/30mL
PLATINUM8 [hp_X]/30mL
SANGUINARIA CANADENSIS ROOT2 [hp_X]/30mL
SEPIA OFFICINALIS JUICE8 [hp_X]/30mL
MELISSA OFFICINALIS3 [hp_X]/30mL
SULFURIC ACID3 [hp_X]/30mL
VALERIAN6 [hp_X]/30mL
ACONITUM NAPELLUS6 [hp_X]/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K73E24S6X9Internal UNII lookup
VSW71SS07IInternal UNII lookup
49DFR088MYInternal UNII lookup
N9288CD508Internal UNII lookup
QDL83WN8C2Internal UNII lookup
YF70189L0NInternal UNII lookup
O40UQP6WCFInternal UNII lookup
JWF5YAW3QWInternal UNII lookup
U0NQ8555JDInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c4a0a95-3848-4e19-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-0117-0SEPIA PLEX30 mL in 1 BOTTLE, GLASSLIQUID304
62106-0117-0SEPIA PLEX1 in 1 CARTONLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-0117SEPIA PLEX (ACONITUM NAPELLUS, CIMICIFUGA RACEMOSA, LACHESIS MUTUS, MELISSA OFFICINALIS, PLATINUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA, SULPHURICUM ACIDUM, VALERIANA OFFICINALIS) LIQUID [SEROYAL USA]4Current NDC, Legacy NDC, 2 package rows20210716_4c4a0a95-3848-4e19-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
SEPIA PLEXACONITUM NAPELLUS, CIMICIFUGA RACEMOSA, LACHESIS MUTUS, MELISSA OFFICINALIS, PLATINUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA, SULPHURICUM ACIDUM, VALERIANA OFFICINALISSeroyal USA4c4a0a95-3848-4e19-e054-00144ff8d46c2021-07-15WarningsExact identifier
ndc (product): 62106-0117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62106-0117-0621060117001 BOTTLE, GLASS in 1 CARTON (62106-0117-0) / 30 mL in 1 BOTTLE, GLASS2017-04-030000-00-00NoNoCurrent