DEMYC

Product NDC
59469-306
11-digit product format
594690306
Labeler code
59469
Product ID
59469-306_28ef7cc8-b305-4431-b400-3625a6213d3a
Type
HUMAN OTC DRUG
Nonproprietary name
RANUNCULUS BULBOSUS, Delphinium staphisagria Seed, MACROPIPER METHYSTICUM ROOT, Anagallis arvensis, Calendula officinalis Flowering Top, and SAGE
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-24
Substance
RANUNCULUS BULBOSUS WHOLE; DELPHINIUM STAPHISAGRIA SEED; PIPER METHYSTICUM ROOT; LYSIMACHIA ARVENSIS WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; SAGE
Active strength
5; 6; 8; 237; 806; 774 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
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
DEMYC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANUNCULUS BULBOSUS WHOLE5 [hp_X]/20mL
DELPHINIUM STAPHISAGRIA SEED6 [hp_X]/20mL
PIPER METHYSTICUM ROOT8 [hp_X]/20mL
LYSIMACHIA ARVENSIS WHOLE237 mg/20mL
CALENDULA OFFICINALIS FLOWERING TOP806 mg/20mL
SAGE774 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AEQ8NXJ0MBInternal UNII lookup
00543AP1JVInternal UNII lookup
BOW48C81XPInternal UNII lookup
46883LR90EInternal UNII lookup
18E7415PXQInternal UNII lookup
065C5D077JInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03b8001a-9910-4ce8-92ac-fabe4f9a0002Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-306-20DEMYC1 in 1 BOXSOLUTION/ DROPS12
59469-306-20DEMYC20 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-306DEMYC (RANUNCULUS BULBOSUS, DELPHINIUM STAPHISAGRIA SEED, MACROPIPER METHYSTICUM ROOT, ANAGALLIS ARVENSIS, CALENDULA OFFICINALIS FLOWERING TOP, AND SAGE) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]2Current NDC, Legacy NDC, 2 package rows20230113_03b8001a-9910-4ce8-92ac-fabe4f9a0002.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
DEMYCRANUNCULUS BULBOSUS, DELPHINIUM STAPHISAGRIA SEED, MACROPIPER METHYSTICUM ROOT, ANAGALLIS ARVENSIS, CALENDULA OFFICINALIS FLOWERING TOP, AND SAGEPEKANA Naturheilmittel GmbH03b8001a-9910-4ce8-92ac-fabe4f9a00022023-01-11WarningsExact identifier
ndc (product): 59469-306

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-306-20594690306201 BOTTLE, GLASS in 1 BOX (59469-306-20) / 20 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent