Simplex

Product NDC
34666-008
11-digit product format
346660008
Labeler code
34666
Product ID
34666-008_47467544-a0d0-1d4e-e063-6394a90a1bb3
Type
HUMAN OTC DRUG
Nonproprietary name
Passiflora incarnata, Ignatia Amara, Valeriana Officinalis
Dosage form
TABLET
Route
ORAL
Labeler
Nartex Laboratories
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-12-23
Substance
PASSIFLORA INCARNATA FLOWER; STRYCHNOS IGNATII SEED; VALERIAN
Active strength
3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PASSIFLORA INCARNATA FLOWER3 [hp_X]/1
STRYCHNOS IGNATII SEED3 [hp_X]/1
VALERIAN3 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K8F3G29S6ZInternal UNII lookup
1NM3M2487KInternal UNII lookup
JWF5YAW3QWInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9047378-5d03-4ef5-98f9-3eb78840222cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34666-008-06Simplex6 in 1 BOXTABLET69
34666-008-60Simplex60 in 1 BOXTABLET609

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PASSIFLORA INCARNATA FLOWERACTIVE INGREDIENTK8F3G29S6ZSIMPLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIES]7
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487KSIMPLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIES]7
VALERIANACTIVE INGREDIENTJWF5YAW3QWSIMPLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIES]7
PASSIFLORA INCARNATA FLOWERACTIVE MOIETYK8F3G29S6ZSIMPLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIES]7
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487KSIMPLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIES]7
VALERIANACTIVE MOIETYJWF5YAW3QWSIMPLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIES]7
GELATININACTIVE INGREDIENT2G86QN327LSIMPLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIES]7
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSIMPLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIES]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMPLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIES]7
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSIMPLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIES]7
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TSIMPLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIES]7
TALCINACTIVE INGREDIENT7SEV7J4R1USIMPLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIES]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34666-008SIMPLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALIS) TABLET [NARTEX LABORATORIES]8Current NDC, Legacy NDC, 2 package rows20181228_d9047378-5d03-4ef5-98f9-3eb78840222c.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
SimplexPASSIFLORA INCARNATA, IGNATIA AMARA, VALERIANA OFFICINALISNartex Laboratoriesd9047378-5d03-4ef5-98f9-3eb78840222c2025-12-31WarningsExact identifier
ndc (product): 34666-008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34666-008-06346660008066 TABLET in 1 BOX (34666-008-06) 6 tablet2010-12-230000-00-00NoNoCurrent
34666-008-603466600086060 TABLET in 1 BOX (34666-008-60) 60 tablet2010-12-230000-00-00NoNoCurrent