FDA.reportPublic FDA data

Simply Harmony

Product NDC
34666-403
11-digit product format
346660403
Labeler code
34666
Product ID
34666-403_d244bc14-51d3-2c4c-e053-2995a90a63a9
Type
HUMAN OTC DRUG
Nonproprietary name
Ignatia amara, Passiflora incarnata, Valeriana officinalis, Kali phosphoricum
Dosage form
TABLET
Route
ORAL
Labeler
Nartex Laboratorios Homeopaticos, S.A. De C.V.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-12-03
Substance
DIBASIC POTASSIUM PHOSPHATE; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS IGNATII SEED; VALERIAN
Active strength
6; 3; 3; 3 [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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]/1
VALERIAN3 [hp_X]/1
DIBASIC POTASSIUM PHOSPHATE3 [hp_X]/1
STRYCHNOS IGNATII SEED3 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CLF5YFS11OInternal UNII lookup
JWF5YAW3QWInternal UNII lookup
CI71S98N1ZInternal UNII lookup
1NM3M2487KInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d244bc14-51d2-2c4c-e053-2995a90a63a9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34666-403-01Simply Harmony120 in 1 BOTTLETABLET1201
34666-403-01Simply Harmony1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34666-403SIMPLY HARMONY (IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, KALI PHOSPHORICUM) TABLET [NARTEX LABORATORIOS HOMEOPATICOS, S.A. DE C.V.]1Current NDC, Legacy NDC, 2 package rows20211216_d244bc14-51d2-2c4c-e053-2995a90a63a9.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
Simply HarmonyIGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, KALI PHOSPHORICUMNartex Laboratorios Homeopaticos, S.A. De C.V.d244bc14-51d2-2c4c-e053-2995a90a63a92021-12-03WarningsExact identifier
ndc (product): 34666-403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34666-403-01346660403011 BOTTLE in 1 CARTON (34666-403-01) / 120 TABLET in 1 BOTTLE1 bottle2021-12-030000-00-00NoNoCurrent