Tension Headache

Product NDC
50845-0276
11-digit product format
508450276
Labeler code
50845
Product ID
50845-0276_f1dd093e-b729-4e5c-96da-6b0a2b0655f2
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum Napellus, Carduus Marianus, Coffea Cruda, Dioscorea Villosa, Gelsemium Sempervirens, Gnaphalium Polycephalum, Iris Versicolor, Passiflora Incarnata, Stellaria Media, Verbascum Thapsus
Dosage form
SPRAY
Route
ORAL
Labeler
Liddell Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-07-30
Marketing end
2027-11-21
Substance
ACONITUM NAPELLUS WHOLE; ARABICA COFFEE BEAN; DIOSCOREA VILLOSA TUBER; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; MILK THISTLE; PASSIFLORA INCARNATA FLOWERING TOP; PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE; STELLARIA MEDIA; VERBASCUM THAPSUS WHOLE
Active strength
200; 200; 3; 3; 3; 3; 2; 3; 3; 12 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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], Seed Storage Proteins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tension Headache

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS WHOLE200 [hp_C]/mL
MILK THISTLE200 [hp_C]/mL
ARABICA COFFEE BEAN3 [hp_X]/mL
DIOSCOREA VILLOSA TUBER3 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT3 [hp_X]/mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE3 [hp_X]/mL
IRIS VERSICOLOR ROOT2 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]/mL
STELLARIA MEDIA3 [hp_X]/mL
VERBASCUM THAPSUS WHOLE12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U0NQ8555JDInternal UNII lookup
U946SH95EEInternal UNII lookup
3SW678MX72Internal UNII lookup
IWY3IWX2G8Internal UNII lookup
639KR60Q1QInternal UNII lookup
36XQ854NWWInternal UNII lookup
X43D4L3DQCInternal UNII lookup
CLF5YFS11OInternal UNII lookup
2H03479QVRInternal UNII lookup
C9TD27U172Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6d49b251-bc9a-4383-a538-91d923e89148Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0276-1Tension Headache30 mL in 1 BOTTLE, SPRAYSPRAY302
50845-0276-2Tension Headache1 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0276TENSION HEADACHE (ACONITUM NAPELLUS, CARDUUS MARIANUS, COFFEA CRUDA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, PASSIFLORA INCARNATA, STELLARIA MEDIA, VERBASCUM THAPSUS) SPRAY [LIDDELL LABORATORIES, INC.]2Current NDC, 2 package rows20241105_6d49b251-bc9a-4383-a538-91d923e89148.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
Tension HeadacheACONITUM NAPELLUS, CARDUUS MARIANUS, COFFEA CRUDA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, PASSIFLORA INCARNATA, STELLARIA MEDIA, VERBASCUM THAPSUSLiddell Laboratories, Inc.6d49b251-bc9a-4383-a538-91d923e891482024-11-04WarningsExact identifier
ndc (product): 50845-0276

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50845-0276-15084502760130 mL in 1 BOTTLE, SPRAY30 mlHistorical
50845-0276-2508450276021 BOTTLE, SPRAY in 1 CARTON (50845-0276-2) / 30 mL in 1 BOTTLE, SPRAY (50845-0276-1) 2024-07-302027-11-21NoNoHistorical