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
ARABICA COFFEE BEAN200 [hp_C]/mL
DIOSCOREA VILLOSA TUBER3 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT3 [hp_X]/mL
IRIS VERSICOLOR ROOT3 [hp_X]/mL
MILK THISTLE3 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP2 [hp_X]/mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE3 [hp_X]/mL
STELLARIA MEDIA3 [hp_X]/mL
VERBASCUM THAPSUS WHOLE12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, 3SW678MX72, IWY3IWX2G8, 639KR60Q1Q, X43D4L3DQC, U946SH95EE, CLF5YFS11O, 36XQ854NWW, 2H03479QVR, C9TD27U172

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

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