Tension Headache

Product NDC
50845-0058
11-digit product format
508450058
Labeler code
50845
Product ID
50845-0058_02be9339-29af-4682-967d-f48e5ef34515
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
2014-06-02
Marketing end
2026-07-31
Substance
ACONITUM NAPELLUS; ARABICA COFFEE BEAN; DIOSCOREA VILLOSA TUBER; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; MILK THISTLE; PASSIFLORA INCARNATA FLOWERING TOP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; STELLARIA MEDIA; VERBASCUM THAPSUS
Active strength
200; 200; 3; 3; 3; 3; 2; 3; 3; 3 [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 NAPELLUS200 [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 OBTUSIFOLIUM3 [hp_X]/mL
STELLARIA MEDIA3 [hp_X]/mL
VERBASCUM THAPSUS3 [hp_X]/mL

Harmonized Identifiers#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0058-22024-07-31C16284748780-19d75b9d0-d4a1-f424-e053-dadaa90a57ceDrug Facts:
50845-0058-22024-01-30C16284748780-19d75b9d0-d4a1-f424-e053-dadaa90a57ceDrug Facts:
50845-0058-22021-12-16C16284748780-19d75b9d0-d4a1-f424-e053-dadaa90a57ceDrug Facts:
50845-0058-12020-01-31C16284748780-19d75b9d1-0c12-f424-e053-dadaa90a57ceDrug Facts
50845-0058-22020-01-31C16284748780-19d75b9d0-d4a1-f424-e053-dadaa90a57ceDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0058-1Tension Headache30 mL in 1 BOTTLE, SPRAYSPRAY308
50845-0058-2Tension Headache1 in 1 CARTONSPRAY18
50845-0058-1Tension Headache30 mL in 1 BOTTLE, SPRAYSPRAY303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0058TENSION 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.]8Current NDC, Legacy NDC, 2 package rows20240801_4ac40cd1-6f86-4183-a1ec-57e98bc01aa1.zip
50845-0058TENSION 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.]3Current NDC, Legacy NDC, 1 package rows20130522_96ccf3ee-af6d-43e2-9ec5-f19d1ff845f8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50845-0058-15084500580130 mL in 1 BOTTLE, SPRAY30 mlHistorical
50845-0058-2508450058021 BOTTLE, SPRAY in 1 CARTON (50845-0058-2) / 30 mL in 1 BOTTLE, SPRAY (50845-0058-1) 2014-06-022026-07-31NoNoCurrent