FDA.reportPublic FDA data

Headache Relief

Manufacturer
Homeocare Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:36:43

Label at a glance#

ProductHeadache Relief
Active ingredientATROPA BELLADONNA, CYCLAMEN PURPURASCENS TUBER, COFFEA ARABICA SEED, ROASTED, IRIS VERSICOLOR ROOT, STRYCHNOS NUX-VOMICA SEED, SANGUINARIA CANADENSIS ROOT, SPIGELIA MARILANDICA ROOT, VIBURNUM OPULUS BARK
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Belladonna 8C, Cyclamen 8C, Coffea tosta 4C, Iris versicolor 8C, Nux vomica 9C, Sanguinaria 8C, Spigelia 8C, Viburnum opulus 4C.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Sucrose/lactose.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Purpose:

OTC - PURPOSE SECTION

Temporarily relieves migraines, tension and general headaches.

Warnings:

WARNINGS SECTION

If pregnant or nursing, or if symptoms persist, worsen or if fever, nausea or vomiting are present, consult a doctor promptly. Keep out of reach of children. Do not use if cap seal is broken or missing.

Indications & Usage:

INDICATIONS & USAGE SECTION

Turn turn upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

Dosage & Administration:

DOSAGE & ADMINISTRATION SECTION

Turn turn upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

Headache Relief

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hcl_label_headache 2012.jpghcl_label_headache 2012.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130361727305213GTIN-13: 0361727305213
EAN-13: 0361727305213
GTIN-12: 361727305213
UPC-A: 361727305213
GTIN storage (14 digits): 00361727305213		hcl_label_headache 2012.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61727-305-21Headache Relief4 g in 1 TUBEPELLET43

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
COFFEA ARABICA SEED, ROASTEDACTIVE INGREDIENT9H58JRT35E1
CYCLAMEN PURPURASCENS TUBERACTIVE INGREDIENTG728143D8Q1
IRIS VERSICOLOR ROOTACTIVE INGREDIENTX43D4L3DQC1
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD5081
SPIGELIA MARILANDICA ROOTACTIVE INGREDIENT467D26HS0B1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
VIBURNUM OPULUS BARKACTIVE INGREDIENTT1UG6H68051
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
COFFEA ARABICA SEED, ROASTEDACTIVE MOIETY9H58JRT35E1
CYCLAMEN PURPURASCENS TUBERACTIVE MOIETYG728143D8Q1
IRIS VERSICOLOR ROOTACTIVE MOIETYX43D4L3DQC1
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD5081
SPIGELIA MARILANDICA ROOTACTIVE MOIETY467D26HS0B1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
VIBURNUM OPULUS BARKACTIVE MOIETYT1UG6H68051
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1
SUCROSEINACTIVE INGREDIENTC151H8M5541

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61727-30561727-305-21

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
LACTOSEJ2B2A4N98GIACT
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CYCLAMEN PURPURASCENS TUBERG728143D8QACTIB
COFFEA ARABICA SEED, ROASTED9H58JRT35EACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
SPIGELIA MARILANDICA ROOT467D26HS0BACTIB
VIBURNUM OPULUS BARKT1UG6H6805ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCROSESUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii+route
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii+route
2 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / SUBLINGUAL352 mgExact identifier — unii+route
2 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / SUBLINGUAL352 mgExact identifier — unii+route
2 equally ranked IID candidates

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
Headache ReliefATROPA BELLADONNA, CYCLAMEN PURPURASCENS TUBER, COFFEA ARABICA SEED, ROASTED, IRIS VERSICOLOR ROOT, STRYCHNOS NUX-VOMICA SEED, SANGUINARIA CANADENSIS ROOT, SPIGELIA MARILANDICA ROOT, VIBURNUM OPULUS BARKHomeocare Laboratories47f7bcbc-f4be-4cf0-a5b0-b8d5ca8d852f2026-01-12WarningsExact identifier
ndc (package): 61727-305-21
ndc (product): 61727-305
ndc11 (package): 61727030521
spl id: 483751f9-ce23-d744-e063-6294a90a7b3f
spl set id: 47f7bcbc-f4be-4cf0-a5b0-b8d5ca8d852f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.