FDA.reportPublic FDA data

Headache Relief

Product NDC
54973-4008
11-digit product format
549734008
Labeler code
54973
Product ID
54973-4008_efa50f1b-2f79-510f-e053-2a95a90ad548
Type
HUMAN OTC DRUG
Nonproprietary name
Atropa Belladonna, Gelsemium Sempervirens Root, Ipecac and Iris Versicolor Root
Dosage form
TABLET
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-04-03
Substance
ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT
Active strength
12; 6; 6; 6 [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
Headache Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPA BELLADONNA12 [hp_X]/1
GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]/1
IPECAC6 [hp_X]/1
IRIS VERSICOLOR ROOT6 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWQZ3G9PF0H, 639KR60Q1Q, 62I3C8233L, X43D4L3DQC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4008-1Headache Relief1 in 1 CARTONTABLET12
54973-4008-1Headache Relief100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4008HEADACHE RELIEF (ATROPA BELLADONNA, GELSEMIUM SEMPERVIRENS ROOT, IPECAC AND IRIS VERSICOLOR ROOT) TABLET [HYLAND'S INC.]2Current NDC, Legacy NDC, 2 package rows20221213_a58f376e-90ed-d5f5-e053-2a95a90a0442.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-4008-1549734008011 BOTTLE in 1 CARTON (54973-4008-1) / 100 TABLET in 1 BOTTLE1 bottle2020-04-030000-00-00NoNoCurrent