FDA.reportPublic FDA data

HEADACHE HP

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2025-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:35:46

Label at a glance#

ProductHEADACHE HP
Active ingredientSILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIA
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*): Argentum Nitricum 30C, Belladonna 30C, Bryonia Alba 30C, Gelsemium Sempervirens 30C, Glonoinum 30C, Lachesis Mutus 30C, Lycopodium Clavatum 30C, Melilotus Officinalis 30C, Natrum Muriaticum 30C, Nux Vomica 30C, Silicea 30C, Spigelia Anthelmia 30C

INDICATIONS & USAGE SECTION

USES: Temporarily relieves symptoms due to tension and pressure of the head, headache.**

WARNINGS SECTION

WARNING:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. 
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • DO not use if TAMPER EVIDENT seal is broken or missing.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

REFERENCES SECTION

*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Purified Water, USP Ethyl Alcohol

OTC - QUESTIONS SECTION

QUESTIONS AND COMMENTS?

Natural Creations / Woodbine, IA / 51579 / 712-647-1600

OTC - PURPOSE SECTION

USES: Temporarily relieves symptoms due to tension and pressure of the head, headache.**

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0025-1

HEADACHE HP

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Image Of LabelImage Of Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130877730001535GTIN-13: 0877730001535
EAN-13: 0877730001535
GTIN-12: 877730001535
UPC-A: 877730001535
GTIN storage (14 digits): 00877730001535		HEADACHE HP.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
00358076-c817-430b-b924-11d717dc307cProduct name120160718
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0025-12023-01-19C16284748780-19855d018-da1e-cd31-e053-dbdaa90ab51aHEADACHE HP
43406-0025-12019-11-27C16284748780-19855d018-da1e-cd31-e053-dbdaa90ab51aHEADACHE HP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0025-1HEADACHE HP30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B1
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07I1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
MELILOTUS OFFICINALIS TOPACTIVE INGREDIENTGM6P02J2DX1
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS31
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
SILVER NITRATEACTIVE INGREDIENT95IT3W8JZE1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X1
SPIGELIA ANTHELMIAACTIVE INGREDIENTWYT05213GE1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B1
CHLORIDE IONACTIVE MOIETYQ32ZN486981
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07I1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
MELILOTUS OFFICINALIS TOPACTIVE MOIETYGM6P02J2DX1
NITROGLYCERINACTIVE MOIETYG59M7S0WS31
SILVER CATIONACTIVE MOIETY57N7B0K90A1
SPIGELIA ANTHELMIAACTIVE MOIETYWYT05213GE1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-002543406-0025-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILVER NITRATE95IT3W8JZEACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
NITROGLYCERING59M7S0WS3ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MELILOTUS OFFICINALIS TOPGM6P02J2DXACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SPIGELIA ANTHELMIAWYT05213GEACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
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 HPSILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIANatural Creations, Inc.c38b83f0-3918-4ef6-8dfd-48fe438e584a2025-12-12WarningsExact identifier
ndc (package): 43406-0025-1
ndc (product): 43406-0025
ndc11 (package): 43406002501
spl id: f44b45b5-cfa8-4d2d-a530-f973032c08d1
spl set id: c38b83f0-3918-4ef6-8dfd-48fe438e584a

Reported adverse events (FAERS/openFDA)#

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