FDA.reportPublic FDA data

SWELLING HP

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2022-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:19:27

Label at a glance#

ProductSWELLING HP
Active ingredientAPIS MELLIFERA, ARSENIC TRIOXIDE, CINCHONA OFFICINALIS BARK, DIGITALIS, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, TOXICODENDRON PUBESCENS LEAF, SAMBUCUS NIGRA FLOWERING TOP, STROPHANTHUS HISPIDUS SEED
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Apis Mellifica 30C, Arsenicum Album 30C, Cinchona Officinalis 30C, Digitalis Purpurea 30C, Lachesis Mutus 30C, Lycopodium Clavatum 30C, Natrum Sulphuricum 30C, Rhus Toxicodendron 30C, Sambucus Nigra 30C, Strophanthus Hispidus 30C

INDICATIONS & USAGE SECTION

USES: Temporarily relieves sensation of soreness & swelling of hands & feet.**

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: Ethyl Acohol USP, Purified Water.

OTC - QUESTIONS SECTION

QUESTIONS AND COMMENTS?

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

OTC - PURPOSE SECTION

USES: Temporarily relieves sensation of soreness & swelling of hands & feet.**

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: 43406-0627-1

SWELLING HP

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

UPC: 877730004598 NON GMO Logo

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0627-12023-01-10C16284748780-19d75b9d1-27c0-f424-e053-dadaa90a57ceSWELLING HP
43406-0627-12022-01-28C16284748780-19d75b9d1-27c0-f424-e053-dadaa90a57ceSWELLING HP
43406-0627-12020-09-11C16284748780-19d75b9d1-27c0-f424-e053-dadaa90a57ceSWELLING HP
43406-0627-12020-01-31C16284748780-19d75b9d1-27c0-f424-e053-dadaa90a57ceSWELLING HP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0627-1SWELLING HP30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0627SWELLING HP (APIS MELLIFERA, ARSENIC TRIOXIDE, CINCHONA OFFICINALIS BARK, DIGITALIS, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, TOXICODENDRON PUBESCENS LEAF, SAMBUCUS NIGRA FLOWERING TOP, STROPHANTHUS HISPIDUS SEED) LIQUID [NATURAL CREATIONS, INC.]3Current NDC, Legacy NDC, 1 package rows20230111_88e50673-d47a-49f8-8be9-253f8b735c4e.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-062743406-0627-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
DIGITALISF1T8QT9U8BACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM SULFATE0YPR65R21JACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
STROPHANTHUS HISPIDUS SEEDMO892VI77KACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
SWELLING HPAPIS MELLIFERA, ARSENIC TRIOXIDE, CINCHONA OFFICINALIS BARK, DIGITALIS, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, TOXICODENDRON PUBESCENS LEAF, SAMBUCUS NIGRA FLOWERING TOP, STROPHANTHUS HISPIDUS SEEDNatural Creations, Inc.88e50673-d47a-49f8-8be9-253f8b735c4e2022-12-19WarningsExact identifier
ndc (package): 43406-0627-1
ndc (product): 43406-0627
ndc11 (package): 43406062701
spl id: 92875cfb-2144-4616-9bbb-13cfa639f95a
spl set id: 88e50673-d47a-49f8-8be9-253f8b735c4e

Reported adverse events (FAERS/openFDA)#

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