FDA.reportPublic FDA data

Hypericum perforatum

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-02-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:12:17

Label at a glance#

ProductHypericum perforatum
Active ingredientHYPERICUM PERFORATUM
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Nerve pain and injury; Puncture wounds; Depression; Neuralgia.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth, (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Hypericum perforatum 30c.

OTC - PURPOSE SECTION

Nerve pain and injury; Puncture wounds; Depression; Neuralgia.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-9010-12022-01-28C16284748780-1d6a99b39-edee-a426-e053-dadaa90af4c2Hypericum 9010P

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-9010-1Hypericum perforatum28 g in 1 BOTTLE, GLASSPELLET281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-9010HYPERICUM PERFORATUM PELLET [NEWTON LABORATORIES, INC.]1Legacy NDC, 1 package rows20200213_9e64b6c1-99a4-4928-e053-2995a90a65fa.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-901055714-9010-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
HYPERICUM PERFORATUMXK4IUX8MNBACTIB

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hypericum perforatumHYPERICUM PERFORATUMBoiron85ca53d0-c6d0-ef96-e053-2991aa0a7c342026-01-02Name fallback
brand name: Hypericum perforatum
Hypericum perforatumHYPERICUM PERFORATUMBoiron85cab607-c6d7-c28e-e053-2a91aa0adf572026-01-02Name fallback
brand name: Hypericum perforatum
Hypericum perforatumHYPERICUM PERFORATUMBoiron85cab607-c6b6-c28e-e053-2a91aa0adf572026-01-02Name fallback
brand name: Hypericum perforatum
Hypericum perforatumHYPERICUM PERFORATUMBoiron85caf69a-43ca-816c-e053-2991aa0ac94c2026-01-02Name fallback
brand name: Hypericum perforatum
Hypericum perforatumHYPERICUM PERFORATUMBoiron85c9cdf2-d35d-47cb-e053-2991aa0ab00b2026-01-02Name fallback
brand name: Hypericum perforatum
Hypericum perforatumHYPERICUM PERFORATUMBoiron85ca037f-971a-2224-e053-2991aa0a0d3e2026-01-02Name fallback
brand name: Hypericum perforatum
Hypericum perforatumHYPERICUM PERFORATUMBoiron7c39a6a0-7b72-11e6-b1b9-424c583030312026-01-02Name fallback
brand name: Hypericum perforatum
Hypericum perforatumHYPERICUM PERFORATUMBoiron85c9ff86-a62a-1115-e053-2991aa0a580c2026-01-02Name fallback
brand name: Hypericum perforatum
Hypericum perforatumHYPERICUM PERFORATUMBoiron85ca8916-5b04-132e-e053-2a91aa0ac56d2025-12-30WarningsName fallback
brand name: Hypericum perforatum
Hypericum perforatumHYPERICUM PERFORATUMBoiron85cad8e2-1332-9897-e053-2a91aa0abd1e2025-12-30Name fallback
brand name: Hypericum perforatum
Hypericum perforatumHYPERICUM PERFORATUMBoiron85c9ffa3-a7fa-213e-e053-2a91aa0ae9d22025-12-30Name fallback
brand name: Hypericum perforatum
Hypericum perforatumHYPERICUM PERFORATUMBoiron85cad8e2-1341-9897-e053-2a91aa0abd1e2025-12-30Name fallback
brand name: Hypericum perforatum
A-5SUCROSEDNA Labs, Inc.8e63f697-26c1-4518-acd3-5ea72cfa27f72025-01-09WarningsName fallback
generic name: SUCROSE
Saccharum officinaleSUCROSEBoiron86d04552-b31a-0fcf-e053-2991aa0acecd2023-11-14Name fallback
generic name: SUCROSE
Saccharum officinaleSUCROSEBoiron86d05561-6f09-6f1f-e053-2a91aa0a4b982023-11-14Name fallback
generic name: SUCROSE
Saccharum officinaleSUCROSEBoiron6858f374-8549-4b00-e053-2991aa0a5c3c2023-02-20Name fallback
generic name: SUCROSE
Hypericum PerforatumHYPERICUM PERFORATUMHahnemann Laboratories, INC.eab7d9fd-0df7-c9de-e053-2a95a90ad67b2022-10-10Name fallback
brand name: Hypericum Perforatum
HYPERICUM PERFORATUMHYPERICUM PERFORATUMRxhomeo Private Limited d.b.a. Rxhomeo, Inc1241b306-e37f-4381-9e7c-1861d1c5dae12021-09-02WarningsName fallback
brand name: HYPERICUM PERFORATUM

Reported adverse events (FAERS/openFDA)#

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