FDA.reportPublic FDA data

Opsin I

Manufacturer
Professional Complementary Health Formulas | Natural Pharmaceutical Manufacturing LLC
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:49:42

Label at a glance#

ProductOpsin I 6014
Active ingredientEPINEPHRINE, SILVER NITRATE, ARSENIC TRIOXIDE, ACTIVATED CHARCOAL, HYDRANGEA ARBORESCENS ROOT, LIQUID PETROLEUM, ACETALDEHYDE, COUMARIN, GALLIC ACID MONOHYDRATE, HISTAMINE DIHYDROCHLORIDE, INDOLE-3-CARBINOL, YEAST MANNAN, RUTIN, DEOXYMUTAASPERGILLIC ACID
Label structure9 sections

Dosage and administration

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Adrenalinum 6X
Argentum nitricum 6X
Arsenicum album 6X
Carbo vegetabilis 6X
Hydrangea arborescens 6X
Petroleum 6X
Acetaldehyde 12X
Coumarinum 12X
Gallicum acidum 12X
Histaminum hydrochloricum 12X
Indolum 12X
Mannan 12X
Rutin 12X
Aflatoxin 30X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

For the temporary relief of gas, bloating, diarrhea, runny nose, sneezing, itching of the nose or throat, and itchy or watery eyes due to sensitivity to food allergens or autotoxins.*

OTC - PURPOSE SECTION

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

WARNINGS

WARNINGS SECTION

In case of overdose, get medical help or contact a poison control center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare professional before use.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

20% ethanol, purified water.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Est 1985

Professional Formulas

Complementary Health

Opsin I

Homeopathic Remedy

2 FL. OZ. (59 mL)

Label imageLabel image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-6014-22026-01-09C16284748780-11030e365-1701-111a-e063-dadaa90a10e2X14
63083-6014-22026-01-09C16284748780-11030e365-1701-111a-e063-dadaa90a10e2X14
63083-6014-22024-01-30C16284748780-11030e365-1701-111a-e063-dadaa90a10e2X14
63083-6014-22024-01-30C16284748780-11030e365-1701-111a-e063-dadaa90a10e2X14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-6014-2Opsin I601459 mL in 1 BOTTLE, DROPPERLIQUID592

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63083-601463083-6014-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
EPINEPHRINEYKH834O4BHACTIB
SILVER NITRATE95IT3W8JZEACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
HYDRANGEA ARBORESCENS ROOTSFK828Q2DEACTIB
LIQUID PETROLEUM6ZAE7X688JACTIB
ACETALDEHYDEGO1N1ZPR3BACTIB
COUMARINA4VZ22K1WTACTIB
GALLIC ACID MONOHYDRATE48339473OTACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
INDOLE-3-CARBINOLC11E72455FACTIB
YEAST MANNAN91R887N59PACTIB
RUTIN5G06TVY3R7ACTIB
DEOXYMUTAASPERGILLIC ACID0C9LJ2USYBACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12019-08-15full-release2026-06-01 02:17:17

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
Opsin I 6014OPSIN IProfessional Complementary Health Formulasac4185b4-7b9b-4608-9157-d8be86582ff82026-01-08WarningsExact identifier
ndc (package): 63083-6014-2
ndc (product): 63083-6014
ndc11 (package): 63083601402
spl id: bca11e36-d24b-43e5-bded-e202480df00f
spl set id: ac4185b4-7b9b-4608-9157-d8be86582ff8

Reported adverse events (FAERS/openFDA)#

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