FDA.reportPublic FDA data

Orostat Solution

Manufacturer
Gingi-Pak a Division of the Belport | Jeff Nichols
Effective date
2026-06-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-07-17 21:36:21

Label at a glance#

ProductOrostat 8%
Active ingredientEPINEPHRINE HYDROCHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive Ingredient

Purpose

OTC - PURPOSE SECTION

PurposePurpose

Description

DESCRIPTION SECTION

DescriptionDescription

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Keep out of reach if children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach if childrenKeep out of reach if children

Storage

STORAGE AND HANDLING SECTION

StorageStorage

Uses

INDICATIONS & USAGE SECTION

UsesUses

Do not use

OTC - STOP USE SECTION

Do not useDo not use

Warnings

WARNINGS SECTION

WarningsWarnings

Directions

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

Principal Display-Orostat 8%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display-Orostat 8%Principal Display-Orostat 8%

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10129-006-022025-01-30C16284748780-1c7ccaba7-2457-fd44-e053-dadaa90aa01bOrostat Solution
10129-006-022025-01-30C16284748780-1c7ccaba7-2457-fd44-e053-dadaa90aa01bOrostat Solution
10129-006-022021-09-02C16284748780-1c7ccaba7-2457-fd44-e053-dadaa90aa01bOrostat Solution
10129-006-022021-09-02C16284748780-1c7ccaba7-2457-fd44-e053-dadaa90aa01bOrostat Solution
10129-006-022021-07-23C16284748780-1c7ccaba7-2457-fd44-e053-dadaa90aa01bOrostat Solution
10129-006-022021-07-23C16284748780-1c7ccaba7-2457-fd44-e053-dadaa90aa01bOrostat Solution

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10129-00610129-006-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETIC ACID9G34HU7RV0IACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM DITHIONITE2K5B8F6ES1IACT
SODIUM THIOSULFATEHX1032V43MIACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
PROPYLPARABENZ8IX2SC1OHIACT
BENZYL ALCOHOLLKG8494WBHIACT
EPINEPHRINE HYDROCHLORIDEWBB047OO38ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12018-01-11full-release2026-05-31 22:56:48

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
Orostat 8%EPINEPHRINE HYDROCHLORIDEGingi-Pak a Division of the Belport755005b8-165b-b667-e053-2991aa0a36512026-06-26WarningsExact identifier
ndc (package): 10129-006-02
ndc (product): 10129-006
ndc11 (package): 10129000602
spl id: 552f7c53-4da9-8ebd-e063-6394a90a5632
spl set id: 755005b8-165b-b667-e053-2991aa0a3651

Reported adverse events (FAERS/openFDA)#

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