FDA.reportPublic FDA data

DigestivEase

Manufacturer
Eight and Company L.L.C | King Bio Inc. | Apotheca Company
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:36:19

Label at a glance#

ProductDigestivEase
Active ingredientARSENIC TRIOXIDE, CALCIUM SULFATE ANHYDROUS, CARBO ANIMALIS, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, GOLDENSEAL, STRYCHNOS NUX-VOMICA SEED, ORNITHOGALUM UMBELLATUM WHOLE, RANCID BEEF, SILICON DIOXIDE
Label structure10 sections

Dosage and administration

Adults and children over 12: 2 sprays into the mouth each 30 minutes as needed for symptom relief the first day, 2 sprays 3 times a day thereafter. Under age 12 consult a health care professional.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Arsenicum alb 200C, Calc sulph 200C, Carbo an 12X, Carbo veg 12X, Cinchona 200C, Hydrastis 12X, Nox vomica 200C, Ornithogalum 12X, Pyrogenium 200, Silicea 12X.

PURPOSE:

OTC - PURPOSE SECTION

Temporarily relieves symptoms of gastric distress, including:

° nausea and food poisoning
° flatulence
° indigestion and heartburn
° stomach cramps

WARNINGS:

WARNINGS SECTION

Keep box for indications and other warnings.

If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12: 2 sprays into the mouth each 30 minutes as needed for symptom relief the first day, 2 sprays 3 times a day thereafter. Under age 12 consult a health care professional.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

Do not use if the transparent seal around spray bottle is broken or missing.

INDICATIONS:

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms of gastric distress, including:

° nausea and food poisoning

° flatulence

° indigestion and heartburn

° stomach cramps

° natural

° gluten & lactose free

° no artificial flavors or colors

° no known negative side effects

° no known negative drug interactions

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

 Non-GMO glycerin, organic alcohol 20% v/v, purified water.

QUESTIONS:

OTC - QUESTIONS SECTION

Mfd. for Eight and Company L.L.C.

Gaithersburg, MD 20879 1.800.377.5787

www.sprayology.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sprayology

DigestivEase

RELIEVES STOMACH DISTRESS

HOMEOPATHIC ORAL SPRAY

1.38 fl. oz (41 ml)

DigestivEase LBLDigestivEase LBL

DigestivEase CTNDigestivEase CTN

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130361096000511GTIN-13: 0361096000511
EAN-13: 0361096000511
GTIN-12: 361096000511
UPC-A: 361096000511
GTIN storage (14 digits): 00361096000511		ETCO0007 DigestivEase CTN.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61096-1005-12023-12-14C16284748780-1ba0f9c33-44f4-a910-e053-dadaa90a0b85DigestivEase
61096-1005-12023-01-30C16284748780-1ba0f9c33-44f4-a910-e053-dadaa90a0b85DigestivEase
61096-1005-12021-02-10C16284748780-1ba0f9c33-44f4-a910-e053-dadaa90a0b85DigestivEase
61096-1005-12021-01-29C16284748780-1ba0f9c33-44f4-a910-e053-dadaa90a0b85DigestivEase

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61096-1005-1DigestivEase41 mL in 1 BOTTLE, SPRAYLIQUID415
61096-1005-1DigestivEase1 in 1 CARTONLIQUID15

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61096-100561096-1005-1

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
ARSENIC TRIOXIDES7V92P67HOACTIB
CALCIUM SULFATE ANHYDROUSE934B3V59HACTIB
CARBO ANIMALIS279O8I0433ACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
GOLDENSEALZW3Z11D0JVACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
ORNITHOGALUM UMBELLATUM WHOLE9NS3M2Y78SACTIB
RANCID BEEF29SUH5R3HUACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
DigestivEaseARSENICUM ALB, CALC SULPH, CARBO AN, CARBO VEG, CINCHONA, HYDRASTIS, NOX VOM, ORNITHOGALUM, PYROGENIUM, SILICEAEight and Company L.L.C70840ff7-75c0-44a0-9eb8-b36f13518af22025-12-17WarningsExact identifier
ndc (package): 61096-1005-1
ndc (product): 61096-1005
ndc11 (package): 61096100501
spl id: 65b1cdb6-6730-408d-bea0-b2b7b43ee9a4
spl set id: 70840ff7-75c0-44a0-9eb8-b36f13518af2

Reported adverse events (FAERS/openFDA)#

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