FDA.reportPublic FDA data

Cold and Flu Relief

Manufacturer
Eight and Company L.L.C | King Bio Inc. | Apotheca Company
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:36:23

Label at a glance#

ProductCold and Flu Relief
Active ingredientONION, ANTIMONY POTASSIUM TARTRATE, ARNICA MONTANA WHOLE, BAPTISIA TINCTORIA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, LACHESIS MUTA VENOM, MERCURIC IODIDE, LOBARIA PULMONARIA, SULFUR IODIDE, URTICA URENS WHOLE
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.Children under 12: consult a health care professional.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Allium cepa 30C, Antimon tart 200C, Arnica 4X, Baptisia 4X, Eupatorium perf 200C, Gelsemium 200C, Kali bic 200C, Lachesis 200C, Merc iod rub 200C, Sticta 200C, Sulphur iod 200C, Urtica ur 200C.

WARNINGS:

WARNINGS SECTION

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

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

INDICATIONS:

INDICATIONS & USAGE SECTION

Temporarily relieves the common symptoms of cold and flu, including:

  • sinus congestion
  • achiness
  • chills
  • headache and fever

º Natural

º Gluten & Lactose free

º No artificial flavors or colors

º Vegetarian

º No known negative side effects

º No known negative drug interactions

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.Children under 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.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

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

PURPOSE:

OTC - PURPOSE SECTION

Temporarily relieves the common symptoms of cold and flu, including:

  • sinus congestion
  • achiness
  • chills
  • headache and fever

º Natural

º Gluten & Lactose free

º No artificial flavors or colors

º Vegetarian

º No known negative side effects

º No known negative drug interactions

QUESTIONS:

OTC - QUESTIONS SECTION

Manufactured 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

NDC 61096-1002-1

sprayology

Cold + Flu Relief

BATTLES THE

DISCOMFORT OF

COLDS AND FLU

HOMEOPATHIC ORAL SPRAY

1.38 fl.oz (41 ml)

Cold + Flu Relief LBLCold + Flu Relief LBL

Cold + Flu Relief CNTCold + Flu Relief CNT

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130361096000214GTIN-13: 0361096000214
EAN-13: 0361096000214
GTIN-12: 361096000214
UPC-A: 361096000214
GTIN storage (14 digits): 00361096000214		ETCO0017 Cold + Flu Relief CTN.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61096-1002-12023-09-15C16284748780-1f386c649-d5d3-0266-e053-dadaa90a7c1aCold and Flu Relief
61096-1002-12023-01-30C16284748780-1f386c649-d5d3-0266-e053-dadaa90a7c1aCold and Flu Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61096-1002-1Cold and Flu Relief41 mL in 1 BOTTLE, SPRAYLIQUID417
61096-1002-1Cold and Flu Relief1 in 1 CARTONLIQUID17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANTIMONY POTASSIUM TARTRATEACTIVE INGREDIENTDL6OZ476V31
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
BAPTISIA TINCTORIA ROOTACTIVE INGREDIENT5EF0HWI5WU1
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE INGREDIENT1W0775VX6E1
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q1
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07I1
LOBARIA PULMONARIAACTIVE INGREDIENTD1YM0P5Z2T1
MERCURIC IODIDEACTIVE INGREDIENTR03O05RB0P1
ONIONACTIVE INGREDIENT492225Q21H1
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FM1
SULFUR IODIDEACTIVE INGREDIENTL6L8KA2AA01
URTICA URENSACTIVE INGREDIENTIHN2NQ5OF91
ANTIMONY CATION (3+)ACTIVE MOIETY069647RPT51
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
BAPTISIA TINCTORIA ROOTACTIVE MOIETY5EF0HWI5WU1
DICHROMATE IONACTIVE MOIETY9LKY4BFN2V1
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE MOIETY1W0775VX6E1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q1
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07I1
LOBARIA PULMONARIAACTIVE MOIETYD1YM0P5Z2T1
MERCURIC IODIDEACTIVE MOIETYR03O05RB0P1
ONIONACTIVE MOIETY492225Q21H1
SULFUR IODIDEACTIVE MOIETYL6L8KA2AA01
URTICA URENSACTIVE MOIETYIHN2NQ5OF91
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61096-100261096-1002-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ONION492225Q21HACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
ARNICA MONTANA WHOLEO80TY208ZWACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
MERCURIC IODIDER03O05RB0PACTIB
LOBARIA PULMONARIAD1YM0P5Z2TACTIB
SULFUR IODIDEL6L8KA2AA0ACTIB
URTICA URENS WHOLEIHN2NQ5OF9ACTIB
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Cold and Flu ReliefALLIUM CEPA, ANTIMON TART, ARNICA, BAPTISIA, EUPATORIUM PERF, GELSEMIUM, KALI BIC, LACHESIS, MER IOD RUB, STICTA , SULPHUR IOD, URTICA UREight and Company L.L.C9c5fa3e0-3e99-4fe0-86b9-f4d8de230a982025-12-22WarningsExact identifier
ndc (package): 61096-1002-1
ndc (product): 61096-1002
ndc11 (package): 61096100201
spl id: c83cc058-3fbb-4b21-9995-62a5572b90c6
spl set id: 9c5fa3e0-3e99-4fe0-86b9-f4d8de230a98

Reported adverse events (FAERS/openFDA)#

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