Throat Spray

Manufacturer
Natural Creations, Inc | OHM Pharma, Inc
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:19:31

Label at a glance#

ProductThroat
Active ingredientBAPTISIA TINCTORIA WHOLE, PHYTOLACCA AMERICANA ROOT, GOLDENSEAL, APIS MELLIFERA, SILVER NITRATE, ATROPA BELLADONNA, CALCIUM SULFIDE, POTASSIUM DICHROMATE, CANIS LUPUS FAMILIARIS MILK, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Baptisia 4X, Phytolacca 4X, Hydrastis 6X, Apis mel 12X, Arg Nit 12X, Belladonna 12X, Hepar Sulph Calc 12X, Kali Bic 12X, Lac Can 12X, Lachesis 12X, Merc Solub 12X

INDICATIONS & USAGE SECTION

USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**

OTC - PURPOSE SECTION

USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Spray 3 to 5 times towards back of the throat as needed or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Clove Bud, Ethyl Alcohol USP, Glycerin USP, Marshmallow Root, Menthol Crystals, Myrrh Gum, Purified Water, Sage leaves, Thyme Leaves, Yellow Dock Root

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:43406-0669-2

Throat Spray

HOMEOPATHIC

2 fl oz (60mL) / 20% Alcohol

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0669-2Throat60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0669THROAT (BAPTISIA, PHYTOLACCA, HYDRASTIS, APIS MEL, ARG NIT, BELLADONNA, HEPAR SULPH CALC, KALI BIC, LAC CAN, LACHESIS, MERC SOLUB) SPRAY [NATURAL CREATIONS, INC]1Current NDC, Legacy NDC, 1 package rows20230111_df764380-46e2-46fc-9b5b-a2eca71bbfbf.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-066943406-0669-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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
ThroatBAPTISIA, PHYTOLACCA, HYDRASTIS, APIS MEL, ARG NIT, BELLADONNA, HEPAR SULPH CALC, KALI BIC, LAC CAN, LACHESIS, MERC SOLUBNatural Creations, Incdf764380-46e2-46fc-9b5b-a2eca71bbfbf2018-12-21WarningsExact identifier
ndc (package): 43406-0669-2
ndc (product): 43406-0669
ndc11 (package): 43406066902
spl id: 05d23e4d-d629-44c0-8161-1b3a07c5493b
spl set id: df764380-46e2-46fc-9b5b-a2eca71bbfbf

Reported adverse events (FAERS/openFDA)#

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