FDA.reportPublic FDA data

Throat Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:44

Label at a glance#

ProductThroat Care
Active ingredientAconitum Napellus, Apis Mellifera, Arisaema Dracontium Root, Atropa Belladonna, Bryonia Alba Root, Cajuput Oil, Ferrosoferric Phosphate, Glycyrrhiza Glabra, Potassium Dichromate, Lachesis Muta Venom, Mentha Piperita, Mercury, Naja Naja Venom, Sodium Carbonate, Sodium Sulfate, Nitric Acid, Strychnos Nux-vomica Seed, Phosphorus, Phytolacca Americana Root, Pulsatilla Vulgaris, Spongia Officinalis Skeleton, Roasted, Tin, Lobaria Pulmonaria, Thuja Occidentalis Leafy Twig, Ulmus Rubra Bark, Verbascum Thapsus, Echinacea, Unspecified
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Throat Care  Formulated for symptoms associated with throat conditions such as dryness, irritation, inflammation, pain and hoarseness.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap. 15x, Apis mel. 15x, Arum dracontium 15x, Belladonna 15x, Bryonia 15x, Cajuputum 15x, Ferrum phosphoricum 15x, Glycyrrhiza glabra 15x, Kali bic.15x, Lachesis 15x, Mentha piperita 15x, Merc. viv. 15x, Naja 15x, Nat. carb. 15x, Nat. sulphuricum 15x, Nitricum ac. 15x, Nux vom.15x, Phosphorus 15x, Phytolacca 15x, Pulsatilla 15x, Spongia 15x, Stannum met. 15x, Sticta 15x, Thuja occ. 15x, Ulmus fulva 15x, Verbascum 15x, Echinacea 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with throat conditions such as dryness, irritation, inflammation, pain and hoarseness.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2248-02020-01-31C16284748780-19d75b9d0-6aa5-f424-e053-dadaa90a57ceThroat Care
55714-2248-12020-01-31C16284748780-19d75b9d0-6aa5-f424-e053-dadaa90a57ceThroat Care
55714-2248-22020-01-31C16284748780-19d75b9d0-6aa5-f424-e053-dadaa90a57ceThroat Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2248-0Throat Care.5 mL in 1 BOTTLE, GLASSLIQUID.52
55714-2248-1Throat Care29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-2248-2Throat Care59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2248THROAT CARE (ACONITUM NAP., APIS MEL., ARUM DRACONTIUM, BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOSPHORICUM, GLYCYRRHIZA GLABRA, KALI BIC., LACHESIS, MENTHA PIPERITA, MERC. VIV., NAJA, NAT. CARB., NAT. SULPHURICUM, NITRICUM AC., NUX VOM., PHOSPHORUS, PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULVA, VERBASCUM, ECHINACEA) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 3 package rows20130730_407781ed-54e1-eb96-3fd1-a8d72d2bd25b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD2
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z2
Arisaema Dracontium RootACTIVE INGREDIENT73BHJ429FF2
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H2
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Cajuput OilACTIVE INGREDIENTJ3TO6BUQ372
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
Ferrosoferric PhosphateACTIVE INGREDIENT91GQH8I5F72
Glycyrrhiza GlabraACTIVE INGREDIENT2788Z9758H2
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I2
Lobaria PulmonariaACTIVE INGREDIENTD1YM0P5Z2T2
Mentha PiperitaACTIVE INGREDIENT79M2M2UDA92
MercuryACTIVE INGREDIENTFXS1BY2PGL2
Naja Naja VenomACTIVE INGREDIENTZZ4AG7L7VM2
Nitric AcidACTIVE INGREDIENT411VRN1TV42
PhosphorusACTIVE INGREDIENT27YLU75U4W2
Phytolacca Americana RootACTIVE INGREDIENT11E6VI8VEG2
Potassium DichromateACTIVE INGREDIENTT4423S18FM2
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV2
Sodium CarbonateACTIVE INGREDIENT45P3261C7T2
Sodium SulfateACTIVE INGREDIENT0YPR65R21J2
Spongia Officinalis Skeleton, RoastedACTIVE INGREDIENT1PIP394IID2
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139192
Thuja Occidentalis Leafy TwigACTIVE INGREDIENT1NT28V93972
TinACTIVE INGREDIENT387GMG9FH52
Ulmus Rubra BarkACTIVE INGREDIENT91QY4PXU8Q2
Verbascum ThapsusACTIVE INGREDIENTC9TD27U1722
Aconitum NapellusACTIVE MOIETYU0NQ8555JD2
Apis MelliferaACTIVE MOIETY7S82P3R43Z2
Arisaema Dracontium RootACTIVE MOIETY73BHJ429FF2
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Cajuput OilACTIVE MOIETYJ3TO6BUQ372
Carbonate IonACTIVE MOIETY7UJQ5OPE7D2
Dichromate IonACTIVE MOIETY9LKY4BFN2V2
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
Ferrosoferric PhosphateACTIVE MOIETY91GQH8I5F72
Glycyrrhiza GlabraACTIVE MOIETY2788Z9758H2
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I2
Lobaria PulmonariaACTIVE MOIETYD1YM0P5Z2T2
Mentha PiperitaACTIVE MOIETY79M2M2UDA92
MercuryACTIVE MOIETYFXS1BY2PGL2
Naja Naja VenomACTIVE MOIETYZZ4AG7L7VM2
Nitric AcidACTIVE MOIETY411VRN1TV42
PhosphorusACTIVE MOIETY27YLU75U4W2
Phytolacca Americana RootACTIVE MOIETY11E6VI8VEG2
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV2
Sodium Sulfate AnhydrousACTIVE MOIETY36KCS0R7502
Spongia Officinalis Skeleton, RoastedACTIVE MOIETY1PIP394IID2
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139192
Thuja Occidentalis Leafy TwigACTIVE MOIETY1NT28V93972
TinACTIVE MOIETY387GMG9FH52
Ulmus Rubra BarkACTIVE MOIETY91QY4PXU8Q2
Verbascum ThapsusACTIVE MOIETYC9TD27U1722
AlcoholINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-224855714-2248-1, 55714-2248-2, 55714-2248-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
Aconitum NapellusU0NQ8555JDACTIB
Apis Mellifera7S82P3R43ZACTIB
Arisaema Dracontium Root73BHJ429FFACTIB
Atropa BelladonnaWQZ3G9PF0HACTIB
Bryonia Alba RootT7J046YI2BACTIB
Cajuput OilJ3TO6BUQ37ACTIB
Ferrosoferric Phosphate91GQH8I5F7ACTIB
Glycyrrhiza Glabra2788Z9758HACTIB
Potassium DichromateT4423S18FMACTIB
Lachesis Muta VenomVSW71SS07IACTIB
Mentha Piperita79M2M2UDA9ACTIB
MercuryFXS1BY2PGLACTIB
Naja Naja VenomZZ4AG7L7VMACTIB
Sodium Carbonate45P3261C7TACTIB
Sodium Sulfate0YPR65R21JACTIB
Nitric Acid411VRN1TV4ACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Phosphorus27YLU75U4WACTIB
Phytolacca Americana Root11E6VI8VEGACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Spongia Officinalis Skeleton, Roasted1PIP394IIDACTIB
Tin387GMG9FH5ACTIB
Lobaria PulmonariaD1YM0P5Z2TACTIB
Thuja Occidentalis Leafy Twig1NT28V9397ACTIB
Ulmus Rubra Bark91QY4PXU8QACTIB
Verbascum ThapsusC9TD27U172ACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 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
54cbb3c6-c697-04da-42bf-14f3996e6172407781ed-54e1-eb96-3fd1-a8d72d2bd25b2011-03-01WarningsExact identifier
spl id: 54cbb3c6-c697-04da-42bf-14f3996e6172
spl set id: 407781ed-54e1-eb96-3fd1-a8d72d2bd25b

Reported adverse events (FAERS/openFDA)#

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