Sore Throat Spray
- Manufacturer
- Apotheca Company
- Effective date
- 2010-06-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:02:20
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS: Echinacea purpurea 2X, Plantago major 2X, Baptisia tinctoria 3X, Phytolacca decandra 3X, Apil mellifica 12X, Belladonna 12X, Lachesis mutus 12X, Mercurius solubilis 12X, Hepar sulphuris calcareum 15X.
OTC - PURPOSE SECTION
INDICATIONS: For the symptomatic relief of monor pain associated with sore throat, difficulty swallowing, speaking, hoarseness or canker sores.
WARNINGS SECTION
WARNINGS: If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.
WARNING: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more that two days or administer to children under 3 years of age unless directed by a physician.
Recommended for Professional Use.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS: Adults and children over 12 years of age, at onset of symptoms, spray throat every 3 hours. Consult a physician for use in children under 12 years of age.
To be used according to standard homeopathic indications or as directed by a homeopathic physician.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS: Demineralized water, 23% Ethanol, Glycerin, Herbal Base [Clove (Flower), Goldenseal (Root), Myrrh (Resin), Sage (Leaf), Thyme (Leaf)], Marshmallow flavor, Menthol, Spearmint oil, Stevia 90% Powered Extract, Teaberry oil.
OTC - QUESTIONS SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PROFESSIONAL HEALTH PRODUCTS
SORE THROAT SPRAY
HOMEOPATHIC
C63 (reorder code)
NET 1 FL. OZ. (30 ML)
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0649818191007 | GTIN-13: 0649818191007 EAN-13: 0649818191007 GTIN-12: 649818191007 UPC-A: 649818191007 GTIN storage (14 digits): 00649818191007 | mm1.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bee4fa8d-8d82-423a-a0b5-40a89dd13a99 | Product name | 1 | 20250618 |
| e0d2eb29-08bd-4bba-90d1-c91c68a38767 | Product name | 4 | 20250516 |
| 30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2 | Product name | 5 | 20250304 |
| 334fe8d2-68fb-4331-a576-420e302ec069 | Product name | 7 | 20240320 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| e92765c1-be81-432a-b909-1b10777ec378 | Product name | 1 | 20190208 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 0441a8f5-3835-497c-aedd-bc78cba56b2a | Product name | 1 | 20150317 |
| 87711080-88eb-65c5-b2dd-bf99e700a372 | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57520-0157-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ffad-f424-e053-dadaa90a57ce | Sore Throat Spray |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57520-0157-1 | Sore Throat | 30 mL in 1 BOTTLE, SPRAY | SPRAY | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 57520-0157 | SORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY] | 2 | Legacy NDC, 1 package rows | 20100629_5276bc49-c405-4375-b6e5-2d9a7afa95f4.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| APIS MELLIFERA | ACTIVE INGREDIENT | 7S82P3R43Z | 2 | |
| ATROPA BELLADONNA | ACTIVE INGREDIENT | WQZ3G9PF0H | 2 | |
| BAPTISIA TINCTORIA ROOT | ACTIVE INGREDIENT | 5EF0HWI5WU | 2 | |
| CALCIUM SULFIDE | ACTIVE INGREDIENT | 1MBW07J51Q | 2 | |
| ECHINACEA PURPUREA | ACTIVE INGREDIENT | QI7G114Y98 | 2 | |
| LACHESIS MUTA VENOM | ACTIVE INGREDIENT | VSW71SS07I | 2 | |
| MERCURIUS SOLUBILIS | ACTIVE INGREDIENT | 324Y4038G2 | 2 | |
| PHYTOLACCA AMERICANA ROOT | ACTIVE INGREDIENT | 11E6VI8VEG | 2 | |
| PLANTAGO MAJOR | ACTIVE INGREDIENT | W2469WNO6U | 2 | |
| APIS MELLIFERA | ACTIVE MOIETY | 7S82P3R43Z | 2 | |
| ATROPA BELLADONNA | ACTIVE MOIETY | WQZ3G9PF0H | 2 | |
| BAPTISIA TINCTORIA ROOT | ACTIVE MOIETY | 5EF0HWI5WU | 2 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 2 | |
| ECHINACEA PURPUREA | ACTIVE MOIETY | QI7G114Y98 | 2 | |
| LACHESIS MUTA VENOM | ACTIVE MOIETY | VSW71SS07I | 2 | |
| MERCURIUS SOLUBILIS | ACTIVE MOIETY | 324Y4038G2 | 2 | |
| PHYTOLACCA AMERICANA ROOT | ACTIVE MOIETY | 11E6VI8VEG | 2 | |
| PLANTAGO MAJOR | ACTIVE MOIETY | W2469WNO6U | 2 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 2 | |
| CLOVE | INACTIVE INGREDIENT | K48IKT5321 | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| GOLDENSEAL | INACTIVE INGREDIENT | ZW3Z11D0JV | 2 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | 2 | |
| METHYL SALICYLATE | INACTIVE INGREDIENT | LAV5U5022Y | 2 | |
| MYRRH | INACTIVE INGREDIENT | JC71GJ1F3L | 2 | |
| SAGE | INACTIVE INGREDIENT | 065C5D077J | 2 | |
| SPEARMINT OIL | INACTIVE INGREDIENT | C3M81465G5 | 2 | |
| STEVIA LEAF | INACTIVE INGREDIENT | 6TC6NN0876 | 2 | |
| THYME | INACTIVE INGREDIENT | CW657OBU4N | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Sore Throat
- Echinacea purpurea, Plantago major, Baptisia tinctoria
- ECHINACEA PURPUREA
- PLANTAGO MAJOR
- BAPTISIA TINCTORIA ROOT
- PHYTOLACCA AMERICANA ROOT
- APIS MELLIFERA
- ATROPA BELLADONNA
- LACHESIS MUTA VENOM
- MERCURIUS SOLUBILIS
- CALCIUM SULFIDE
- CALCIUM CATION
- CLOVE
- GOLDENSEAL
- MYRRH
- SAGE
- THYME
- WATER
- ALCOHOL
- GLYCERIN
- MENTHOL
- SPEARMINT OIL
- STEVIA LEAF
- METHYL SALICYLATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57520-0157 | 57520-0157-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ECHINACEA PURPUREA | QI7G114Y98 | ACTIB |
| PLANTAGO MAJOR | W2469WNO6U | ACTIB |
| BAPTISIA TINCTORIA ROOT | 5EF0HWI5WU | ACTIB |
| PHYTOLACCA AMERICANA ROOT | 11E6VI8VEG | ACTIB |
| APIS MELLIFERA | 7S82P3R43Z | ACTIB |
| ATROPA BELLADONNA | WQZ3G9PF0H | ACTIB |
| LACHESIS MUTA VENOM | VSW71SS07I | ACTIB |
| MERCURIUS SOLUBILIS | 324Y4038G2 | ACTIB |
| CALCIUM SULFIDE | 1MBW07J51Q | ACTIB |
| CLOVE | K48IKT5321 | IACT |
| GOLDENSEAL | ZW3Z11D0JV | IACT |
| MYRRH | JC71GJ1F3L | IACT |
| SAGE | 065C5D077J | IACT |
| THYME | CW657OBU4N | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| SPEARMINT OIL | C3M81465G5 | IACT |
| STEVIA LEAF | 6TC6NN0876 | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | DROPS / NASAL | 40.32 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SUSPENSION / ORAL | 1 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | POWDER, DENTIFRICE / DENTAL | NA | ||
| MENTHOL | MENTHOL | L7T10EIP3A | LOTION / TOPICAL | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CONCENTRATE / ORAL | 0.05 mg/5ml | ||
| MENTHOL | MENTHOL | L7T10EIP3A | INHALANT / NASAL | 32 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| MENTHOL | MENTHOL | L7T10EIP3A | JELLY / NASAL | 32.5 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | GEL / TOPICAL | 0.1 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| SPEARMINT OIL | SPEARMINT OIL | C3M81465G5 | OINTMENT / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| SPEARMINT OIL | SPEARMINT OIL | C3M81465G5 | SOLUTION / ORAL | NA | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SYRUP / ORAL | 7.5 mg/5ml | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | CAPSULE / ORAL | 16 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CREAM / TOPICAL | 0.1 %w/w | ||
| MENTHOL | MENTHOL | L7T10EIP3A | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.02 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | POWDER, FOR SOLUTION / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | POWDER / TOPICAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | DROPS / OPHTHALMIC | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| c8b67091-950b-477e-9a6a-268704b521d3 | 5276bc49-c405-4375-b6e5-2d9a7afa95f4 | 2010-06-29 | Warnings | c8b67091-950b-477e-9a6a-268704b521d3 5276bc49-c405-4375-b6e5-2d9a7afa95f4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
