Sinus Tonic

Product NDC
43857-0532
11-digit product format
438570532
Labeler code
43857
Product ID
43857-0532_5faf3e52-7265-4246-9ad6-7bb3a8e4bbbd
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea (Angustifolia), Baptisia Tinctoria, Thiaminum Hydrochloricum, Hydrastis Canadensis, Pyridoxinum Hydrochloricum, Spongia Tosta, Apis Mellifica, Ascorbic Acid, Hepar Sulphuris Calcareum, Kali Bichromicum, Lachesis Mutus, Mercurius Iodatus Ruber, Mercurius Sulphuratus Ruber, Pulsatilla (Pratensis), Silicea, Sinusitisinum, Pantothenic Acid
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-01-02
Substance
APIS MELLIFERA; ASCORBIC ACID; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA WHOLE; GOLDENSEAL; LACHESIS MUTA VENOM; MERCURIC IODIDE; MERCURIC SULFIDE; PANTOTHENIC ACID; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE; PYRIDOXINE HYDROCHLORIDE; SILICON DIOXIDE; SINUSITISINUM; SPONGIA OFFICINALIS SKELETON, ROASTED; THIAMINE HYDROCHLORIDE
Active strength
12; 12; 3; 12; 1; 5; 12; 12; 12; 28; 12; 12; 6; 12; 30; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus TonicECHINACEA (ANGUSTIFOLIA), BAPTISIA TINCTORIA, THIAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, PYRIDOXINUM HYDROCHLORICUM, SPONGIA TOSTA, APIS MELLIFICA, ASCORBIC ACID, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LACHESIS MUTUS, MERCURIUS IODATUS RUBER, MERCURIUS SULPHURATUS RUBER, PULSATILLA (PRATENSIS), SILICEA, SINUSITISINUM, PANTOTHENIC ACIDBioActive Nutritional, Inc.63234fdc-7456-42c6-8996-fef372dd4a532025-05-20WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS: Sore Throat Warning S evere or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician. If pregnant or breast-feeding, ask a health care 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.

Additional Listing Data#

Finished product
Yes
Brand name base
Sinus Tonic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECHINACEA ANGUSTIFOLIA WHOLE12 [hp_X]/mL
BAPTISIA TINCTORIA ROOT12 [hp_X]/mL
THIAMINE HYDROCHLORIDE3 [hp_X]/mL
GOLDENSEAL12 [hp_X]/mL
PYRIDOXINE HYDROCHLORIDE1 [hp_X]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED5 [hp_X]/mL
APIS MELLIFERA12 [hp_X]/mL
ASCORBIC ACID12 [hp_X]/mL
CALCIUM SULFIDE12 [hp_X]/mL
POTASSIUM DICHROMATE28 [hp_C]/mL
LACHESIS MUTA VENOM12 [hp_X]/mL
MERCURIC IODIDE12 [hp_X]/mL
MERCURIC SULFIDE6 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE12 [hp_X]/mL
SILICON DIOXIDE30 [hp_X]/mL
SINUSITISINUM6 [hp_X]/mL
PANTOTHENIC ACID4 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB06AV5US8, 5EF0HWI5WU, M572600E5P, ZW3Z11D0JV, 68Y4CF58BV, 1PIP394IID, 7S82P3R43Z, PQ6CK8PD0R, 1MBW07J51Q, T4423S18FM, VSW71SS07I, R03O05RB0P, ZI0T668SF1, 8E272251DI, ETJ7Z6XBU4, B575563DM5, 19F5HK2737

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0532-12024-03-26C16284748780-1d6a99b39-3761-a426-e053-dadaa90af4c2DRUG FACTS:
43857-0532-12022-01-28C16284748780-1d6a99b39-3761-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0532-1Sinus Tonic60 mL in 1 BOTTLE, DROPPERLIQUID603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0532SINUS TONIC (ECHINACEA (ANGUSTIFOLIA), BAPTISIA TINCTORIA, THIAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, PYRIDOXINUM HYDROCHLORICUM, SPONGIA TOSTA, APIS MELLIFICA, ASCORBIC ACID, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LACHESIS MUTUS, MERCURIUS IODATUS RUBER, MERCURIUS SULPHURATUS RUBER, PULSATILLA (PRATENSIS), SILICEA, SINUSITISINUM, PANTOTHENIC ACID) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20250522_63234fdc-7456-42c6-8996-fef372dd4a53.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0532-14385705320160 mL in 1 BOTTLE, DROPPER (43857-0532-1) 60 ml2020-01-020000-00-00NoNoCurrent