FDA.reportPublic FDA data

Cough HP

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:38:14

Label at a glance#

ProductCough HP
Active ingredientARSENIC TRIOXIDE, BRYONIA ALBA ROOT, CUPRIC ACETATE, DROSERA ROTUNDIFOLIA WHOLE, IPECAC, POTASSIUM CARBONATE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SPONGIA OFFICINALIS SKELETON, ROASTED
Label structure9 sections

Indications and uses

For temporary relief of symptoms of chronic cough.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Arsenicum Album 30X, Bryonia (Alba) 30X, Cuprum Aceticum 30X, Drosera (Rotundifolia) 30X, Ipecacuanha 30X, Kali Carbonicum 30X, Phosphorus 30X, Pulsatilla (Vulgaris) 30X, Spongia Tosta 30X.

PURPOSE:

OTC - PURPOSE SECTION

Arsenicum Album – minor breathing issues,** Bryonia (Alba) – cough with yellowish mucus,** Cuprum Aceticum – irritating cough,** Drosera (Rotundifolia) – light cough,** Ipecacuanha – nasal decongestant,** Kali Carbonicum - congestion,** Phosphorus – sore throat,** Pulsatilla (Vulgaris) – nasal congestion,** Spongia Tosta – dry chesty cough**

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

USES:

INDICATIONS & USAGE SECTION

For temporary relief of symptoms of chronic cough.**

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

WARNINGS:

WARNINGS SECTION

Sore Throat Warning

Severe 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.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

COUGH-HP

HOMEOPATHIC

1 fl. oz. (30 mL)

COUGH-HPCOUGH-HP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130210184341442GTIN-13: 0210184341442
EAN-13: 0210184341442
GTIN-12: 210184341442
UPC-A: 210184341442
GTIN storage (14 digits): 00210184341442		BANI0083 Cough-HP 12-1-25.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0075-1Cough HP30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B1
CUPRIC ACETATEACTIVE INGREDIENT39M11XPH031
DROSERA ROTUNDIFOLIAACTIVE INGREDIENTQR44N9XPJQ1
IPECACACTIVE INGREDIENT62I3C8233L1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
POTASSIUM CARBONATEACTIVE INGREDIENTBQN1B9B9HA1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE INGREDIENT1PIP394IID1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7D1
CUPRIC CATIONACTIVE MOIETY8CBV67279L1
DROSERA ROTUNDIFOLIAACTIVE MOIETYQR44N9XPJQ1
IPECACACTIVE MOIETY62I3C8233L1
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE MOIETY1PIP394IID1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-007543857-0075-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CUPRIC ACETATE39M11XPH03ACTIB
DROSERA ROTUNDIFOLIA WHOLEQR44N9XPJQACTIB
IPECAC62I3C8233LACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
WATER059QF0KO0RIACT
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 · 2 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
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 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
Cough HPARSENICUM ALBUM, BRYONIA (ALBA), CUPRUM ACETICUM, DROSERA (ROTUNDIFOLIA), IPECACUANHA, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SPONGIA TOSTABioActive Nutritional, Inc.1e65f5de-3735-4ac7-b2ef-a91a68ffa6832026-03-31WarningsExact identifier
ndc (package): 43857-0075-1
ndc (product): 43857-0075
ndc11 (package): 43857007501
spl id: 2caa80b0-9ba0-43ec-b826-5e35e28ddfa4
spl set id: 1e65f5de-3735-4ac7-b2ef-a91a68ffa683

Reported adverse events (FAERS/openFDA)#

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