FDA.reportPublic FDA data

CROUP CP

Manufacturer
Natural Creations, Inc | OHM Pharma, Inc
Effective date
2022-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:26

Label at a glance#

ProductCROUP CP
Active ingredientACONITUM NAPELLUS, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM SULFIDE, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, ANEMONE PULSATILLA, SAMBUCUS NIGRA FLOWERING TOP, SPONGIA OFFICINALIS SKELETON, ROASTED, SULFUR
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum Nap 30X, Calc Carb 30X, Hepar Sulph Calc 30X, Lachesis 30X, Lycopodium 30X, Phosphorus 30X, Pulsatilla 30X, Sambucus Nig 30X, Spongia 30X, Sulphur 30X.

INDICATIONS & USAGE SECTION

USES: Temporarily relieves croup-like cough, painful cough, tickling cough &/or a dry, hacking cough.**

OTC - PURPOSE SECTION

USES: Temporarily relieves croup-like cough, painful cough, tickling cough &/or a dry, hacking cough.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: 10 drops orally 3 times daily, 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:

  • 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 persistant 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: Citric Acid, Glycerin, Natural Cherry Flavor, Potassium Sorbate, Purified Water.

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

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

REFERENCES SECTION

*The letters "HPUS" indicate that the components in this 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: 43406-0058-1

CROUP CP

HOMEOPATHIC

1 fl oz (30 mL) / Alcohol Free

Natural Cherry Flavor

877730001092

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0058-12023-01-10C16284748780-1ba0f9c33-1042-a910-e053-dadaa90a0b85CROUP CP
43406-0058-12021-01-29C16284748780-1ba0f9c33-1042-a910-e053-dadaa90a0b85CROUP CP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0058-1CROUP CP30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0058CROUP CP (ACONITUM NAPELLUS, CALCAREA CARBONICA, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA, SAMBUCUS NIGRA, SPONGIA TOSTA, SULPHUR) LIQUID [NATURAL CREATIONS, INC]2Current NDC, Legacy NDC, 1 package rows20230111_78bab8d8-0d28-449b-b9d8-dc4222ce5147.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-005843406-0058-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACONITUM NAPELLUSU0NQ8555JDACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
SULFUR70FD1KFU70ACTIB
CITRIC ACID ACETATEDSO12WL7AUIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT

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
CROUP CPACONITUM NAPELLUS, CALCAREA CARBONICA, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA, SAMBUCUS NIGRA, SPONGIA TOSTA, SULPHURNatural Creations, Inc78bab8d8-0d28-449b-b9d8-dc4222ce51472022-12-19WarningsExact identifier
ndc (package): 43406-0058-1
ndc (product): 43406-0058
ndc11 (package): 43406005801
spl id: 1de2deb3-d795-4b70-9a97-7296fe274c76
spl set id: 78bab8d8-0d28-449b-b9d8-dc4222ce5147

Reported adverse events (FAERS/openFDA)#

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