FDA.reportPublic FDA data

Sleepy Time CP

Manufacturer
Natural Creations, Inc | OHM Pharma, Inc
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:35:56

Label at a glance#

ProductSleepy Time CP
Active ingredientACONITUM NAPELLUS WHOLE, ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARABICA COFFEE BEAN, MAGNESIUM, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS WHOLE, SEPIA OFFICINALIS JUICE, SULFUR
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum 30X, Arsenicum Alb 30X, Calc Carb 30X, Coffea Cruda 30X, Magnesium Met 30X, Nux Vom 30X, Pulsatilla 30X, Sepia 30X, Sulphur 30X

INDICATIONS & USAGE SECTION

USES: Temporarily relieves occasional sleeplessness.**

OTC - PURPOSE SECTION

USES: Temporarily relieves occasional sleeplessness.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years: 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.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Citric Acid, Glycerin USP, 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 the components in the 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:43406-0675-1

Sleepy Time CP

HOMEOPATHIC

1 fl oz (30mL) / Alcohol Free

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130877730002716GTIN-13: 0877730002716
EAN-13: 0877730002716
GTIN-12: 877730002716
UPC-A: 877730002716
GTIN storage (14 digits): 00877730002716		Sleepy Time CP.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0675-1Sleepy Time CP30 mL in 1 BOTTLE, DROPPERLIQUID302

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
43406-067543406-0675-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
MAGNESIUMI38ZP9992AACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFUR70FD1KFU70ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
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
Sleepy Time CPACONITUM, ARSENICUM ALB, CALC CARB, COFFEA CRUDA, MAGNESIUM MET, NUX VOM, PULSATILLA, SEPIA, SULPHURNatural Creations, Inc03cbb408-7e2a-49e8-b83a-b8d932a104592025-12-16WarningsExact identifier
ndc (package): 43406-0675-1
ndc (product): 43406-0675
ndc11 (package): 43406067501
spl id: b30c6c13-693d-4b4a-b6f6-e1a0f196c1c4
spl set id: 03cbb408-7e2a-49e8-b83a-b8d932a10459

Reported adverse events (FAERS/openFDA)#

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