COLIC CP
- Manufacturer
- Natural Creations, Inc. | OHM Pharma, Inc.
- Effective date
- 2022-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:19:26
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aethusa Cynapium 30X, Alumina 30X, Bryonia Alba 30X, Calcarea Carbonica 30X, Chamomilla 30X, Lycopodium Clavatum 30X, Phosphorus 30X, Pulsatilla 30X, Silicea 30X, Sulphur 30X.
OTC - PURPOSE SECTION
USES: Temporarily relieves occasional crying with irritability.**
INDICATIONS & USAGE SECTION
USES: Temporarily relieves occasional crying with irritability.**
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.
- 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 AND 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: 43406-0056-1
COLIC CP
HOMEOPATHIC
1 fl oz (30 mL) / 20% Alcohol
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43406-0056-1 | 2023-01-10 | C162847 | 48780-1 | 9d75b9d0-a4b9-f424-e053-dadaa90a57ce | COLIC CP |
| 43406-0056-1 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d0-a4b9-f424-e053-dadaa90a57ce | COLIC CP |
| 43406-0056-1 | 2020-04-02 | C162847 | 48780-1 | 9d75b9d0-a4b9-f424-e053-dadaa90a57ce | COLIC CP |
| 43406-0056-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a4b9-f424-e053-dadaa90a57ce | COLIC CP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43406-0056-1 | COLIC CP | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43406-0056 | COLIC CP (AETHUSA CYNAPIUM, ALUMINUM OXIDE, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, ANEMONE PULSATILLA, SILICON DIOXIDE, SULFUR.) LIQUID [NATURAL CREATIONS, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230111_7c2a2f6e-a332-4c68-a7a8-fdc390f1827e.zip |
Products#
Every source-derived product name is available through these pages.
- COLIC CP
- Aethusa Cynapium, Aluminum Oxide, Bryonia Alba Root, Oyster Shell Calcium Carbonate Crude, Matricaria Recutita, Lycopodium Clavatum Spore, Phosphorus, Anemone Pulsatilla, Silicon Dioxide, Sulfur.
- AETHUSA CYNAPIUM
- ALUMINUM OXIDE
- BRYONIA ALBA ROOT
- OYSTER SHELL CALCIUM CARBONATE, CRUDE
- MATRICARIA RECUTITA
- LYCOPODIUM CLAVATUM SPORE
- PHOSPHORUS
- ANEMONE PULSATILLA
- SILICON DIOXIDE
- SULFUR
- CITRIC ACID ACETATE
- GLYCERIN
- POTASSIUM SORBATE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43406-0056 | 43406-0056-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| AETHUSA CYNAPIUM | M6936L953C | ACTIB |
| ALUMINUM OXIDE | LMI26O6933 | ACTIB |
| BRYONIA ALBA ROOT | T7J046YI2B | ACTIB |
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | 2E32821G6I | ACTIB |
| MATRICARIA RECUTITA | G0R4UBI2ZZ | ACTIB |
| LYCOPODIUM CLAVATUM SPORE | C88X29Y479 | ACTIB |
| PHOSPHORUS | 27YLU75U4W | ACTIB |
| ANEMONE PULSATILLA | I76KB35JEV | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | ACTIB |
| SULFUR | 70FD1KFU70 | ACTIB |
| CITRIC ACID ACETATE | DSO12WL7AU | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| COLIC CP | AETHUSA CYNAPIUM, ALUMINUM OXIDE, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, ANEMONE PULSATILLA, SILICON DIOXIDE, SULFUR. | Natural Creations, Inc. | 7c2a2f6e-a332-4c68-a7a8-fdc390f1827e | 2022-12-19 | Warnings | 43406-0056-1 43406-0056 43406005601 d01271a6-becf-465b-86d6-1e4c51f97f0d 7c2a2f6e-a332-4c68-a7a8-fdc390f1827e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
