CALMING COMPOSITION

Manufacturer: Synergy Formulas, Inc. | Apotheca Company
Effective date: 2014-11-17
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:06:10

Label at a glance#

ProductCALMING COMPOSITION

Active ingredientHOPS, VALERIAN, AVENA SATIVA FLOWERING TOP, SCUTELLARIA LATERIFLORA, FERULA SUMBUL ROOT, MELILOTUS OFFICINALIS TOP, PASSIFLORA INCARNATA FLOWERING TOP, PHOSPHORUS, STRYCHNOS IGNATII SEED, MOSCHUS MOSCHIFERUS MUSK SAC RESIN, ZINC, SUS SCROFA ADRENAL GLAND, SUS SCROFA HYPOTHALAMUS, PULSATILLA VULGARIS, ACONITUM NAPELLUS, FERULA COMMUNIS SUBSP. GLAUCA

Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

HUMULUS LUPULUS 1X, 3X, VALERIANA OFFICINALIS 1X, 3X, AVENA SATIVA 1X, 6X, 30X, SCUTELLARIA LATERIFLORA 2X, 3X, SUMBUL 3X, MELILOTUS OFFICINALIS 3X, 6X, PASSIFLORA INCARNATA 3X, 6X, PHOSPHORUS 6X, 8X, 12X, IGNATIA AMARA 6X, 12X, MOSCHUS 8X, 10X, ZINCUM METALLICUM 8X, 12X, GLANDULA SUPRARENALIS SUIS 8X, 30X, HYPOTHALAMUS (SUIS) 8X, 30X, PULSATILLA (VULGARIS) 30X, ACONITUM NAPELLUS 30X, 100X, FERULA GLAUCA 6C

INDICATIONS:

OTC - PURPOSE SECTION

Provides temporary relief of tickling cough, troublesome at night. Pains in the joints, and bones. Cramps in calves and soles of feet.

WARNINGS:

WARNINGS SECTION

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

If pregnant or breast-feeding, ask a health professional before use.

Do not use if tamper evident seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

Provides temporary relief of tickling cough, troublesome at night. Pains in the joints, and bones. Cramps in calves and soles of feet.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

SYNERGY FORMULAS, INC.

251 West Road

Campobello, SC 29322

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Synergy Formulas

CALMING COMPOSITION

HOMEOPATHIC

2 FL OZ (60 ml)

CALMING COMPOSITION 2 oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43772-0044-1	2020-01-31	C162847	48780-1	9d75b9d1-15b4-f424-e053-dadaa90a57ce	DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43772-0044-1	CALMING COMPOSITION	60 mL in 1 BOTTLE, DROPPER	LIQUID	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43772-0044	CALMING COMPOSITION (NOT APPLICABLE) LIQUID [SYNERGY FORMULAS, INC.]	1	Legacy NDC, 1 package rows	20141119_cb740345-43fd-4f27-a182-62293a5c2e48.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACONITUM NAPELLUS	ACTIVE INGREDIENT	U0NQ8555JD	1
AVENA SATIVA FLOWERING TOP	ACTIVE INGREDIENT	MA9CQJ3F7F	1
FERULA COMMUNIS SUBSP. GLAUCA	ACTIVE INGREDIENT	5S9H7NQT11	1
FERULA SUMBUL ROOT	ACTIVE INGREDIENT	GLA4808EHQ	1
HOPS	ACTIVE INGREDIENT	01G73H6H83	1
MELILOTUS OFFICINALIS TOP	ACTIVE INGREDIENT	GM6P02J2DX	1
MOSCHUS MOSCHIFERUS MUSK SAC RESIN	ACTIVE INGREDIENT	8KFK4W7KP7	1
PASSIFLORA INCARNATA FLOWERING TOP	ACTIVE INGREDIENT	CLF5YFS11O	1
PHOSPHORUS	ACTIVE INGREDIENT	27YLU75U4W	1
PULSATILLA VULGARIS	ACTIVE INGREDIENT	I76KB35JEV	1
SCUTELLARIA LATERIFLORA	ACTIVE INGREDIENT	7BP4DH5PDC	1
STRYCHNOS IGNATII SEED	ACTIVE INGREDIENT	1NM3M2487K	1
SUS SCROFA ADRENAL GLAND	ACTIVE INGREDIENT	398IYQ16YV	1
SUS SCROFA HYPOTHALAMUS	ACTIVE INGREDIENT	N6R0856Z79	1
VALERIAN	ACTIVE INGREDIENT	JWF5YAW3QW	1
ZINC	ACTIVE INGREDIENT	J41CSQ7QDS	1
ACONITUM NAPELLUS	ACTIVE MOIETY	U0NQ8555JD	1
AVENA SATIVA FLOWERING TOP	ACTIVE MOIETY	MA9CQJ3F7F	1
FERULA COMMUNIS SUBSP. GLAUCA	ACTIVE MOIETY	5S9H7NQT11	1
FERULA SUMBUL ROOT	ACTIVE MOIETY	GLA4808EHQ	1
HOPS	ACTIVE MOIETY	01G73H6H83	1
MELILOTUS OFFICINALIS TOP	ACTIVE MOIETY	GM6P02J2DX	1
MOSCHUS MOSCHIFERUS MUSK SAC RESIN	ACTIVE MOIETY	8KFK4W7KP7	1
PASSIFLORA INCARNATA FLOWERING TOP	ACTIVE MOIETY	CLF5YFS11O	1
PHOSPHORUS	ACTIVE MOIETY	27YLU75U4W	1
PULSATILLA VULGARIS	ACTIVE MOIETY	I76KB35JEV	1
SCUTELLARIA LATERIFLORA	ACTIVE MOIETY	7BP4DH5PDC	1
STRYCHNOS IGNATII SEED	ACTIVE MOIETY	1NM3M2487K	1
SUS SCROFA ADRENAL GLAND	ACTIVE MOIETY	398IYQ16YV	1
SUS SCROFA HYPOTHALAMUS	ACTIVE MOIETY	N6R0856Z79	1
VALERIAN	ACTIVE MOIETY	JWF5YAW3QW	1
ZINC	ACTIVE MOIETY	J41CSQ7QDS	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

CALMING COMPOSITION
NOT APPLICABLE
HOPS
VALERIAN
AVENA SATIVA FLOWERING TOP
SCUTELLARIA LATERIFLORA
FERULA SUMBUL ROOT
MELILOTUS OFFICINALIS TOP
PASSIFLORA INCARNATA FLOWERING TOP
PHOSPHORUS
STRYCHNOS IGNATII SEED
MOSCHUS MOSCHIFERUS MUSK SAC RESIN
ZINC
SUS SCROFA ADRENAL GLAND
SUS SCROFA HYPOTHALAMUS
PULSATILLA VULGARIS
ACONITUM NAPELLUS
FERULA COMMUNIS SUBSP. GLAUCA
WATER
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43772-0044	43772-0044-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HOPS	01G73H6H83	ACTIB
VALERIAN	JWF5YAW3QW	ACTIB
AVENA SATIVA FLOWERING TOP	MA9CQJ3F7F	ACTIB
SCUTELLARIA LATERIFLORA	7BP4DH5PDC	ACTIB
FERULA SUMBUL ROOT	GLA4808EHQ	ACTIB
MELILOTUS OFFICINALIS TOP	GM6P02J2DX	ACTIB
PASSIFLORA INCARNATA FLOWERING TOP	CLF5YFS11O	ACTIB
PHOSPHORUS	27YLU75U4W	ACTIB
STRYCHNOS IGNATII SEED	1NM3M2487K	ACTIB
MOSCHUS MOSCHIFERUS MUSK SAC RESIN	8KFK4W7KP7	ACTIB
ZINC	J41CSQ7QDS	ACTIB
SUS SCROFA ADRENAL GLAND	398IYQ16YV	ACTIB
SUS SCROFA HYPOTHALAMUS	N6R0856Z79	ACTIB
PULSATILLA VULGARIS	I76KB35JEV	ACTIB
ACONITUM NAPELLUS	U0NQ8555JD	ACTIB
FERULA COMMUNIS SUBSP. GLAUCA	5S9H7NQT11	ACTIB
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
149cd648-cafd-44f7-9277-d7f26b77969d			cb740345-43fd-4f27-a182-62293a5c2e48	2014-11-17	Warnings	Exact identifier spl id: 149cd648-cafd-44f7-9277-d7f26b77969d spl set id: cb740345-43fd-4f27-a182-62293a5c2e48

Reported adverse events (FAERS/openFDA)#

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