FDA.reportPublic FDA data

Calm

Manufacturer
Hyland's Inc.
Effective date
2025-03-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:32:41

Label at a glance#

ProductCalm
Active ingredientFERROSOFERRIC PHOSPHATE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, TRIBASIC CALCIUM PHOSPHATE
Label structure11 sections

Indications and uses

■ Helps temporarily relieves symptoms of: ■ restlessness ■ anxiousness ■ nervousness ■ irritability ■ apprehensiveness

Dosage and administration

■ Use as directed. Adults and children 12 years and over: ■ Dissolve 1-2 tablets under tongue 3 times per day. ■ Sudden onset: every 15 minutes until relieved, up to 6 doses.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Natural relief of anxiousness, nervousness and irritability

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Purpose

Calcarea Phosphorica 3X HPUS

restlessness, anxiousness

Ferrum Phosphoricum 3X HPUS

nervousness

Kali Phosphoricum 3X HPUS

irritability, anxiousness, nervousness

Natrum Phosphoricum 3X HPUS

irritability, anxiousness and apprehensiveness

Magnesia Phosphorica 3X HPUS

anxiousness

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

SPL UNCLASSIFIED SECTION

Indications and Usage

RECENT MAJOR CHANGES SECTION

■ Helps temporarily relieves symptoms of:

■ restlessness ■ anxiousness ■ nervousness

■ irritability ■ apprehensiveness

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist more than 7 days or worsen.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use as directed.

Adults and children 12 years and over: ■ Dissolve 1-2 tablets under tongue 3 times per day. ■ Sudden onset: every 15 minutes until relieved, up to 6 doses.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Indications and Usage (Uses)

RECENT MAJOR CHANGES SECTION

■ Helps temporarily relieves symptoms of:

■ restlessness ■ anxiousness ■ nervousness

■ irritability  ■ apprehensiveness

Dosage and Administration (Directions)

RECENT MAJOR CHANGES SECTION

Dissolve 1-2 tablets under tongue, up to 3 times per day.

Sudden onset: every 15 minutes until relieved, up to 6 doses.

Uses

INDICATIONS & USAGE SECTION

■ Helps temporarily relieves symptoms of:

■ restlessness ■ anxiousness ■ nervousness

■ irritability ■ apprehensiveness

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

CALM

STRESS RELIEF*

  • Anxiousness
  • Nervousness
  • Irritability
  • Non-Habit

Forming

50

QUICK-DISSOLVING TABLETS

CALMY0000T50CTNH1CALMY0000T50CTNH1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3331-1Calm50 in 1 BOTTLE, PLASTICTABLET505
54973-3331-1Calm1 in 1 CARTONTABLET15
54973-3331-2Calm4 in 1 POUCHTABLET45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3331CALM (TRIBASIC CALCIUM PHOSPHATE,FERROSOFERRIC PHOSPHATE,DIBASIC POTASSIUM PHOSPHATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE) TABLET [HYLAND'S INC.]5Legacy NDC, 3 package rows20250322_5e86783c-4154-5f46-e053-2991aa0abb3b.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-333154973-3331-1, 54973-3331-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
ACACIA5C5403N26OIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIB

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
CalmTRIBASIC CALCIUM PHOSPHATE,FERROSOFERRIC PHOSPHATE,DIBASIC POTASSIUM PHOSPHATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHyland's Inc.5e86783c-4154-5f46-e053-2991aa0abb3b2025-03-19WarningsExact identifier
ndc (package): 54973-3331-2
ndc (package): 54973-3331-1
ndc (product): 54973-3331
ndc11 (package): 54973333101
ndc11 (package): 54973333102
spl id: 30bb3426-d2de-9efa-e063-6294a90a4ccb
spl set id: 5e86783c-4154-5f46-e053-2991aa0abb3b

Reported adverse events (FAERS/openFDA)#

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