FDA.reportPublic FDA data

Calc Phos

Manufacturer
Hyland's Inc.
Effective date
2022-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:18:48

Label at a glance#

ProductCalc Phos
Active ingredientTRIBASIC CALCIUM PHOSPHATE
Label structure8 sections

Indications and uses

■ Temporarily relieves: ■ gum or tooth sensitivity ■ teething pain

Dosage and administration

■ Use as directed. ■ Adults and children 6 years and over: Dissolve 1 tablet under tongue 3 times per day.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Gum & Tooth Sensitivity, Teething Pain

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
Calcarea Phosphorica 6X HPUSgum and tooth sensitivity, teething pain

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves:
■ gum or tooth sensitivity ■ teething pain

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ symptoms persist for more than 7 days or worsen. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. ■ swelling increases; nasal congestion, rash or fever is present or develops. ■ irritation, pain or redness persists or worsens.

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 6 years and over: Dissolve 1 tablet under tongue 3 times per day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

PACKAGE LABEL - 2 x 50 CT TABLET BOTTLES CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

CELL SALT

#2

CALC PHOS 6X

Gum & Tooth
Sensitivity*
Teething Pain*

2 x 50 CT BOTTLES

QUICK-DISSOLVING SINGLE TABLET DOSES

HOMEOPATHIC

CartonCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4073CALC PHOS (TRIBASIC CALCIUM PHOSPHATE) TABLET [HYLAND'S INC.]2Legacy NDC20221208_d35a1b87-4d0a-fcff-e053-2995a90a231f.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-407354973-4073-1, 54973-4073-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
ACACIA5C5403N26OIACT
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
41b2fb87-ba74-f195-e063-6394a90a42f9d35a1b87-4d0a-fcff-e053-2995a90a231f2025-10-21WarningsExact identifier
spl set id: d35a1b87-4d0a-fcff-e053-2995a90a231f

Reported adverse events (FAERS/openFDA)#

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