FDA.reportPublic FDA data

CALC PHOS

Manufacturer
Hyland's Inc.
Effective date
2022-12-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:18:47

Label at a glance#

ProductCALC PHOS
Active ingredientCALCIUM PHOSPHATE
Label structure7 sections

Dosage and administration

Adults & Children ages 6 - 12: 4 tablets. Children ages 2 - 6: 2 tablets. Dissolve under tongue 3 times a day. Use more frequently (every 15 minutes for up to 8 doses) with acute conditions.

Label contents#

Full prescribing information#

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults & Children ages 6 - 12:

4 tablets.

Children ages 2 - 6:

2 tablets. Dissolve under tongue

3 times a day. Use more frequently

(every 15 minutes for up to 8 doses)

with acute conditions.

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Temporarily relieves symptoms of gum or tooth sensitivity.

FORMULA

OTC - ACTIVE INGREDIENT SECTION

Calcarea Phosphorica 6X HPUS

INACTIVE INGREDIENT SECTION

in a base of Acacia Gum, Lactose N.F.

SPL UNCLASSIFIED SECTION

"HPUS" indicates that the active

ingredients are in the official

Homeopathic Pharmacopœia of the

United States.

WARNINGS

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, ask a doctor before use if pregnant or breast feeding.

OTC - DO NOT USE SECTION

Do not use more than directed.

Consult a physician if

OTC - ASK DOCTOR SECTION

  • symptoms persist for more than 72 hours or worsen.
  • swelling increases, rash or fever develops.
  • irritation,pain or rednes persists or worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children.

OTC - DO NOT USE SECTION

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

SPL UNCLASSIFIED SECTION

In case of an emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland's may be contacted for emergency information about our products 24 hours, a day 7 days per week at (800) 624-9659.

QUESTIONS?

OTC - QUESTIONS SECTION

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

NDC 54973-2043-01

Hyland's®

#2

Calc Phos 6X

Gum & Tooth

Sensitivity*

500 TABLETS

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-2043CALC PHOS (CALCIUM PHOSPHATE) TABLET [HYLAND'S INC.]6Legacy NDC20221208_16079e84-3ff2-4e3a-9fe2-69fb625c00eb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM PHOSPHATEACTIVE INGREDIENT97Z1WI3NDX2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB2
ACACIAINACTIVE INGREDIENT5C5403N26O2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G2

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
54973-204354973-2043-1, 54973-2043-2, 54973-2043-3

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
LACTOSEJ2B2A4N98GIACT
ACACIA5C5403N26OIACT
CALCIUM PHOSPHATE97Z1WI3NDXACTIB

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 · 55 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GGRANULE, FOR SUSPENSION / ORAL512.5 mg/5mlExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCREAM / VAGINAL3 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAMUSCULAR203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, CHEWABLE / ORAL1412 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, FILM COATED / ORAL0.14 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSUPPOSITORY / VAGINALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, COATED / ORAL332.05 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / BUCCAL296.7 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, EXTENDED RELEASE / ORAL34.4 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OSUSPENSION / ORAL2 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GOINTMENT / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OSYRUP / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EFFERVESCENT / ORAL96.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED, EXTENDED RELEASE / ORAL620 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSOLUTION / ORAL1682 mg/15mlExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / ORAL530 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OSUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EXTENDED RELEASE / ORAL400 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSOLUTION / RECTAL8 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, SOLUTION / INTRAVENOUS0.45 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY193.8 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, CHEWABLE / ORAL121 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OPOWDER / ORAL800 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GFILM, EXTENDED RELEASE / TRANSDERMAL675 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, DELAYED RELEASE / ORAL231.84 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED PELLETS / ORAL135.2 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER / RESPIRATORY (INHALATION)90 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / RESPIRATORY (INHALATION)44.4 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, DELAYED RELEASE / ORAL160 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OCAPSULE / ORAL20 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCONCENTRATE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OLOZENGE / ORAL108 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OGUM, CHEWING / BUCCAL280 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / SUBLINGUAL352 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OPOWDER, FOR SUSPENSION / ORAL7386 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, COATED / ORAL156 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / SUBLINGUAL9.1 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER / VAGINAL430 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAVENOUS203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / BUCCAL9.1 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / RECTAL20 mgExact identifier — unii candidate
36 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
41b2eeef-3b31-69e2-e063-6294a90a7b9216079e84-3ff2-4e3a-9fe2-69fb625c00eb2025-10-21WarningsExact identifier
spl set id: 16079e84-3ff2-4e3a-9fe2-69fb625c00eb

Reported adverse events (FAERS/openFDA)#

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