FDA.reportPublic FDA data

Baby Oral Pain Relief Drops

Manufacturer
Hyland's | Standard Homeopathic Company | Applied Laboratories, Inc.
Effective date
2019-01-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:33:14

Label at a glance#

ProductBaby Oral Pain Relief Drops
Active ingredientARNICA MONTANA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA
Label structure7 sections

Indications and uses

Temporarily relieves the symptoms of: gum sensitivity,swelling or soreness of gums, oral pain or discomfort

Dosage and administration

Measure only with the dosing dropper provided. Do not use dropper with other products. On dosing dropper, mL= milliliter. Fill to prescribed level and dispense liquid slowly into baby’s mouth, toward inner cheek. For best results, clean dropper after each use with water. Newborns and infants under 2 years of age (or weight under 24 lbs.) 0.3 mL every 15 minutes for up to 8 doses, then every 2 hours until relieved....

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 30X HPUS

Calcarea Carbonica 12X HPUS

Calcarea Phosphorica 12X HPUS

Chamomilla 12X HPUS

Coffea Cruda 6X HPUS

Ferrum Phosphoricum 12X HPUS

“HPUS” indicates that the active ingredients are in the official Homeopathic

Pharmacopœia of the United States.

Purpose

OTC - PURPOSE SECTION

Arnica Montana 30X HPUS...............................sore, sensitive or swelling gums

Calcarea Carbonica 12X HPUS..........................sore, sensitive or swelling gums

Calcarea Phosphorica 12X HPUS..................sensitive, swelling gums, oral pain

Chamomilla 12X HPUS.....................................sore, sensitive or swelling gums

Coffea Cruda 6X HPUS..........................................................oral pain, irritability

Ferrum Phosphoricum 12X HPUS......................oral discomfort, swelling gums

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of: gum sensitivity,swelling or soreness of gums, oral pain or discomfort

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • more than directed.
  • if your child has a known allergy to any ingredient in this product.

Consult a physician if

SPL UNCLASSIFIED SECTION

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Do not use if imprinted tamper-evident foil inner seal is broken or missing.

OTC - DO NOT USE SECTION

The inner packaged bottle is child-resistant.

SPL UNCLASSIFIED SECTION

In case of emergency

SPL UNCLASSIFIED SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Measure only with the dosing dropper provided.
  • Do not use dropper with other products.
  • On dosing dropper, mL= milliliter.
  • Fill to prescribed level and dispense liquid slowly into baby’s mouth, toward inner cheek.
  • For best results, clean dropper after each use with water.

Newborns and infants under 2 years

of age (or weight under 24 lbs.)

0.3 mL every 15 minutes for up to 8 doses,

then every 2 hours until relieved.

Children over 2 years of age

(or weight over 24 lbs.)

0.6 mL every 15 minutes for up to 8 doses,

then every 2 hours until relieved.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerine, Potassium Sorbate, Purified Water, Sodium Citrate.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659.

Principal Display Panel - 1 FL. OZ. (29.6 mL) Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New!

NDC 54973-339-1

HOMEOPATHIC

NATURAL

RELIEF

SINCE 1903

Hyland's

baby

Oral Pain

Relief Drops*

RELIEF OF PAIN,

IRRITABILITY AND SWELLING

DUE TO ORAL DISCONFORT

► No Belladonna, Benzocaine,

Artificial Flavors, Dyes or Parabens

1 FL. OZ (29.6 mL) CONTAINS 0.1% ALCOHOL

cartoncarton

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-339154973-3391-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB

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
d42841a0-bed6-5fa0-e053-2a95a90afa407ffe2d76-254a-1406-e053-2991aa0afb612021-12-27WarningsExact identifier
spl set id: 7ffe2d76-254a-1406-e053-2991aa0afb61

Reported adverse events (FAERS/openFDA)#

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