Baby Orajel Naturals

Manufacturer
Church & Dwight Co., Inc. | Church & Dwight Canada Corp.
Effective date
2015-12-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:29:26

Label at a glance#

ProductBaby Orajel Naturals
Active ingredientPASSIFLORA INCARNATA FLOWERING TOP, TURPENTINE OIL, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA RECUTITA, ARABICA COFFEE BEAN, TRIBASIC CALCIUM PHOSPHATE
Label structure9 sections

Dosage and administration

Dissolve 2-3 tablets (1 at a time) under baby's tongue or in a teaspoon of water prior to being given to baby. Can give 2-3 tablets every hour up to 4 times per day or as recommended by a licensed healthcare professional. Other information Do not use if seal is cut or torn prior to opening Store in dry environment Leave SorbiCap desiccant in bottle

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Calcarea carbonica, Calcarea phosphorica, Chamomilla, Coffea cruda, Passiflora incarnata (Passion Flower), Terebinthina

OTC - PURPOSE SECTION

Calcarea carbonica - Delayed or slow teething

Calcarea phosphorica - Difficult teething, dentition

Chamomilla - Irritibility, crying and whining

Coffea cruda - Occassional sleeplessness, restlessness

Passiflora incarnata - Restlessness

Terebinthia - Irritability

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves the multiple symptoms of dentition, restlessness and wakeful irritability due to cutting teeth. For children under 2, consult your physician or healthcare provider.

WARNINGS SECTION

WARNINGS

Stop use and ask a doctor if symptoms persist for more than 7 days, if irritation persists of if inflammation, fever or infection develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Dissolve 2-3 tablets (1 at a time) under baby's tongue or in a teaspoon of water prior to being given to baby. Can give 2-3 tablets every hour up to 4 times per day or as recommended by a licensed healthcare professional.

Other information

Do not use if seal is cut or torn prior to opening

Store in dry environment

Leave SorbiCap desiccant in bottle

INACTIVE INGREDIENT SECTION

Cellulose, lactose, magnesium stearate, mannitol, starch

OTC - QUESTIONS SECTION

Questions or comments. Call us at 800 952 5080 or visit www orajel com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 TEETHING BRAND

recommended by Pediatricians

La marca numero 1

para la denticion

mas recomendada

por pediatras

Fast Dissolving

Baby

Orajel

Naturals

for Teething Pain Relief

Para el alivio del dolor de las denticion

HOMEOPATHIC Homeopatico

MULTI-SYMPTOM TEETHING RELIEF

Multiples sintomas

  • Teething Discomfort Molestia de la denticion
  • Restlessness & Irritability Inquietud e irritabilidad
  • First Tooth Development Aparicion de los primeros dientes

ORAL PAIN RELIEVER FOR TEETHING

Analgesico Oral Para La Denticion

135 TABLETS

Tabletas

BOJFC-32371-06

BOJFC-32371-06BOJFC-32371-06

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
10237-90810237-908-12

Ingredients#

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

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

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
26545e80-8c0d-2424-e054-00144ff88e8826545e80-8c0c-2424-e054-00144ff88e882015-12-07WarningsExact identifier
spl id: 26545e80-8c0d-2424-e054-00144ff88e88
spl set id: 26545e80-8c0c-2424-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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