Baby Orajel Naturals Twin Pack
- Manufacturer
- Church & Dwight Co., Inc.
- Effective date
- 2016-11-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:21:38
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Daytime:
Calcarea phosporica, 12x HPUS
Chamomilla, 6x HPUS
Coffea cruda, 6x HPUS
Nightime:
Calcarea phosporica, 12x HPUS
Chamomilla, 6x HPUS
Coffea cruda, 6s HPUS
Passiflora incarnata (Passion Flower), 6x HPUS
OTC - PURPOSE SECTION
Supports dentition
Irratability
Restlessness
INDICATIONS & USAGE SECTION
Uses temporarily relieves the symptoms for simple restlessness and wakeful irritability due to cutting teeth, for children under 4 months of age, consult with your physician or healthcare provider
WARNINGS SECTION
Stop use and ask a physician if symptoms persist for more than 7 days or if irritatino persists; inflammation, fever or infection develops
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
wash hands
cut open tip of tube on score mark
use your fingertip or cotton applicator to apply a small, pea-size amount of Baby Orajel Naturals and spread over the gums
apply to the affected area up to 6 times daily or as directed by a physician or healthcare provide
for infants under 4 months of age, ask a physician or healthcare provider
Other Information
Do not use if tube tip is cut prior to opening
INACTIVE INGREDIENT SECTION
Daytime:
glycerin, hydroxyethylcellulose, potassium sorbate, sodium benzoate, sorbic acid, water
Nighttime:
flavor, glycerin, hydroxyethylcellulose, potassium sorbate, sodium benzoate, sorbic acid, water
OTC - QUESTIONS SECTION
Questions or comments call us at 800 952 5080 Monday through Friday 9 to 5 or visit our website at www orajel com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
#1 Teething Brand
recommended by Pediatricians
Marca numero 1 recomendada
por Pediatras para la denticion
Baby
ORAJEL™
Naturals
for Teething Pain Relief
Para el alivio del dolor de la denticion
2 gels
Homeopathic Homeopaticas
Daytime & Nighttime
Twin Pack
Paraben-Free Benzocaine-Free Belladonna-Free Dye-Free
Sin parabeno Sin benzocaina Sin Belladona Sin tintes
HELPS RELIEVE TEETHING DISCOMFORT Ayuda A Aliviar El Malestar De La Denticion
2 TUBES NET WT 0.18 OZ (5.1g) EACH
Horizontal Pack 00005
Vertical 00007
Products#
Every source-derived product name is available through these pages.
- Baby Orajel Naturals Twin Pack
- Orajel Naturals
- TRIBASIC CALCIUM PHOSPHATE
- CALCIUM CATION
- MATRICARIA RECUTITA
- GLYCERIN
- HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
- PASSIFLORA INCARNATA FLOWER
- SODIUM BENZOATE
- WATER
- POTASSIUM SORBATE
- SORBIC ACID
- ARABICA COFFEE BEAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10237-757 | 10237-757-18, 10237-757-19 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | ACTIM |
| MATRICARIA RECUTITA | G0R4UBI2ZZ | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) | R33S7TK2EP | IACT |
| PASSIFLORA INCARNATA FLOWER | K8F3G29S6Z | ACTIB |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| WATER | 059QF0KO0R | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| ARABICA COFFEE BEAN | 3SW678MX72 | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 40f4cc70-674b-44ef-e054-00144ff88e88 | 40f4cc70-674a-44ef-e054-00144ff88e88 | 2016-11-10 | Warnings | 40f4cc70-674b-44ef-e054-00144ff88e88 40f4cc70-674a-44ef-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

