Orajel Fluoride
- Manufacturer
- Church & Dwight Co., Inc.
- Effective date
- 2023-01-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:40:46
Label at a glance#
ProductOrajel Fluoride
Active ingredientSODIUM FLUORIDE
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Sodium Fluoride (0.24%)
OTC - PURPOSE SECTION
Anticavity Toothpaste
INDICATIONS & USAGE SECTION
Use aids in the prevention of dental decay
WARNINGS SECTION
Keep out of reach of children under 6 years of age.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions:
twist off cap and remove foil seal
do not swallow
supervise children as necessary until capable of using without supervision
adults and children 2 years and older - brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 years - instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years - ask a dentist or physician
INACTIVE INGREDIENT SECTION
sorbitol, water, hydrated silica, PEG-8, flavor, cellulose gum, sodium saccharin, sodium lauryl sulfate, blue 1
OTC - QUESTIONS SECTION
Questions or comments Call us at 800 952 5080 Monday through Friday 9 - 5 ET or visit our website at www orajel com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Berry Divine
Orajel ™
Anticavity
Fluoride
Toothpaste
Shimmer and Shine
NET WT. 4.2 OZ (119g)
Nickelodeon
Products#
Every source-derived product name is available through these pages.
- Orajel Fluoride
- Sodium Fluoride
- FLUORIDE ION
- SODIUM LAURYL SULFATE
- SACCHARIN SODIUM
- FD&C BLUE NO. 1
- SORBITOL
- HYDRATED SILICA
- POLYETHYLENE GLYCOL 400
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10237-763 | 10237-763-42 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| SORBITOL | 506T60A25R | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED | K679OBS311 | IACT |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| bf8cdcaa-164a-49b0-a338-39b1b2c4864c | 438ae02a-dcf4-38c9-e054-00144ff8d46c | 2024-07-02 | Warnings | 438ae02a-dcf4-38c9-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.