Indications and uses
Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. Aids in prevention of dental cavities.
Early Bird Wintergreen and Peppermint
- Manufacturer
- Smiletwice, Inc.
- Effective date
- 2022-10-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-05-31 23:51:09
Label at a glance#
ProductEarly Bird Wintergreen and Peppermint
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure6 sections
Dosage and administration
Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. · Children under 12 years: consult a dentist or doctor.
Label contents#
Full prescribing information#
Active ingredients
Potassium Nitrate 5%
Sodium Fluoride 0.240% (0.15% w/v Fluoride ion)
Purpose
Antihypersensitivity
Anticavity
Uses
Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Aids in prevention of dental cavities.
Warnings
When using this product,
if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.
Stop use and ask a dentist
if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
Keep out of reach of children.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. · Children under 12 years: consult a dentist or doctor.
Inactive Ingredients
Water, Hydrated Silica, Sorbitol, Glycerin, Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Sodium Acorbyl Phosphate (Vitamin C), Retinyl Palmitate (Vitamin A), Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice (Aloe Vera), Xylitol, Sodium Saccharin, Sucralose, Lauryl Glucoside, Cellulose Gum, Titanium Dioxide, Sodium Benzoate, Citric Acid.
Package Labeling:
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | PSN | 6 |
| 1038929 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 6 |
| 1038929 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 6 |
| 1038929 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | SY | 6 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72164-001-00 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9d1e-d83d-e063-dadaa90ab31f | Early Bird Wintergreen and Peppermint Toothpaste |
| 72164-001-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9d1e-d83d-e063-dadaa90ab31f | Early Bird Wintergreen and Peppermint Toothpaste |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72164-001-00 | Early Bird Wintergreen and Peppermint | 96 g in 1 TUBE | PASTE | 96 | 6 | |
| 72164-001-00 | Early Bird Wintergreen and Peppermint | 2 in 1 BOX | PASTE | 2 | 6 | |
| 72164-001-01 | Early Bird Wintergreen and Peppermint | 96 g in 1 TUBE | PASTE | 96 | 6 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Early Bird Wintergreen and Peppermint
- POTASSIUM NITRATE, SODIUM FLUORIDE
- WATER
- HYDRATED SILICA
- SORBITOL
- GLYCERIN
- SODIUM TRIPOLYPHOSPHATE ANHYDROUS
- COCAMIDOPROPYL BETAINE
- METHYL SALICYLATE
- SODIUM ASCORBYL PHOSPHATE
- VITAMIN A PALMITATE
- TOCOPHEROL
- ALOE VERA LEAF
- XYLITOL
- SACCHARIN SODIUM
- SUCRALOSE
- LAURYL GLUCOSIDE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- TITANIUM DIOXIDE
- SODIUM BENZOATE
- CITRIC ACID MONOHYDRATE
- POTASSIUM NITRATE
- NITRATE ION
- SODIUM FLUORIDE
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72164-001 | 72164-001-01, 72164-001-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| ebe7cc38-e054-1d14-e053-2a95a90aad8f | 10743960-2a60-4a2f-a024-8e3b79b0d118 | 2022-10-25 | Warnings | ebe7cc38-e054-1d14-e053-2a95a90aad8f 10743960-2a60-4a2f-a024-8e3b79b0d118 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.