Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient Sodium Fluoride 0.24%
OTC - PURPOSE SECTION
Purpose Anticavity
HEB
- Manufacturer
- HEB | Lornamead Products
- Effective date
- 2026-01-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:52:30
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
Use Helps protect against caviites
Warnings
WARNINGS SECTION
Warnings
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Directions Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Do not swallow To minimize swallowing use a pea-sized amount in children under 6 Supervise childrens brushing until good habits are established Children under 2 years of age: consult a dentist or doctor.
Other Label Information
INACTIVE INGREDIENT SECTION
Inactive ingredients water, sorbitol, hydrated silica, glycerin, PEG-12, cellulose gum, flavor, titanium dioxide, sodium benzoate, sodium saccharin, cocamidopropyl betaine, red 40
STORAGE AND HANDLING SECTION
Other information Store in a cool dry place. Keep tube capped when not in use.
OTC - QUESTIONS SECTION
Questions or Comments? Call 1-877-777-2743
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 416783 | sodium fluoride 0.24 % Toothpaste | PSN | 7 |
| 416783 | sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 7 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste | SY | 7 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 7 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 7 |
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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37808-167-70 | HEBHEBuddy | 12 in 1 CASE | PASTE, DENTIFRICE | 12 | 7 | |
| 37808-167-70 | HEBHEBuddy | 119 g in 1 TUBE | PASTE, DENTIFRICE | 119 | 7 | |
| 37808-167-72 | HEBHEBuddy | 119 g in 1 TUBE | PASTE, DENTIFRICE | 119 | 7 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 1 | |
| COCAMIDOPROPYL BETAINE | INACTIVE INGREDIENT | 5OCF3O11KX | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HYDRATED SILICA | INACTIVE INGREDIENT | Y6O7T4G8P9 | 1 | |
| POLYETHYLENE GLYCOL 600 | INACTIVE INGREDIENT | NL4J9F21N9 | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
- HEB HEBuddy
- Fluoride
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37808-167 | 37808-167-70, 37808-167-72 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| COCAMIDOPROPYL BETAINE | 5OCF3O11KX | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient Sodium Fluoride 0.24%
OTC - PURPOSE SECTION
Purpose Anticavity
INDICATIONS & USAGE SECTION
Use Helps protect against caviites
WARNINGS SECTION
Warnings
DOSAGE & ADMINISTRATION SECTION
Directions Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Do not swallow To minimize swallowing use a pea-sized amount in children under 6 Supervise childrens brushing until good habits are established Children under 2 years of age: consult a dentist or doctor.
INACTIVE INGREDIENT SECTION
Inactive ingredients water, sorbitol, hydrated silica, glycerin, PEG-12, cellulose gum, flavor, titanium dioxide, sodium benzoate, sodium saccharin, cocamidopropyl betaine, red 40
STORAGE AND HANDLING SECTION
Other information Store in a cool dry place. Keep tube capped when not in use.
OTC - QUESTIONS SECTION
Questions or Comments? Call 1-877-777-2743
SPL UNCLASSIFIED SECTION
MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TX 78204 MADE IN USA
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 6 | 2025-08-08 | full-release | 2026-06-01 01:09:44 |