Family Wellness
- Product NDC
- 55319-108
- 11-digit product format
- 553190108
- Labeler code
- 55319
- Product ID
- 55319-108_40ab3bb4-cbc0-b9e1-e063-6294a90a5a0f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine 20%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- FAMILY DOLLAR SERVICES INC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-02-01
- Substance
- BENZOCAINE
- Active strength
- .2 g/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Family Wellness
- Brand name suffix
- Oral Pain Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | .2 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 238910 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 105d87d6-9147-43d4-e063-6394a90a57ee | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-108-14 | Family WellnessOral Pain Relief | 1 in 1 CARTON | GEL | 1 | 3 | |
| 55319-108-14 | Family WellnessOral Pain Relief | 14 g in 1 TUBE | GEL | 14 | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | af430cf4-f1b4-4b57-b8e3-87df96d655d3 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 2b089fec-cae3-4dc9-964d-d37f732a2f9f | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 6c137a93-4a34-4849-997f-bd0c572466ef | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | e8aa9709-e8f6-47a6-ab29-1fef2309786b | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 8c55b39c-8231-46a1-92ef-9fb4e3f40c1e | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9e82dc54-aeca-457f-b4b9-2f18cc269538 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 1a8f5964-770a-4d14-a7b6-18b5da9159b0 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722cdf3-7671-eb27-e053-2a95a90a09c4 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722bf24-ae85-54f6-e053-2995a90a1d35 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721864d-0950-8379-e053-2a95a90a3bcb | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | b0e5dc67-da7a-42ac-8657-e8e4da6914be | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721ff57-0111-4bbb-e053-2995a90a1a70 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 8129e871-5f31-4138-ae47-f8978fa6287f | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 0301c1bc-db48-4635-97f5-9eaef7ab9579 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | c0c88180-ccdc-4c48-b262-3ec20d4775d4 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | ba011795-6822-4fff-b9c8-5c91cf9972a7 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 462a5f09-131f-4dfa-a502-547c44e4a4a5 | 2025-01-16 | Warnings | M022 |
| Benzocaine | TOPICAL ANESTHETIC | Everpharm LLC | 2bc57111-0f15-b237-e063-6294a90a4471 | 2025-01-15 | Warnings | M022 |
| Kanka Triple Action | BENZOCAINE AND MENTHOL, UNSPECIFIED FORM | Blistex Inc. | 078fcdab-38a1-4a9a-bdd3-e17446591ea8 | 2025-01-09 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238910 | benzocaine 20 % Oral Gel | PSN | 105d87d6-9147-43d4-e063-6394a90a57ee | 3 |
| 238910 | benzocaine 0.2 MG/MG Oral Gel | SCD | 105d87d6-9147-43d4-e063-6394a90a57ee | 3 |
| 238910 | benzocaine 20 % (180-220 MG per 1 GM) Oral Gel | SY | 105d87d6-9147-43d4-e063-6394a90a57ee | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55319-108-14 | 55319010814 | 1 TUBE in 1 CARTON (55319-108-14) / 14 g in 1 TUBE | 1 tube | 2024-02-01 | No | No | Current |