NBE Anbesol
- Product NDC
- 0363-0316
- 11-digit product format
- 003630316
- Labeler code
- 0363
- Product ID
- 0363-0316_441e7c47-f347-a262-e063-6394a90ae697
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- ORAL
- Labeler
- Walgreens
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-04-30
- Substance
- BENZOCAINE
- Active strength
- 20 g/100g
- 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
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0363-0316 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | ||
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0363-0316 | 0363-0316-69 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… |
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
- NBE Anbesol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 20 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| dd2a3125-32f8-5fff-e053-2995a90ac720 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0316-69 | NBE Anbesol | 1 in 1 CARTON | GEL | 1 | 6 | |
| 0363-0316-69 | NBE Anbesol | 9 g in 1 TUBE | GEL | 9 | 6 |
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. | 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 |
| Astra-dent Topical Anesthetic Gel | BENZOCAINE | Zag Usa Inc | 9315bd7c-44db-42c8-a9df-aaaa66153c17 | 2025-01-09 | Warnings | M022 |
| Astra-dent Topical Anesthetic Gel | BENZOCAINE | Zag Usa Inc | 56185c5f-6f6c-4976-bf18-540b076d90a6 | 2025-01-09 | Warnings | M022 |
| Astra-dent Topical Anesthetic Gel | BENZOCAINE | Zag Usa Inc | 88cadb9e-17ab-44bb-b4fe-fcfd6b733465 | 2025-01-09 | Warnings | M022 |
| Astra-dent Topical Anesthetic Gel | BENZOCAINE | Zag Usa Inc | f71b0ab5-0605-4807-b835-903e19aaf2a8 | 2025-01-09 | Warnings | M022 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-0316-69 | 00363031669 | 1 TUBE in 1 CARTON (0363-0316-69) / 9 g in 1 TUBE | 1 tube | 2022-06-22 | 0000-00-00 | No | No | Current |