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 |
|---|---|---|---|---|---|---|
| Giltuss Bucalsep | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Gil Pharmaceutical Corp | 85053391-8d71-ab4f-e053-2991aa0a7e08 | 2025-10-09 | Warnings | M022 |
| Listerine Gum Therapy Mouthwash Glacier Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 40a0bdf3-1698-1449-e063-6394a90ab13d | 2025-10-08 | Warnings | M022 |
| Kalaya Breath Refresh | MOUTHWASH | Avaria Health and Beauty Corp | 750e99ff-72e4-3c2f-e053-2a91aa0ad5a0 | 2025-10-08 | Warnings | M022 |
| Trader Joes | SODIUM FLUORIDE 0.24% AND POTASSIUM NITRATE 5% | TRADER JOE'S COMPANY | 159abeba-6da2-2643-e063-6394a90a730d | 2025-10-08 | Warnings | M022 |
| Family Wellness Oral Pain Relief | BENZOCAINE 20% | FAMILY DOLLAR SERVICES INC | 105d87d6-9147-43d4-e063-6394a90a57ee | 2025-10-08 | Warnings | M022 |
| Equate Glistening Mint | SODIUM FLUORIDE | Walmart Inc. | 39ff21ee-a362-014e-e063-6294a90a0d91 | 2025-10-03 | Warnings | M022 |
| Mouth Sore Relief Professional Strength | BENZOCAINE | CVS Pharmacy | 1b7209f6-8368-47fa-8df2-b049613b8c1b | 2025-09-30 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Family Dollar (FAMILY WELLNESS) | 9db73da2-5b70-41e6-bcf9-caa7f1142024 | 2025-09-29 | Warnings | M022 |
| Esunix Oral Bacteriostatic Liquid | CETYLPYRIDINIUM CHLORIDE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f47d7e1-b6ae-efd1-e063-6394a90a4602 | 2025-09-27 | Warnings | M022 |
| Chloraseptic Sore Throat Cherry | PHENOL | Prestige Brands Holdings, Inc. | d5d62f7a-8f92-4d42-a2fb-691f896f72fc | 2025-09-26 | Warnings | M022 |
| Giltuss Bucalsep | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Dextrum Laboratories Inc. | 3fa233dc-156c-1e95-e063-6294a90a8bbd | 2025-09-25 | Warnings | M022 |
| Finafta MultiOral | BENZOCAINE | Dextrum Laboratories Inc. | cb027ab8-4175-4cc0-a73e-991dfb113df9 | 2025-09-23 | Warnings | M022 |
| 4-in-1 Teeth Care Pens | 4-IN-1 TEETH CARE PENS | Jiangxi Dentalbright Technology Co., Ltd | 3f872924-0c44-267b-e063-6394a90a1a67 | 2025-09-23 | Warnings | M022 |
| Dental Relief | BENZOCAINE | Cintas Corporation | 0f40f775-797e-43cf-88c9-00eea666494f | 2025-09-23 | Warnings | M022 |
| Seavue Anti-caries Gel | SODIUM FLUORIDE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f4c6086-b96d-8fa4-e063-6294a90ad800 | 2025-09-21 | Warnings | M022 |
| Seavue Dental Desensitizer | POTASSIUM NITRATE AND SODIUM FLUORIDE DENTIFRICE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f47f399-1a14-5264-e063-6394a90aeb1c | 2025-09-20 | Warnings | M022 |
| Povi-One | POVIDONE-IODINE 10% TOPICAL | Elevate Oral Care | 27c29a33-d1cc-d72f-e063-6394a90a4d45 | 2025-09-19 | Warnings | M022 |
| Povi-One | POVIDONE-IODINE 10% TOPICAL | Elevate Oral Care | f5252b4f-5e14-509e-e053-2995a90a6db8 | 2025-09-18 | Warnings | M022 |
| Patterson Dental Topical Anesthetic | BENZOCAINE | Patterson Dental | 3f199947-bf25-914b-e063-6394a90a8a6f | 2025-09-18 | Warnings | M022 |
| Patterson Dental Topical Anesthetic | BENZOCAINE | Patterson Dental | 3f199947-bf28-914b-e063-6394a90a8a6f | 2025-09-18 | 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 |