Benzocaine
- Product NDC
- 84415-044
- 11-digit product format
- 844150044
- Labeler code
- 84415
- Product ID
- 84415-044_2bc582da-83f3-1644-e063-6294a90a8968
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Topical Anesthetic
- Dosage form
- SPRAY
- Route
- DENTAL; PERIODONTAL
- Labeler
- Everpharm LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-15
- Substance
- BENZOCAINE
- Active strength
- 200 mg/mL
- 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
- Benzocaine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 200 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 360348 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2bc57111-0f15-b237-e063-6294a90a4471 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84415-044-01 | Benzocaine | 1 in 1 POUCH | SPRAY | 1 | 1 | |
| 84415-044-01 | Benzocaine | 25 in 1 PACKAGE | SPRAY | 25 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 84415-044-01 | EA - Each | 84415-044 | fe963d92-91de-4a01-8f84-dbc954d24cb7 | 1 | 2025-05-14 |
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 |
|---|---|---|---|---|---|---|
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | WinCo Foods, LLC | 9417b340-942b-48bf-bbfd-4cd5154082b9 | 2025-02-12 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | b291811f-8fac-45e2-a9a2-b3ecc0813d0d | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | fea30599-5e3b-4163-9660-d41b3fcee143 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 3be68966-199c-481e-8b9e-e994c41fd96a | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | ccdee0cc-2bc9-4165-a411-02f4f900d86a | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 0ca2b042-ea2c-4cbe-ae68-5a72a6bfa0b7 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 69c4dd1b-a0db-4495-bfc3-faffdfdf59bf | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | d5ef3e65-35e8-4323-9f33-3076b561e105 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 746df21c-e92e-4a71-b1c6-baf99785a43e | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 2345e614-c7b6-448c-8e07-31700bade91c | 2025-01-29 | Warnings | M022 |
| UltraCare Anesthetic Gel | BENZOCAINE | The Belport Company, Inc. DBA Gingi-Pak | 142062ca-6f8f-78d2-e063-6294a90a19d8 | 2025-01-29 | Warnings, Adverse reactions | M022 |
| CHLORASEPTIC MAX | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | edd12a2d-aa27-4f15-9ce6-862e4b6144c4 | 2025-01-23 | Warnings | M022 |
| meijer Sensitive FRESH MINT | POTASSIUM NITRATE, SODIUM FLUORIDE | Meijer, Inc. | bea36d55-1a5d-40c0-b422-92fb36043ee6 | 2025-01-23 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 159d412c-6d1a-45d4-88c0-8c93960f946e | 2025-01-21 | Warnings | M022 |
| SEACALL Mouthwash | MOUTHWASH | Guangdong Quadrant Ecological Technology Co., Ltd. | 2c1a7eed-6a7c-eeb2-e063-6394a90aafcc | 2025-01-19 | Warnings | M022 |
| BENZOCAINE Raspberry | BENZOCAINE | Darby Dental Supply, LLC | dd805400-26c5-4c18-ade2-821298233f9b | 2025-01-17 | Warnings | M022 |
| KAYLAAN | ZERO WASTE REFILL FOR TOOTHPASTE | Kaylaan LLC | c68fd8c7-7ec3-cc3f-e053-2995a90a4395 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | d22f7776-1b3c-4744-bcfe-8d9597218d73 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9c6a26e8-1253-49f7-9ce2-45c0d39f05c5 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 48178733-7433-41ec-b178-1314e0edab1a | 2025-01-16 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 360348 | benzocaine 20 % Mucosal Spray | PSN | 2bc57111-0f15-b237-e063-6294a90a4471 | 1 |
| 360348 | benzocaine 200 MG/ML Mucosal Spray | SCD | 2bc57111-0f15-b237-e063-6294a90a4471 | 1 |
| 360348 | benzocaine 20 % Mucosal Spray | SY | 2bc57111-0f15-b237-e063-6294a90a4471 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84415-044-01 | 84415004401 | 25 POUCH in 1 PACKAGE (84415-044-01) / 1 APPLICATOR in 1 POUCH / .5 mL in 1 APPLICATOR | 25 pouch | 2025-01-15 | No | No | Current |