ORAL PAIN RELIEF
- Product NDC
- 52000-443
- 11-digit product format
- 520000443
- Labeler code
- 52000
- Product ID
- 52000-443_804b78cd-d8a1-4548-807c-75bd7c52009d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- ORAL
- Labeler
- Universal Distribution Center LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-01-20
- 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
- 2027-12-31
- 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
- ORAL PAIN RELIEF
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 20 g/100g |
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 |
|---|---|
| e276ba37-46fb-4ed9-9ee1-c08a2a89704a | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52000-443-04 | ORAL PAIN RELIEF | 1 in 1 BOX | GEL | 1 | 1 | |
| 52000-443-04 | ORAL PAIN RELIEF | 11.9 g in 1 TUBE | GEL | 11.9 | 1 |
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 |
|---|---|---|---|---|---|---|
| Parodontax Active Gum Health Clear Mint | CETYLPYRIDINIUM CHLORIDE | Haleon US Holdings LLC | 444f931d-5e38-4cda-97ba-98aa0b5fe4f6 | 2025-05-08 | Warnings | M022 |
| Listerine Clinical Solutions Gum Health Icy Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 06e1122b-1100-43c0-e063-6394a90a2e78 | 2025-04-22 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Strategic Sourcing Services LLC | 5260258a-bb1e-43d6-bce1-70a38778a64a | 2025-04-14 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | TARGET Corporation | 93d0bb3a-51d3-44c8-8fb7-bdb82adfbb65 | 2025-04-14 | Warnings | M022 |
| Listerine Ultraclean Antiseptic Cool Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | ee467ec4-bd5e-644a-e053-2a95a90ac273 | 2025-04-10 | Warnings | M022 |
| Mouthwash | MENTHOL, METHYL SALICYLATE, THYMOL | Orazen Inc | 873c43df-1d46-359b-e053-2a91aa0a4319 | 2025-04-07 | Warnings | M022 |
| Sensodyne Complete Protection Extra Fresh | STANNOUS FLUORIDE | Haleon US Holdings LLC | e3cc3146-8aed-4f6b-a252-e379418c2b8d | 2025-03-26 | Warnings | M022 |
| Listerine Freshburst Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | ee1e1df9-74c6-d24b-e053-2a95a90a43d3 | 2025-03-04 | Warnings | M022 |
| Listerine Cool Mint Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | edb9e374-4dba-5823-e053-2a95a90a3da5 | 2025-03-03 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Good Sense (Geiss, Destin & Dunn, Inc.) | cfe9be26-e4a4-413c-a602-2f5948e3bb7a | 2025-03-03 | Warnings | M022 |
| LISTERINE Original Antiseptic | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Kenvue Brands LLC | 78e2e172-09a4-4bf1-9871-d099c49087be | 2025-02-28 | Warnings | M022 |
| WHITE GLO CHARCOAL SENSITIVE | POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE | WHITE GLO USA INC | a5edb7fd-c637-5447-e053-2995a90a5a6f | 2025-02-26 | Warnings | M022 |
| Glorysmile Toothpaste. | GLORYSMILE TOOTHPASTE. | Jiangxi Dentalbright Technology Co., Ltd | 2ef48156-904d-e42a-e063-6394a90a3cd0 | 2025-02-25 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Walgreens | c4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa | 2025-02-21 | Warnings | M022 |
| Sheffield Pain Relief | BENZOCAINE | Sheffield Pharmaceuticals LLC | e21abfdd-373d-42af-9535-fe1571382a65 | 2025-02-19 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Whole Foods Market | a2bb142e-8cbe-481e-bf4f-810ca6d14591 | 2025-02-12 | Warnings | M022 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238910 | benzocaine 20 % Oral Gel | PSN | e276ba37-46fb-4ed9-9ee1-c08a2a89704a | 1 |
| 238910 | benzocaine 0.2 MG/MG Oral Gel | SCD | e276ba37-46fb-4ed9-9ee1-c08a2a89704a | 1 |
| 238910 | benzocaine 20 % (180-220 MG per 1 GM) Oral Gel | SY | e276ba37-46fb-4ed9-9ee1-c08a2a89704a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52000-443-04 | 52000044304 | 1 TUBE in 1 BOX (52000-443-04) / 11.9 g in 1 TUBE | 1 tube | 2026-01-20 | No | No | Current |