Over-the-counter drug · OTC MONOGRAPH DRUG
Oral Pain Relief (Benzocaine) NDC 52000-443
Benzocaine 20 g/100g · Gel · Oral · Universal Distribution Center LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52000-443-04 | 5200004430452000044304 | 1 TUBE in 1 BOX (52000-443-04) / 11.9 g in 1 TUBEMarketed from Jan 20, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Oral Pain Relief
- Generic name (nonproprietary)
- benzocaine
- Active ingredients
- Benzocaine — 20 g/100g
- Dosage form
- Gel
- Route
- Oral
- Labeler
- Universal Distribution Center LLCNDC labeler code 52000
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)
- Identifiers
- Product ID 52000-443_804b78cd-d8a1-4548-807c-75bd7c52009dSPL ID 804b78cd-d8a1-4548-807c-75bd7c52009dSPL set ID e276ba37-46fb-4ed9-9ee1-c08a2a89704aRxCUI 238910UNII U3RSY48JW5
- Pharmacologic class
- Standardized Chemical Allergen
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N452000044304followed by a unit qualifier and the quantityPackage 52000-0443-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses • for the temporary relief of pain due to toothaches • to help protect against infection in minor oral irritation
Excerpt only. Read the full label for complete information.
About NDC 52000-443
- What is NDC 52000-443?
- 52000-443 is the product NDC for Oral Pain Relief (benzocaine), Benzocaine 20 g/100g gel, listed with the FDA by Universal Distribution Center LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oral Pain Relief (Benzocaine).
- What is the active ingredient?
- Benzocaine.
- Who is the labeler?
- Universal Distribution Center LLC, NDC labeler code 52000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oral Pain Relief?
- 4 other product NDCs are listed under this name. See all Oral Pain Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oral Pain Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oral Pain Reliefbenzocaine | Benzocaine 20 g/100g | GelOral | Nantong Health & Beyond Hygienic Products Inc. | 43473-100 | 43473-0100-04 |
| Oral Pain Reliefbenzocaine and benzalkonium chloride | Benzocaine .2 g/g; Benzalkonium chloride .01 g/g | GelTopical | Universal Distribution Center LLC | 52000-060 | 52000-0060-02 |
| Oral pain reliefbenzocaine | Benzocaine .2 g/g | GelOral | ALAINA HEALTHCARE PRIVATE LIMITED | 73492-717 | 73492-0717-50 |
| Oral Pain Reliefbenzocaine | Benzocaine 200 mg/g | GelOral | GERI-CARE PHARMACEUTICAL CORP | 57896-139 | 57896-0139-05 |
Other NDCs under M 022
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-1820 |
| Organic Peppermint Herb Throat Dropsmenthol | Menthol 1.9 mg/1 | LozengeOral | Ricola USA Inc. | 63667-010 |
| Equate Sculpted White TP Equate Sculpted White TPsodium fluoride | Sodium fluoride .15 g/100g | Paste, DentifriceOral | Walmart | 79903-282 |
| Ki No Sincalcium carbonate | Calcium carbonate 55 mg/500mg | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-322 |
| R B onephosphatidylserine, zinc oxide | Zinc oxide 6.38 mg/1100mg + 2 more ingredients | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-140 |
| Sensodynepotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0550 |
| parodontaxstannous fluoride | Stannous fluoride 1.1 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0598 |
| CVS Health Sensitive Enamel Repairsodium fluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceOral | CVS | 51316-169 |
| Alzh Lphosphatidylserine, magnesium oxide | Phosphatidyl serine 214.43 mg/450mg + 2 more ingredients | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-230 |
| Topicalebenzocaine | Benzocaine 180 mg/g | OintmentOral | Medical Products Laboratories, Inc. | 10733-162 |
| Walgreens Maximum Strengthbenzocaine | Benzocaine 20 g/100g | Paste, DentifriceTopical | Walgreens | 0363-5337 |
| Walgreens Maximum Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Walgreens | 0363-5820 |
| Dem Zerophosphatidylserine, magnesium oxide | Phosphatidyl serine 214.43 mg/450mg + 2 more ingredients | TabletOral | NPG Bio Pharmaceuticals Co.,Ltd. | 84540-240 |
| Benzoin Tincturebenzoin resin | Benzoin resin 1000 mg/mL | LiquidTopical | 116956644 | 70677-1200 |
| Rite Aid Maximum Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Rite Aid | 11822-0345 |
| Chloraseptic Sore Throat Citrusphenol | Phenol 1.4 g/100mL | SprayOral | Prestige Brands Holdings, Inc. | 67172-112 |
| Sore Throat Relief Cherry Flavorphenol | Phenol 1.4 g/100mL | SprayOral | Cardinal Health | 70000-0458 |
| HurriCaine Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0293 |
| Rite Aid Professional Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Rite Aid | 11822-5340 |
| Benzocaine 20% | Benzocaine 200 mg/mL | SolutionTopical | PAI Holdings, LLC dba PAI Pharma | 0121-1077 |
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