Over-the-counter drug · OTC MONOGRAPH DRUG
Benzocaine (Topical anesthetic) NDC 84415-044
Benzocaine 200 mg/mL · Spray · Dental, Periodontal · Everpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84415-044-01 | 8441500440184415004401 | 25 POUCH in 1 PACKAGE (84415-044-01) / 1 APPLICATOR in 1 POUCH / .5 mL in 1 APPLICATORMarketed from Jan 15, 2025 |
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)
- Benzocaine
- Generic name (nonproprietary)
- topical anesthetic
- Active ingredients
- Benzocaine — 200 mg/mL
- Dosage form
- Spray
- Route
- Dental, Periodontal
- Labeler
- Everpharm LLCNDC labeler code 84415
- 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 84415-044_2bc582da-83f3-1644-e063-6294a90a8968SPL ID 2bc582da-83f3-1644-e063-6294a90a8968SPL set ID 2bc57111-0f15-b237-e063-6294a90a4471RxCUI 360348UNII U3RSY48JW5UPC 0384415044010
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N484415004401followed by a unit qualifier and the quantityPackage 84415-0044-01. 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 occasional minor irritation and pain associated with sore mouth and throat
Excerpt only. Read the full label for complete information.
About NDC 84415-044
- What is NDC 84415-044?
- 84415-044 is the product NDC for Benzocaine (topical anesthetic), Benzocaine 200 mg/mL spray, listed with the FDA by Everpharm LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Benzocaine (Topical Anesthetic).
- What is the active ingredient?
- Benzocaine.
- Who is the labeler?
- Everpharm LLC, NDC labeler code 84415. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Benzocaine?
- 2 other product NDCs are listed under this name. See all Benzocaine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Benzocaine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Benzocaine | Benzocaine 200 mg/mL | GelTopical | Bellus Medical, LLC | 71888-101 | 71888-0101-02 |
| Benzocaine | Isopropyl alcohol 60 mg/100mL; Benzocaine 6 mg/100mL | SwabTopical | Dynarex Corporation | 67777-246 | 67777-0246-0267777-0246-04 |
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 |
|---|---|---|---|---|
| 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavityfluoride | Fluoride ion .1 mg/mL | MouthwashOral | WHOLE FOODS | 42681-0048 |
| 3ECARE Dual formula WhiteningToothpaste Refillsodium fluoride | Sodium fluoride .155 g/100g | OintmentSubgingival | Hangzhou Namei Zhikang Technology Co., Ltd. | 87514-002 |
| 3x Medicated Mouth Sore Gelbenzocaine | Zinc chloride .15 g/100g + 2 more ingredients | GelOral | Walgreens | 0363-1605 |
| 3X Medicated Mouth Sore Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-6170 |
| 3x Medicated Mouth Sore Gelbenzocaine | Menthol, Unspecified form .1 g/100g + 2 more ingredients | GelOral | HEB | 37808-691 |
| 3x Medicated Mouth Sore Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | CVS | 69842-660 |
| 3x Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | CVS | 69842-693 |
| 4-in-1 Teeth Care Pens | Sodium fluoride .25 g/100g | Gel, DentifriceTopical | Jiangxi Dentalbright Technology Co., Ltd | 83778-011 |
| 4X Medicated Severe Toothache and Gum Creambenzocaine | Benzocaine 20 g/100g + 3 more ingredients | CreamOral | Rite Aid | 11822-0614 |
| 4X Medicated Severe Toothache and Gum Gelbenzocaine | Benzalkonium chloride .13 g/100g + 3 more ingredients | GelOral | Rite Aid | 11822-0615 |
| 4x Medicated Toothache and Gum Creambenzocaine | Benzocaine 20 g/100g + 3 more ingredients | CreamOral | HEB | 37808-116 |
| 4x Medicated Toothache and Gum Creambenzocaine | Benzalkonium chloride .13 g/100g + 3 more ingredients | CreamOral | CVS | 69842-631 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Menthol, Unspecified form .5 g/100g + 3 more ingredients | GelOral | Walgreens | 0363-6008 |
| 4X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 3 more ingredients | GelOral | Walmart | 49035-569 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 3 more ingredients | Gel, DentifriceOral | Publix Super Markets INC | 56062-312 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Benzalkonium chloride .13 g/100g + 3 more ingredients | GelOral | CVS | 69842-642 |
| 7 Select Oral Pain Maximum Strength Reliefbenzocaine | Benzocaine 200 mg/g | GelTopical | 7-ELEVEN, INC. | 10202-853 |
| ABC Sore Throat Menthol Flavorphenol | Phenol 1.4 g/100mL | SprayOral | AMERISOURCE BERGEN | 46122-749 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | NuCare Pharmaceuticals,Inc. | 68071-4860 |
| Advance Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | The Atlanta Dental Supply Company DBA Advanced Dental Products | 71347-100 |
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