Over-the-counter drug · OTC MONOGRAPH DRUG
Iolite (Benzocaine) NDC 53045-133
Benzocaine 6.4 g/100g · Gel · Dental, Oral · Dharma Research, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53045-133-30 | 5304501333053045013330 | 32 g in 1 BOTTLE (53045-133-30)Marketed from Jul 19, 2017 |
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)
- Iolite
- Generic name (nonproprietary)
- benzocaine
- Active ingredients
- Benzocaine — 6.4 g/100g
- Dosage form
- Gel
- Route
- Dental, Oral
- Labeler
- Dharma Research, Inc.NDC labeler code 53045
- 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 53045-133_63fecd9c-19fc-40bc-89e0-32c0cd5ddcf7SPL ID 63fecd9c-19fc-40bc-89e0-32c0cd5ddcf7SPL set ID 142a8824-657e-492a-8e5a-b15eb73383c9UNII 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 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
N453045013330followed by a unit qualifier and the quantityPackage 53045-0133-30. 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 associated with canker sores and minor dental procedures.
Excerpt only. Read the full label for complete information.
About NDC 53045-133
- What is NDC 53045-133?
- 53045-133 is the product NDC for Iolite (benzocaine), Benzocaine 6.4 g/100g gel, listed with the FDA by Dharma Research, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Iolite (Benzocaine).
- What is the active ingredient?
- Benzocaine.
- Who is the labeler?
- Dharma Research, Inc., NDC labeler code 53045. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Iolite?
- 7 other product NDCs are listed under this name. See all Iolite NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Iolite products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Iolitebenzocaine | Benzocaine 6.4 g/100g | GelDental, Oral | Dharma Research, Inc. | 53045-135 | 53045-0135-30 |
| Iolitebenzocaine | Benzocaine 6.4 g/100g | GelDental, Oral | Dharma Research, Inc. | 53045-136 | 53045-0136-30 |
| Iolitebenzocaine | Benzocaine 6.4 g/100g | GelDental, Oral | Dharma Research, Inc. | 53045-138 | 53045-0138-30 |
| Iolitebenzocaine | Benzocaine 6.4 g/100g | GelDental, Oral | Dharma Research, Inc. | 53045-134 | 53045-0134-30 |
| Iolitebenzocaine | Benzocaine 6.4 g/100g | GelDental, Oral | Dharma Research, Inc. | 53045-131 | 53045-0131-30 |
| Iolitebenzocaine | Benzocaine 6.4 g/100g | GelDental, Oral | Dharma Research, Inc. | 53045-132 | 53045-0132-30 |
| Iolitebenzocaine | Benzocaine 6.4 g/100g | GelDental, Oral | Dharma Research, Inc. | 53045-130 | 53045-0130-30 |
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 |
|---|---|---|---|---|
| Oral Gel Oral Pain Reliefbenzocaine benzalkonium chloride | Benzocaine 20 g/100g; Benzalkonium chloride .1 g/100g | GelTopical | Savvy Care and Cosmetics | 83650-101 |
| Boka Sensitivepotassium nitrate | Potassium nitrate 5 g/100g | Paste, DentifriceDental | Karaka LLC | 87161-444 |
| Sensodyne Pronamel Gentle Whitening Advancedpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0580 |
| Lolleez Variety Packpectin | Pectin 11.5 mg/7g | LozengeOral | BFY LLC | 72427-3195 |
| UltraCare Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Periodontal, Topical | The Bellport Company, Inc. dba Gingi-Pak | 10129-071 |
| Chloraseptic Childrens Sore Throat Cherryphenol | Phenol 1.4 g/100mL | SprayOral | Prestige Brands Holdings, Inc. | 67172-930 |
| Quality Choicebenzocaine | Benzocaine 200 mg/g | GelTopical | Chain Drug Marketing Association, Inc. | 83324-299 |
| Chloraseptic Sore Throat Maxphenol and glycerin | Phenol 15 mg/mL; Glycerin 330 mg/mL | SprayOral | Prestige Brands Holdings, Inc. | 67172-937 |
| Orajel 3X Medicated For Toothache and Gumbenzocaine, menthol, zinc chloride | Menthol 2.6 mg/g + 2 more ingredients | GelTopical | Church & Dwight Co., Inc. | 10237-790 |
| SENSODYNE Rapid Reliefstannous fluoride | Stannous fluoride 1.1 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0622 |
| Antisepticeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | LiquidOral | WALMART INC. (see also Equate) | 79903-151 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0008 |
| Mucinex Instasoothe Sore Throat Plus Pain Reliefbenzocaine and menthol, unspecified form | Benzocaine 7 g/100mL; Menthol, Unspecified form 1 g/100mL | SprayOral | Reckitt Benckiser LLC | 72854-265 |
| HEB Extra Whiteningfluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceDental | HEB | 37808-961 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0005 |
| Mucinex Instasoothe Sore Throat Plus Pain Reliefhexylresorcinol | Hexylresorcinol 2 mg/1 | LozengeOral | Reckitt Benckiser LLC | 72854-262 |
| Crest Scope Originalcetylpyridinium chloride | Cetylpyridinium chloride .014 g/mL | RinseOral | The Procter & Gamble Manufacturing Company | 84126-602 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0006 |
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0920 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0007 |
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