Over-the-counter drug · OTC MONOGRAPH DRUG
Gumsol NDC 52083-714
benzocaine, zinc chloride · Benzocaine 1.5 g/30mL; Zinc chloride .03 g/30mL · Spray · Oral · Kramer Novis
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52083-714-01 | 52083071401 | 30 mL in 1 BOTTLE (52083-714-01)Marketed from Feb 28, 2014 |
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)
- Gumsol
- Generic name (nonproprietary)
- benzocaine, zinc chloride
- Active ingredients
- Benzocaine — 1.5 g/30mLZinc chloride — .03 g/30mL
- Dosage form
- Spray
- Route
- Oral
- Labeler
- Kramer Novis
- 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)Decreased Copper Ion Absorption (Physiologic effect)Increased Histamine Release (Physiologic effect)
- Identifiers
- Product ID 52083-714_df716e50-f0a6-4548-b354-29dd8c29924cSPL ID df716e50-f0a6-4548-b354-29dd8c29924cSPL set ID 3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bfRxCUI 485558UNII U3RSY48JW5, 86Q357L16B
- Pharmacologic class
- Copper Absorption Inhibitor; 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
N452083071401followed by a unit qualifier and the quantityPackage 52083-0714-01. 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)
Use Temporarily relieves pain due to toothaches, canker sores or minor mouth injuries of the mouth and gums caused by dentures or orthodontic appliances.
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| Finafta MultiOralbenzocaine | Benzocaine 7.5 mg/100mL | SprayOral | Efficient Laboratories Inc. | 58593-782 |
| DenTek Instant Pain Relief Maximum Strengthbenzocaine | Benzocaine 200 mg/mL | LiquidDental, Topical | DenTek Oral Care, Inc. | 60630-078 |
| Astra-dent Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | Zag Usa Inc | 71363-102 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0008 |
| Natural Cherry Honey Herb Throat Dropsmenthol | Menthol 2.1 mg/1 | LozengeOral | Ricola USA Inc. | 63667-517 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0009 |
| HurriCaine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0622 |
| Astra-dent Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | Zag Usa Inc | 71363-100 |
| Toothachepolyhexamethylene biguanide hydrochloride | Polihexanide hydrochloride .25 g/100mL | SprayTopical | Guchutang Biotechnology (Longyan) Co., Ltd | 87083-012 |
| Sore Mouth Cleanserhydrogen peroxide | Hydrogen peroxide 15 mg/mL | MouthwashTopical | Meijer, Inc. | 41250-750 |
| Pearson Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Pearson Dental Supplies INC. | 43305-0010 |
| Cherry Throat Dropsmenthol | Menthol 1.3 mg/1 | LozengeOral | Ricola USA Inc. | 63667-518 |
| Astra-dent Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | Zag Usa Inc | 71363-101 |
| EcoDent Ultimate Essential Mouthcare Sparkling Clean Mintsodium bicarbonate | Sodium bicarbonate 25 mg/mL | LiquidOral | Lotus Brands, Inc. | 76328-223 |
| Parodontax Active Gum Health Daily Mouthwash Breath Freshenercetylpyridinium chloride | Cetylpyridinium chloride 70 mg/mL | LiquidOral | Haleon US Holdings LLC | 0135-0652 |
| Patterson Dental Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Patterson Dental | 50227-1014 |
| Natural Lemon Mint Herb Throat Dropsmenthol | Menthol 1.5 mg/1 | LozengeOral | Ricola Ag | 54305-489 |
| Quality Choice Maximum Strength Oral Pain Relievingbenzocaine | Benzocaine 20 g/100g | GelTopical | Chain Drug Marketing Association Inc | 63868-953 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-116 |
| Patterson Dental Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Patterson Dental | 50227-1011 |
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