Over-the-counter drug · OTC MONOGRAPH DRUG
Giltuss Bucalsep (Benzocaine, menthol, zinc chloride) NDC 58552-135
Benzocaine 6.5 g/100mL + 2 more ingredients · Spray · Oral, Topical · Gil Pharmaceutical Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58552-135-01 | 5855201350158552013501 | 1 BOTTLE, SPRAY in 1 CARTON (58552-135-01) / 30 mL in 1 BOTTLE, SPRAYMarketed from Jul 26, 2018 |
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)
- Giltuss Bucalsep
- Generic name (nonproprietary)
- benzocaine, menthol, zinc chloride
- Active ingredients
- Benzocaine — 6.5 g/100mLMenthol — .1 g/100mLZinc chloride — .12 g/100mL
- Dosage form
- Spray
- Route
- Oral, Topical
- Labeler
- Gil Pharmaceutical CorpNDC labeler code 58552
- 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 58552-135_40b86bd0-283d-5043-e063-6394a90ada9cSPL ID 40b86bd0-283d-5043-e063-6394a90ada9cSPL set ID 85053391-8d71-ab4f-e053-2991aa0a7e08RxCUI 2170427UNII U3RSY48JW5, L7T10EIP3A, 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, Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N458552013501followed by a unit qualifier and the quantityPackage 58552-0135-01. 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 irritations, pain, sore mouth, sore throat, pain associated with canker sores, pain due to minor irritation or injury of the mouth and gums, pain due to dental procedures, pain due to minor irritations caused by dentures or orthodontic appliances, sore gums
Excerpt only. Read the full label for complete information.
About NDC 58552-135
- What is NDC 58552-135?
- 58552-135 is the product NDC for Giltuss Bucalsep, Benzocaine 6.5 g/100mL + 2 more ingredients spray, listed with the FDA by Gil Pharmaceutical Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Giltuss Bucalsep (Benzocaine, Menthol, Zinc chloride).
- What is the active ingredient?
- Benzocaine, Menthol, Zinc chloride.
- Who is the labeler?
- Gil Pharmaceutical Corp, NDC labeler code 58552. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Giltuss Bucalsep?
- 1 other product NDC are listed under this name. See all Giltuss Bucalsep NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Giltuss Bucalsep products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Giltuss Bucalsepbenzocaine, menthol, zinc chloride | Zinc cation .12 mg/100mL + 2 more ingredients | SprayOral, Topical | Dextrum Laboratories Inc. | 65852-015 | 65852-0015-01 |
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 |
|---|---|---|---|---|
| Hydrogen Peroxide 3 Percent ReadyInCasehydrogen peroxide | Hydrogen peroxide 3 mL/100mL | LiquidTopical | P & L Development, LLC | 49580-0268 |
| Salinenasal | Sodium chloride 6.5 mg/mL | SprayNasal | Bi-Mart | 37835-998 |
| CVS Health Sensitive Enamel Repairsodium fluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceOral | CVS | 51316-169 |
| Ricola Max Nasal Care Cool Mentholmenthol | Menthol 15.3 mg/1 | LozengeOral | Ricola Ag | 54305-206 |
| Orajel Medicated for Toothache and Gum, Liquidbenzocaine and menthol | Benzocaine 200 mg/mL; Menthol, Unspecified form 1 mg/mL | LiquidTopical | Church & Dwight Co., Inc. | 10237-796 |
| Throat Balm Caramel Pectinpectin | Pectin 3.8 mg/1 | LozengeOral | Ricola Ag | 54305-301 |
| Throat Balm Caramel Pectinpectin | Pectin 3.8 mg/1 | LozengeOral | Ricola USA Inc. | 63667-301 |
| Hydrogen Peroxide 3 Percenthydrogen peroxide | Hydrogen peroxide 2.65 mL/100mL | LiquidTopical | Whole Foods Market | 42681-6414 |
| Sore throat cherryphenol | Phenol 1.4 g/100mL | SprayOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-376 |
| Crest Pro-Health Gum DetoxifyWinter Mintcetylpyridinium chloride | Cetylpyridinium chloride .07 g/mL | RinseOral | The Procter & Gamble Manufacturing Company | 84126-648 |
| Crest Kids Advanced Color Changingsodium monofluorophosphate | Sodium monofluorophosphate 1.6 mg/g | Paste, DentifriceDental | Procter & Gamble Manufactura, S de R.L. de C.V. | 58933-012 |
| Sootheez Berry Lemonadepectin | Pectin 11.5 mg/3.5g | LozengeOral | BFY LLC | 72427-4014 |
| Sootheez Organic Wild Cherrypectin | Pectin 11.5 mg/3.5g | LozengeOral | BFY LLC | 72427-3714 |
| Quality Choice Oral Pain Reliefbenzocaine 20%, benzalkonium chloride 1% | Benzocaine 200 mg/g; Benzalkonium chloride 10 mg/g | GelTopical | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | 83324-035 |
| Rite Aid Professional Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Rite Aid | 11822-5340 |
| SENSODYNE Rapid Reliefstannous fluoride | Stannous fluoride 1.1 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0622 |
| Iodent Oral Analgesicbenzocaine | Benzocaine 200 mg/g | GelTopical | United Exchange Corp. | 65923-094 |
| Sootheez Organic Wild Cherrypectin | Pectin 11.5 mg/3.5g | LozengeOral | BFY LLC | 72427-3714 |
| Topcare Sore Throat Menthol Flavorphenol | Phenol 1.4 g/100mL | SprayOral | TOPCO ASSOCIATES LLC | 36800-606 |
| 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 |
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