Over-the-counter drug · OTC MONOGRAPH DRUG
Gly-Oxide (Carbamide peroxide) NDC 63029-500
Carbamide peroxide 100 mg/mL · Liquid · Oral · Medtech Products Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63029-500-01 | 63029050001 | 1 BOTTLE in 1 CARTON (63029-500-01) / 15 mL in 1 BOTTLEMarketed from Jun 1, 2012 | |
| 63029-500-02 | 63029050002 | 1 BOTTLE in 1 CARTON (63029-500-02) / 60 mL in 1 BOTTLEMarketed from Jun 1, 2012 |
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)
- Gly-Oxide
- Generic name (nonproprietary)
- carbamide peroxide
- Active ingredients
- Carbamide peroxide — 100 mg/mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Medtech Products Inc.NDC labeler code 63029
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Identifiers
- Product ID 63029-500_4c198ce8-ecfe-4ea1-99b7-fcc65f6346b8SPL ID 4c198ce8-ecfe-4ea1-99b7-fcc65f6346b8SPL set ID 086a0b82-e947-41c9-89e7-ba06483960c9RxCUI 582808, 1048144UNII 31PZ2VAU81
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
N463029050001followed by a unit qualifier and the quantityPackage 63029-0500-01. 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 temporary use in cleansing: canker sores minor wounds or gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
Excerpt only. Read the full label for complete information.
About NDC 63029-500
- What is NDC 63029-500?
- 63029-500 is the product NDC for Gly-Oxide (carbamide peroxide), Carbamide peroxide 100 mg/mL liquid, listed with the FDA by Medtech Products Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gly-Oxide (Carbamide Peroxide).
- What is the active ingredient?
- Carbamide peroxide.
- Who is the labeler?
- Medtech Products Inc., NDC labeler code 63029. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gly-Oxide?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Vicks VapoCool SEVERE plus Intense Pain Reliefbenzocaine and menthol | Benzocaine 15 mg/1; Menthol 20 mg/1 | LozengeOral | The Procter & Gamble Manufacturing Company | 84126-366 |
| Meijer Sore Throatphenol | Phenol 1.4 g/100mL | SprayOral | MEIJER DISTRIBUTION INC. | 41250-632 |
| Advance Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | The Atlanta Dental Supply Company DBA Advanced Dental Products | 71347-105 |
| Anadent Kanka Gelbenzocaine | Benzocaine 200 mg/g | GelDental | BELMORA LLC | 27854-177 |
| Rexall Maximum Strengthbenzocaine | Benzocaine 20 g/100mL | LiquidOral | Rexall | 55910-346 |
| HurriCaine Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental, Oral, Periodontal | Beutlich Pharmaceuticals, LLC | 0283-0886 |
| Orajel 3X Medicated For All Mouth Soresbenzocaine, menthol, zinc chloride | Benzocaine 200 mg/g + 2 more ingredients | GelTopical | Church & Dwight Co., Inc. | 10237-783 |
| 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 |
| Gelato Topical Anestheticbenzocaine | Benzocaine 11.4 g/57g | Spray, MeteredDental | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 68400-323 |
| Vicks Vapo Breathersmenthol | Menthol 20 mg/1 | LozengeOral | The Procter & Gamble Manufacturing Company | 84126-320 |
| SENSODYNE PRONAMEL Active Shield Fresh Mintpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0700 |
| Sore Throatphenol | Phenol 1.4 g/100mL | SprayOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-376 |
| Ludens Honey Licorice Throat Dropsmenthol | Menthol 1.6 mg/1 | LozengeOral | Prestige Brands Holdings, Inc. | 52183-255 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-113 |
| Candee Caine Topical Anestheticbenzocaine | Benzocaine 200 mg/g | GelDental | Top Quality Manufacturing, Inc. | 69301-061 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-115 |
| Ludens Wild Cherry Throat Dropspectin | Pectin 2.8 mg/1 | LozengeOral | Prestige Brands Holdings, Inc. | 52183-229 |
| Kaylaanzero waste refill for toothpaste | Sodium fluoride .37 mg/440mg | Tablet, ChewableDental | Kaylaan LLC | 82091-116 |
| SENSODYNE Sensitivity Gum and Enamel Mintstannous fluoride | Stannous fluoride 1.1 mg/g | PasteOral | Haleon US Holdings LLC | 0135-5022 |
| Ludens Sugar Free Wild Cherry Throatpectin | Pectin 2.8 mg/1 | LozengeOral | Prestige Brands Holdings, Inc. | 52183-249 |
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