Over-the-counter drug · OTC MONOGRAPH DRUG
Hand Sanitizer (ethyl alcohol) NDC 53863-002
Alcohol 70 mL/100mL · Gel · Topical · Exelencia Importers, Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53863-002-01 | 53863000201 | 50 mL in 1 BOTTLE (53863-002-01)Marketed from Aug 3, 2020 | |
| 53863-002-02 | 53863000202 | 200 mL in 1 BOTTLE (53863-002-02)Marketed from Aug 3, 2020 | |
| 53863-002-03 | 53863000203 | 250 mL in 1 BOTTLE (53863-002-03)Marketed from Aug 3, 2020 | |
| 53863-002-04 | 53863000204 | 475 mL in 1 BOTTLE (53863-002-04)Marketed from Aug 3, 2020 | |
| 53863-002-05 | 53863000205 | 4000 mL in 1 BOTTLE (53863-002-05)Marketed from Aug 3, 2020 |
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)
- Hand Sanitizer
- Generic name (nonproprietary)
- ethyl alcohol
- Active ingredients
- Alcohol — 70 mL/100mL
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Exelencia Importers, Corp.
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 53863-002_1c250982-7ac2-a037-e063-6294a90ad6f6SPL ID 1c250982-7ac2-a037-e063-6294a90ad6f6SPL set ID abffec96-20e5-fd78-e053-2a95a90a4b08RxCUI 581662UNII 3K9958V90M
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N453863000201followed by a unit qualifier and the quantityPackage 53863-0002-01. 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 Decreases bacteria on skin that pontetially can cause disease Recommended for repeated use.
Excerpt only. Read the full label for complete information.
Other NDCs under 505G(a)(3)
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 |
|---|---|---|---|---|
| XPRO Antiseptic Hand Sanitizeralcohol | Alcohol .7 mL/mL | GelTopical | Savone SA | 77939-000 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8397 |
| Fresh Feels Hand Sanitizer Mist Papaya Sunset Scentethyl alcohol | Alcohol 70 mL/100mL | SprayTopical | Amber Glow Cosmetics Limited | 87302-205 |
| Touchland Power Mist Hand Sanitizer Unscentedalcohol | Alcohol .7 mL/mL | SprayTopical | Church & Dwight Co., Inc. | 10237-109 |
| PURELL Hand Sanitizing Wipes Clean Refreshing Scentbenzalkonium chloride wipe | Benzalkonium chloride .13 mg/100mL | ClothTopical | GOJO Industries, Inc. | 21749-359 |
| berries and cream hand sanitizeralcohol | Alcohol .62 mL/mL | GelTopical | Target Corporation | 11673-785 |
| Safeguard Hand Sanitizeralcohol | Alcohol 64 g/100mL | GelTopical | The Procter & Gamble Manufacturing Company | 37000-603 |
| Hand Washbenzalkonium chloride | Benzalkonium chloride 1.3 mg/mL | LiquidTopical | Demoulas Super Markets, Inc | 53942-466 |
| Dial Professional Antibacterial Defense Spring Waterbenzalkonium chloride | Benzalkonium chloride .13 g/100mL | SolutionTopical | Henkel Corporation | 54340-121 |
| CVS Antisepticcetylpyridinium chloride | Cetylpyridinium chloride .7 mg/mL | RinseOral | CVS Pharmacy, Inc. | 59779-299 |
| Anti Bacterial Hand Gel Winteralcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6957 |
| Anti Bacterial Hand Gel Black Cherry Merlotalcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6693 |
| Antibacterial Foaming Skin Cleanserbenzalkonium chloride | Benzalkonium chloride .13 mg/mL | SoapTopical | Betco Corporation, Ltd. | 65601-709 |
| Hawthorn Hygiene Solutions ENERGY ANTIBACTERIAL FOAM FRAGRANCE FREE 1200 mLbenzalkonium chloride | Benzalkonium chloride .0013 mg/mL | LiquidTopical | BUNZL Distribution | 66294-114 |
| PRO-LINK Free Hands Antibacterial Foam So apchloroxylenol | Chloroxylenol .003 mg/mL | LiquidTopical | Pro-Link, Inc. | 66908-081 |
| B-Pure Moisturizing Hand Sanitizer with Collagen Sugared Iris Scentedalcohol | Alcohol 70 mL/100mL | LiquidTopical | Fourstar Group USA, Inc. | 80684-227 |
| Fresh Feels Hand Sanitizer Mist Seashell Sunshine Scentethyl alcohol | Alcohol 70 mL/100mL | SprayTopical | Amber Glow Cosmetics Limited | 87302-202 |
| Sparkling Cranberry Hand Sanitizeralcohol | Alcohol .62 mL/mL | GelTopical | Target Corporation | 11673-782 |
| Safeguard Antibacterial Foamingbenzalkonium chloride | Benzalkonium chloride .12 g/100mL | SoapTopical | The Procter & Gamble Manufacturing Company | 37000-601 |
| Advanced Hand Sanitizeralcohol | Alcohol 70 mL/100mL | GelTopical | Salado Sales Inc. | 57243-370 |
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