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 | 5386300020153863000201 | 50 mL in 1 BOTTLE (53863-002-01)Marketed from Aug 3, 2020 | |
| 53863-002-02 | 5386300020253863000202 | 200 mL in 1 BOTTLE (53863-002-02)Marketed from Aug 3, 2020 | |
| 53863-002-03 | 5386300020353863000203 | 250 mL in 1 BOTTLE (53863-002-03)Marketed from Aug 3, 2020 | |
| 53863-002-04 | 5386300020453863000204 | 475 mL in 1 BOTTLE (53863-002-04)Marketed from Aug 3, 2020 | |
| 53863-002-05 | 5386300020553863000205 | 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.NDC labeler code 53863
- 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.
About NDC 53863-002
- What is NDC 53863-002?
- 53863-002 is the product NDC for Hand Sanitizer (ethyl alcohol), Alcohol 70 mL/100mL gel, listed with the FDA by Exelencia Importers, Corp.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hand Sanitizer (Ethyl Alcohol).
- What is the active ingredient?
- Alcohol.
- Who is the labeler?
- Exelencia Importers, Corp., NDC labeler code 53863. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hand Sanitizer?
- 145 other product NDCs are listed under this name. See all Hand Sanitizer NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hand Sanitizer products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hand Sanitizerethyl alcohol | Alcohol 62 g/100mg | LiquidTopical | Guangzhou Yilong Cosmetics.,Ltd | 74458-968 | 74458-0968-0174458-0968-0274458-0968-03 |
| Hand Sanitizerethyl alcohol | Alcohol 7 mL/10mL | SprayTopical | NANTONG HAIYIWEI TEXTILE CO., LTD. | 87858-001 | 87858-0001-01 |
| Hand Sanitizerethyl alcohol | Alcohol 6.2 mL/10mL | SprayTopical | NANTONG HAIYIWEI TEXTILE CO., LTD. | 87858-002 | 87858-0002-01 |
| Hand Sanitizerethyl alcohol | Alcohol 62 g/112mL | GelTopical | NANTONG HAIYIWEI TEXTILE CO., LTD. | 87858-004 | 87858-0004-0187858-0004-0287858-0004-03+1 more |
| Hand Sanitizerethyl alcohol | Alcohol 62 g/112mL | GelTopical | NANTONG HAIYIWEI TEXTILE CO., LTD. | 87858-005 | 87858-0005-01 |
| Hand sanitizerhand sanitizer spray | Alcohol 70 g/100mL | SprayTopical | Beimei Biotechnology (Guangzhou) Co., Ltd. | 87374-003 | 87374-0003-01 |
| Hand sanitizerhand sanitizer spray | Alcohol 70 g/100mL | SprayTopical | Beimei Biotechnology (Guangzhou) Co., Ltd. | 87374-002 | 87374-0002-01 |
| Hand Sanitizeralcohol | Alcohol 62 mL/100mL | LiquidCutaneous | Guangdong Yanze Biotechnology Co., Ltd. | 87660-106 | 87660-0106-01 |
| Hand Sanitizeralcohol | Alcohol 70 mL/100mL | SprayTopical | MerchSource, LLC | 87498-102 | 87498-0102-02 |
| Hand Sanitizerethyl alcohol | Alcohol 7 mL/10mL | LiquidTopical | Zhejiang Gaorong Cosmetic Co., Ltd. | 85472-010 | 85472-0010-0185472-0010-02 |
Other NDCs under 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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