Over-the-counter drug · OTC MONOGRAPH DRUG
San-EZ Hand Sanitizer (Ethyl alcohol 70%) NDC 55346-3302
Alcohol 70 mL/100mL · Gel · Topical · Dental Technologies, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55346-3302-1 | 5534633020155346330201 | 236 mL in 1 BOTTLE, PLASTIC (55346-3302-1)Marketed from Apr 8, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- San-EZ Hand Sanitizer
- Generic name (nonproprietary)
- ethyl alcohol 70%
- Active ingredients
- Alcohol — 70 mL/100mL
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Dental Technologies, Inc.NDC labeler code 55346
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 55346-3302_42c8670e-5fbc-736d-e063-6394a90a2b51SPL ID 42c8670e-5fbc-736d-e063-6394a90a2b51SPL set ID a2cca707-103d-7265-e053-2995a90aebfcRxCUI 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
N455346330201followed by a unit qualifier and the quantityPackage 55346-3302-01. 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 Hand sanitizer to help reduce microbes that potentially can cause disease. For use when soap and water are not available.
Excerpt only. Read the full label for complete information.
About NDC 55346-3302
- What is NDC 55346-3302?
- 55346-3302 is the product NDC for San-EZ Hand Sanitizer (ethyl alcohol 70%), Alcohol 70 mL/100mL gel, listed with the FDA by Dental Technologies, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- San-EZ Hand Sanitizer (Ethyl Alcohol 70%).
- What is the active ingredient?
- Alcohol.
- Who is the labeler?
- Dental Technologies, Inc., NDC labeler code 55346. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for San-EZ Hand Sanitizer?
- 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 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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