Over-the-counter drug · OTC MONOGRAPH DRUG
SunDrops 77 (Benzalkonium chloride) NDC 63621-354
Benzalkonium chloride 1 mg/mL · Soap · Topical · Sunburst Chemicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63621-354-40 | 6362103544063621035440 | 4 BAG in 1 BOX (63621-354-40) / 1000 mL in 1 BAGMarketed from Oct 16, 2025 | |
| 63621-354-85 | 6362103548563621035485 | 8 BAG in 1 BOX (63621-354-85) / 1000 mL in 1 BAGMarketed from Sep 28, 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)
- SunDrops 77
- Generic name (nonproprietary)
- benzalkonium chloride
- Active ingredients
- Benzalkonium chloride — 1 mg/mL
- Dosage form
- Soap
- Route
- Topical
- Labeler
- Sunburst Chemicals, Inc.NDC labeler code 63621
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 63621-354_43535ccc-3e06-c1e0-e063-6294a90a3acbSPL ID 43535ccc-3e06-c1e0-e063-6294a90a3acbSPL set ID fc0ba65c-5307-4251-a60b-cde84ad56ad8UNII F5UM2KM3W7
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
N463621035440followed by a unit qualifier and the quantityPackage 63621-0354-40. 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 hand sanitizing to decrease bacteria on the skin Recommended for repeated use
Excerpt only. Read the full label for complete information.
About NDC 63621-354
- What is NDC 63621-354?
- 63621-354 is the product NDC for SunDrops 77 (benzalkonium chloride), Benzalkonium chloride 1 mg/mL soap, listed with the FDA by Sunburst Chemicals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- SunDrops 77 (Benzalkonium Chloride).
- What is the active ingredient?
- Benzalkonium chloride.
- Who is the labeler?
- Sunburst Chemicals, Inc., NDC labeler code 63621. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for SunDrops 77?
- 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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