Over-the-counter drug · OTC MONOGRAPH DRUG
Biopure (Hand sanitizer spray) NDC 78691-028
Alcohol 16 g/30mL · Liquid · Topical · Quest USA Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78691-028-01 | 7869100280178691002801 | 30 mL in 1 BOTTLE, SPRAY (78691-028-01)Marketed from Apr 15, 2025 |
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)
- Biopure
- Generic name (nonproprietary)
- hand sanitizer spray
- Active ingredients
- Alcohol — 16 g/30mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Quest USA CorpNDC labeler code 78691
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 003
- Marketing start
- Listing expires
- Identifiers
- Product ID 78691-028_3a3c0aa0-7504-7ef0-e063-6294a90a9f94SPL ID 3a3c0aa0-7504-7ef0-e063-6294a90a9f94SPL set ID 3249f563-7968-e512-e063-6394a90aad52UNII 3K9958V90MUPC 0198926005640
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
N478691002801followed by a unit qualifier and the quantityPackage 78691-0028-01. 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)
Use Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use.
Excerpt only. Read the full label for complete information.
About NDC 78691-028
- What is NDC 78691-028?
- 78691-028 is the product NDC for Biopure (hand sanitizer spray), Alcohol 16 g/30mL liquid, listed with the FDA by Quest USA Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Biopure (Hand Sanitizer Spray).
- What is the active ingredient?
- Alcohol.
- Who is the labeler?
- Quest USA Corp, NDC labeler code 78691. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Biopure?
- 2 other product NDCs are listed under this name. See all Biopure NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Biopure products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Biopurehand sanitizer spray | Alcohol 16 g/30mL | LiquidTopical | Quest USA Corp | 78691-027 | 78691-0027-01 |
| Biopurehand sanitizer spray | Alcohol 16 g/30mL | LiquidTopical | Quest USA Corp | 78691-029 | 78691-0029-01 |
Other NDCs under M 003
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 |
|---|---|---|---|---|
| Antisepticethanol | Alcohol .62 mL/mL | GelTopical | McKesson | 68599-5322 |
| Hand sanitizer 16.9oz with vitamin Eethyl alcohol 70% | Alcohol 70 mL/100mL | LiquidTopical | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 75742-021 |
| Mistify Pina Colada Hand Sanitezeralcohol antiseptic | Alcohol 62 mL/100mL | LiquidTopical | Kingkey MBC Life Technology Group Co.,Ltd | 73928-178 |
| Solar Flare Hand Sanitizer Sunset Sambaalcohol | Alcohol 62 mL/100mL | SprayTopical | Scent Theory Products LLC | 76891-153 |
| Klean Freakbenzalkonium chloride | Benzalkonium chloride .13 g/100g | ClothTopical | KLEAN FREAK, LLC | 78982-005 |
| Guardellebenzalkonium chloride | Benzalkonium chloride .13 g/100mL | Aerosol, FoamTopical | Social Medical Supply LLC | 85754-000 |
| RITE AID Maximum strength pain relievingbenzalkonium chloride and lidocaine hydrochloride | Benzalkonium chloride .13 g/100mL; Lidocaine hydrochloride 4 g/100mL | LiquidTopical | RITE AID | 11822-7220 |
| Hand Sanitizer | Alcohol 70 mL/100mL | GelExtracorporeal | Zhejiang Meimi Technology Co., Ltd. | 41366-055 |
| Smart Care Cucumber Melon Hand Sanitizeralcohol | Alcohol 70 mL/100mL | SprayTopical | Shenzhen Lantern Scicence Co.,Ltd. | 54860-509 |
| Walgreen Maximum strength pain relieving cleansingbenzalkonium chloride and lidocaine hydrochloride | Benzalkonium chloride .13 g/100mL; Lidocaine hydrochloride 4 g/100mL | LiquidTopical | WALGREENS CO. | 0363-7020 |
| American Red Cross 70% Ethyl Alcohol Hand Sanitizerethyl alcohol | Alcohol 70 mL/100mL | GelTopical | Zhejiang Guoyao Jingyue Aerosol Co., Ltd | 75742-018 |
| Thompson Burn Cream with Lidocainebenzalkonium chloride, lidocaine | Lidocaine hydrochloride 5 mg/g; Benzalkonium chloride 1.3 mg/g | CreamTopical | Thompson Safety | 73408-160 |
| Scentfull Hand Sanitizer Whipped Coconutalcohol | Alcohol 62 mL/100mL | SprayTopical | Scent Theory Products LLC | 76891-150 |
| Klean Freakbenzalkonium chloride | Benzalkonium chloride .13 g/100g | ClothTopical | KLEAN FREAK, LLC | 78982-002 |
| Hand Sanitizeralcohol 62% | Alcohol .62 g/g | GelTopical | Guangzhou Ailizhuangsi Cosmetics Co., Ltd. | 87910-009 |
| Obstetrical Towelettebenzalkonium chloride | Benzalkonium chloride 1.3 mg/g | ClothTopical | Jianerkang Medical Co., Ltd | 34645-0015 |
| Hand Sanitizer | Alcohol 70 mL/100mL | GelExtracorporeal | Zhejiang Meimi Technology Co., Ltd. | 41366-052 |
| Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Hibiscus Nectarethyl alcohol | Alcohol 70 mL/100mL | SprayTopical | MY IMPORTS USA LLC | 51628-4563 |
| Soft Touch Plus Antibacterial Hand Item 1039chloroxylenol | Chloroxylenol .3 g/100mL | SoapTopical | AMERICAN CHEMICAL AND SANITARY SUPPLY INC | 50536-139 |
| Hydrogen Peroxide | Hydrogen peroxide 30 mg/mL | SolutionTopical | Perrigo Direct, Inc | 50804-871 |
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