Over-the-counter drug · OTC MONOGRAPH DRUG
Spectrum 62% Hand Sanitizer (Ethyl alcohol) NDC 53329-214
Alcohol 62 mL/100mL · Gel · Topical · Medline Industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53329-214-84 | 53329021484 | 1000 mL in 1 BAG (53329-214-84)Marketed from Apr 9, 2018 | |
| 53329-214-85 | 53329021485 | 354 mL in 1 BOTTLE (53329-214-85)Marketed from Apr 9, 2018 |
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)
- Spectrum 62% Hand Sanitizer
- Generic name (nonproprietary)
- ethyl alcohol
- Active ingredients
- Alcohol — 62 mL/100mL
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Medline Industries, LPNDC labeler code 53329
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 53329-214_4a8e3675-99a2-b6e6-e063-6394a90a7d48SPL ID 4a8e3675-99a2-b6e6-e063-6394a90a7d48SPL set ID 6971b7de-039d-292f-e053-2a91aa0a26b2RxCUI 581660UNII 3K9958V90MUPC 0888277351441
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
N453329021484followed by a unit qualifier and the quantityPackage 53329-0214-84. 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 to decrease bacteria on the skin that could cause disease recommended for repeated use
Excerpt only. Read the full label for complete information.
About NDC 53329-214
- What is NDC 53329-214?
- 53329-214 is the product NDC for Spectrum 62% Hand Sanitizer (ethyl alcohol), Alcohol 62 mL/100mL gel, listed with the FDA by Medline Industries, LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Spectrum 62% Hand Sanitizer (Ethyl alcohol).
- What is the active ingredient?
- Alcohol.
- Who is the labeler?
- Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Spectrum 62% 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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| PIOELLY Arnica Bruise Cream | Arnica montana 7 g/100g | CreamTopical | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 84558-029 |
| FluMisch Minoxidil Foamminoxidil,biotin | Minoxidil 5 g/100mL; Biotin 5 g/100mL | Aerosol, FoamExtracorporeal | Beijing JUNGE Technology Co., Ltd. | 85212-0001 |
| 0.025% Capsaicin Pain relief Patchcapsaicin pain relief patch, capsaicin pain relief strip | Capsaicin .025 g/100g | PatchTopical | Xuzhou Lanting Pharmaceutical Co., Ltd | 85323-005 |
| BodyMed Alcohol Prep Padalcohol prep pad | Isopropyl alcohol 70 mL/100mL | SwabTopical | Boxout, LLC | 82308-001 |
| Senna Timesennosides | Sennosides a and b 8.6 mg/1 | Tablet, CoatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8402 |
| VQ Hydrating Hand Sanitizer Capri Summeralcohol | Alcohol 70 mL/100mL | LiquidTopical | Tychea Co. | 85980-011 |
| Laxative Sennasennosides | Sennosides 8.6 mg/1 | Tablet, CoatedOral | TOPCO ASSOCIATES LLC | 36800-984 |
| Swisherbenzalkonium chloride | Benzalkonium chloride 5 mg/mL | SolutionTopical | Ecolab Inc. | 47593-591 |
| enMotion Antimicrobial with Moisturizers, Fragrance Freebenzalkonium chloride | Benzalkonium chloride 1.3 mg/mL | SoapTopical | Georgia-Pacific Consumer Products LP | 54622-703 |
| Sterile Alcohol Prep Pads 01isopropyl alcohol | Isopropyl alcohol .7 mL/mL | SwabTopical | Total Resources International Inc. | 55550-222 |
| Anti Bacterial Hand Gel Pink Gumballalcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6654 |
| Anti Bacterial Hand Gel Fresh Rainfallalcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6930 |
| Wet Ones Antibacterial Hand Wipes Lavender Scentbenzalkonium chloride | Benzalkonium chloride .13 g/100g | SwabTopical | Edgewell Personal Care Brands LLC | 63354-536 |
| Senna-Sdocusate sodium, sennosides | Sennosides 8.6 mg/1; Docusate sodium 50 mg/1 | Tablet, Film coatedOral | Granulation Technology, Inc. | 63561-0187 |
| Sani-Surealcohol | Alcohol 600 mL/L | GelTopical | Whisk Products, Inc. | 65585-359 |
| Smart Care ANTIBACTERIAL HAND SANITIZING WIPES LAVENDER SCENTbenzalkonium chloride | Benzalkonium chloride .11 g/100mL | ClothTopical | Ashtel Studios, Inc. | 70108-208 |
| 4% Lidocaine Pain Relief Patchlidocaine pain relief patch | Lidocaine hydrochloride 4 g/100g | PatchTopical | Xuzhou Lanting Pharmaceutical Co., Ltd | 85323-002 |
| B-Pure Moisturizing Hand Sanitizer Pink Berry Pop Scentedalcohol | Alcohol 70 mL/100mL | LiquidTopical | Fourstar Group USA, Inc. | 80684-223 |
| Sipa hand sanitizer with Moisturizersinstant hand sanitizer | Alcohol 75 mL/100mL | LiquidTopical | Tourel (Changsha)Hotel Supplies Co.,Ltd | 83502-002 |
| VQ Hydrating Hand Sanitizer Pistachio Cremealcohol | Alcohol 70 mL/100mL | LiquidTopical | Tychea Co. | 85980-008 |
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