Over-the-counter drug · OTC MONOGRAPH DRUG
Maximum Strength Betadine Clear (Benzalkonium cl and pramoxine hcl) NDC 67618-183
Benzalkonium chloride .13 mg/mL; Pramoxine hydrochloride 1 mg/mL · Spray · Topical · Atlantis Consumer Healthcare, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67618-183-06 | 6761801830667618018306 | 177 mL in 1 BOTTLE (67618-183-06)Marketed from Dec 22, 2023 |
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)
- Maximum Strength Betadine Clear
- Generic name (nonproprietary)
- benzalkonium cl and pramoxine hcl
- Active ingredients
- Benzalkonium chloride — .13 mg/mLPramoxine hydrochloride — 1 mg/mL
- Dosage form
- Spray
- Route
- Topical
- Labeler
- Atlantis Consumer Healthcare, Inc.NDC labeler code 67618
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 003
- Marketing start
- Listing expires
- Identifiers
- Product ID 67618-183_074e0e6b-8391-4541-b628-bd74a5e7c29cSPL ID 074e0e6b-8391-4541-b628-bd74a5e7c29cSPL set ID 31b94a76-1536-47c0-ab03-e487c2625c58UNII F5UM2KM3W7, 88AYB867L5UPC 0367618183069
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
N467618018306followed by a unit qualifier and the quantityPackage 67618-0183-06. 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 First aid to help prevent infection and relieve pain or discomfort in minor • cuts • scrapes • burns
Excerpt only. Read the full label for complete information.
About NDC 67618-183
- What is NDC 67618-183?
- 67618-183 is the product NDC for Maximum Strength Betadine Clear, Benzalkonium chloride .13 mg/mL; Pramoxine hydrochloride 1 mg/mL spray, listed with the FDA by Atlantis Consumer Healthcare, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Maximum Strength Betadine Clear (Benzalkonium Cl and Pramoxine HCl).
- What is the active ingredient?
- Benzalkonium chloride, Pramoxine hydrochloride.
- Who is the labeler?
- Atlantis Consumer Healthcare, Inc., NDC labeler code 67618. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Maximum Strength Betadine Clear?
- 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 M 003
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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| Hydrogen Peroxide | Hydrogen peroxide 30 mg/mL | SolutionTopical | Grocery Outlet, Inc. | 85828-871 |
| Antiseptic Towelette TOALLITAS ANTISEPTICASbenzalkonium chloride | Benzalkonium chloride 1.3 mg/g | ClothTopical | M-star (Hubei) Health&Care Products Co., Ltd. | 84219-004 |
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