Over-the-counter drug · OTC MONOGRAPH DRUG
Divine Dandrene 2% (Zinc pyrithione) NDC 69188-200
Pyrithione zinc 2 g/100mL · Shampoo · Topical · DS Healthcare Group, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69188-200-07 | 6918802000769188020007 | 205 mL in 1 BOTTLE, PLASTIC (69188-200-07)Marketed from Jun 1, 2021 |
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)
- Divine Dandrene 2%
- Generic name (nonproprietary)
- zinc pyrithione
- Active ingredients
- Pyrithione zinc — 2 g/100mL
- Dosage form
- Shampoo
- Route
- Topical
- Labeler
- DS Healthcare Group, Inc.NDC labeler code 69188
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 032
- Marketing start
- Listing expires
- Identifiers
- Product ID 69188-200_4354ea0a-3cff-5938-e063-6294a90ad156SPL ID 4354ea0a-3cff-5938-e063-6294a90ad156SPL set ID 54b0a610-dd15-4064-9feb-4d30b5e522adRxCUI 244458, 2059178UNII R953O2RHZ5
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
N469188020007followed by a unit qualifier and the quantityPackage 69188-0200-07. 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 Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling associated with dandruff
Excerpt only. Read the full label for complete information.
About NDC 69188-200
- What is NDC 69188-200?
- 69188-200 is the product NDC for Divine Dandrene 2% (zinc pyrithione), Pyrithione zinc 2 g/100mL shampoo, listed with the FDA by DS Healthcare Group, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Divine Dandrene 2% (Zinc Pyrithione).
- What is the active ingredient?
- Pyrithione zinc.
- Who is the labeler?
- DS Healthcare Group, Inc., NDC labeler code 69188. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Divine Dandrene 2%?
- 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 032
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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