Over-the-counter drug · OTC MONOGRAPH DRUG
Pura (Witch hazel) NDC 84217-050
Witch hazel 50 mg/1 · Cloth · Topical · Mypura.com Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84217-050-48 | 84217005048 | 48 PATCH in 1 BOX (84217-050-48) / 1 CLOTH in 1 PATCHMarketed from Apr 2, 2024 |
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)
- Pura
- Generic name (nonproprietary)
- witch hazel
- Active ingredients
- Witch hazel — 50 mg/1
- Dosage form
- Cloth
- Route
- Topical
- Labeler
- Mypura.com LimitedNDC labeler code 84217
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 015
- Marketing start
- Listing expires
- Identifiers
- Product ID 84217-050_453a5aea-e8d8-e6f9-e063-6294a90a9ad9SPL ID 453a5aea-e8d8-e6f9-e063-6294a90a9ad9SPL set ID 1523f52f-6a5b-a12d-e063-6294a90a4496RxCUI 844379UNII 101I4J0U34
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
N484217005048followed by a unit qualifier and the quantityPackage 84217-0050-48. 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 helps relieve the local itching and discomfort associated with hemmorhoids temporary relief of irritation and burning aids in protecting irritated anorectal areas
Excerpt only. Read the full label for complete information.
About NDC 84217-050
- What is NDC 84217-050?
- 84217-050 is the product NDC for Pura (witch hazel), Witch hazel 50 mg/1 cloth, listed with the FDA by Mypura.com Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pura (Witch Hazel).
- What is the active ingredient?
- Witch hazel.
- Who is the labeler?
- Mypura.com Limited, NDC labeler code 84217. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pura?
- 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 015
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 |
|---|---|---|---|---|
| 0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-094 |
| 0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Universal Distribution Center LLC | 52000-438 |
| 5% Lidocaine 10g5% lidocaine | Lidocaine 5 g/100g | CreamTopical | Chongqing Mandongzi Technology Co., Ltd | 88002-001 |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangzhou Haishi Biological Technology Co., Ltd. | 60771-0028 |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangzhou Haishi Biological Technology Co., Ltd. | 60771-0029 |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-615 |
| Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangzhou Haishi Biological Technology Co., Ltd. | 60771-0041 |
| Adellina Lidocaine Numbing Cream Topical Anorectal Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-612 |
| Adellina Lidocaine Numbing Cream Topical Anorectal Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-614 |
| ADVANCED NUMB Topical Anestheticlidocaine hydrochloride | Lidocaine hydrochloride 50 mg/g | CreamTopical | Uber Scientific, LLC | 71131-052 |
| AER Pre-moistened Witch Hazel Padwitch hazel | Witch hazel 500 mg/mL | SolutionRectal, Topical | Birchwood Laboratories LLC | 50289-3250 |
| AER Traveler Toweletteaer traveler | Witch hazel .5 g/1 | SolutionRectal, Topical | Birchwood Laboratories LLC | 50289-4200 |
| Americainebenzocaine | Benzocaine 5.6 g/28g | OintmentTopical | Insight Pharmaceuticals LLC | 63736-375 |
| AnievaLClidocaine | Lidocaine .05 g/g | CreamTopical | Blackstone Products, LLC | 87798-001 |
| ANIXIKE Numbinglidocaine4% numbing | Lidocaine 4 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-166 |
| Arlun LIDOCAINE Creamlidocaine cream | Lidocaine 5 g/100g | CreamTopical | Guangzhou Jingliang Cosmetics Co., Ltd. | 87408-021 |
| Assured Bikini Smooth Creamlidocaine | Lidocaine 2 g/100g | CreamTopical | Zhejiang Jingwei Pharmaceutical Co., Ltd. | 55621-011 |
| Asteroidmenthol, petrolatum, zinc oxide | Menthol .098 g/28g + 2 more ingredients | OintmentTopical | HEALTHTEX LIMITED | 84107-552 |
| B-SURE Traveler Toweletteb-sure traveler | Witch hazel .5 g/g | SolutionRectal, Topical | Birchwood Laboratories LLC | 50289-9250 |
| Barrier Protectant Creambarrier cream | Menthol 1 mg/g; Zinc oxide 200 mg/g | OintmentTopical | Cardinal Health | 63517-003 |
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