Over-the-counter drug · OTC MONOGRAPH DRUG
Preparation H Cooling Gel (Phenylephrine hcl, witch hazel) NDC 0573-2840
Phenylephrine hydrochloride 2.5 mg/g; Witch hazel 500 mg/g · Gel · Topical · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0573-2840-10 | 00573284010 | 1 TUBE in 1 CARTON (0573-2840-10) / 26 g in 1 TUBEMarketed from Jan 1, 2004 | |
| 0573-2840-20 | 00573284020 | 1 TUBE in 1 CARTON (0573-2840-20) / 51 g in 1 TUBEMarketed from Jan 1, 2004 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Preparation H Cooling Gel
- Generic name (nonproprietary)
- phenylephrine hcl, witch hazel
- Active ingredients
- Phenylephrine hydrochloride — 2.5 mg/gWitch hazel — 500 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Haleon US Holdings LLCNDC labeler code 0573
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 015
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 0573-2840_15581b30-e802-550a-e063-6394a90a3aaeSPL ID 15581b30-e802-550a-e063-6394a90a3aaeSPL set ID cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4RxCUI 249465UNII 04JA59TNSJ, 101I4J0U34
- Pharmacologic class
- alpha-1 Adrenergic Agonist
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
N400573284010followed by a unit qualifier and the quantityPackage 00573-2840-10. 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 hemorrhoids temporary relief of irritation and burning temporarily shrinks hemorrhoidal tissue aids in protecting irritated anorectal areas
Excerpt only. Read the full label for complete information.
About NDC 0573-2840
- What is NDC 0573-2840?
- 0573-2840 is the product NDC for Preparation H Cooling Gel, Phenylephrine hydrochloride 2.5 mg/g; Witch hazel 500 mg/g gel, listed with the FDA by Haleon US Holdings LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Preparation H Cooling Gel (Phenylephrine hcl, witch hazel).
- What is the active ingredient?
- Phenylephrine hydrochloride, Witch hazel.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0573. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Preparation H Cooling Gel?
- 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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