Over-the-counter drug · OTC MONOGRAPH DRUG
Preparation H Soothing Relief Anti-Itch (Hydrocortisone) NDC 0573-0552
Hydrocortisone 10 mg/g · Cream · Topical · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0573-0552-11 | 00573055211 | 1 TUBE in 1 CARTON (0573-0552-11) / 26 g in 1 TUBEMarketed from Feb 28, 2020 |
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 Soothing Relief Anti-Itch
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 10 mg/g
- Dosage form
- Cream
- 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
- Marketing end
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0573-0552_395a1c1c-351c-0fcf-e063-6394a90a3b6eSPL ID 395a1c1c-351c-0fcf-e063-6394a90a3b6eSPL set ID d6148d77-ef6f-4552-b5ba-43b429923f19RxCUI 310868UNII WI4X0X7BPJ
- Pharmacologic class
- Corticosteroid
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
N400573055211followed by a unit qualifier and the quantityPackage 00573-0552-11. 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 temporary relief of external anal itching temporary relief of itching associated with minor skin irritations and rashes other uses of this product should be only under the advice and supervision of a doctor
Excerpt only. Read the full label for complete information.
About NDC 0573-0552
- What is NDC 0573-0552?
- 0573-0552 is the product NDC for Preparation H Soothing Relief Anti-Itch, Hydrocortisone 10 mg/g cream, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Preparation H Soothing Relief Anti-Itch (Hydrocortisone).
- What is the active ingredient?
- Hydrocortisone.
- 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 Soothing Relief Anti-Itch?
- 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.
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| 0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Universal Distribution Center LLC | 52000-438 |
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| Arlun LIDOCAINE Creamlidocaine cream | Lidocaine 5 g/100g | CreamTopical | Guangzhou Jingliang Cosmetics Co., Ltd. | 87408-021 |
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| 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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