Over-the-counter drug · OTC MONOGRAPH DRUG
Caladryl Clear (Pramoxine hydrochloride and zinc acetate) NDC 0187-5466
Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL · Lotion · Topical · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-5466-06 | 0018754660600187546606 | 177 mL in 1 BOTTLE, PLASTIC (0187-5466-06)Marketed from Aug 16, 2013 |
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)
- Caladryl Clear
- Generic name (nonproprietary)
- pramoxine hydrochloride and zinc acetate
- Active ingredients
- Pramoxine hydrochloride — 10 mg/mLZinc acetate — 1 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Bausch Health US, LLCNDC labeler code 0187
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Copper Ion Absorption (Physiologic effect)
- Identifiers
- Product ID 0187-5466_24adc674-5fba-e779-e063-6294a90ad250SPL ID 24adc674-5fba-e779-e063-6294a90ad250SPL set ID fca6f08b-7fa0-4ae6-bce3-61f3bcae4332RxCUI 1234546, 1234552UNII 88AYB867L5, FM5526K07AUPC 0301875466060
- Pharmacologic class
- Copper Absorption Inhibitor
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
N400187546606followed by a unit qualifier and the quantityPackage 00187-5466-06. 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 temporarily relieves pain and itching associated with: rashes due to poison ivy, poison oak or poison sumac insect bites minor skin irritation minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac
Excerpt only. Read the full label for complete information.
About NDC 0187-5466
- What is NDC 0187-5466?
- 0187-5466 is the product NDC for Caladryl Clear, Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL lotion, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Caladryl Clear (PRAMOXINE HYDROCHLORIDE and ZINC ACETATE).
- What is the active ingredient?
- Pramoxine hydrochloride, Zinc acetate.
- Who is the labeler?
- Bausch Health US, LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Caladryl 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 014
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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