Over-the-counter drug · OTC MONOGRAPH DRUG
Caladryl Clear NDC 0187-5466
pramoxine hydrochloride and zinc acetate · 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 | 00187546606 | 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, LLC
- 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.
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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| DISCOUNT drug mart FOOD FAIR earwax removal kitcarbamide peroxide | Carbamide peroxide 65 mg/mL | SolutionTopical | Discount Drug Mart | 53943-835 |
| Dri-Ear | Isopropyl alcohol 950 mg/mL | Suspension/ dropsAuricular (Otic) | S.S.S. Company | 12258-153 |
| LEADER Ear Drops for Swimmers | Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | Cardinal Health, 110 dba Leader | 70000-0478 |
| Discount Drug Mart Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Discount Drug Mart | 53943-838 |
| Family Care Earwax Removalcarbamide peroxide | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | United Exchange Corp. | 65923-639 |
| CaseysDishwashingSoapdishwashing detergent juniper forest | Chloroxylenol .2 g/100g | LiquidCutaneous, Topical | KYNC DESIGN LLC | 76557-050 |
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| Harris Teeter Earwax Removal Dropscarbamide peroxide 6.5% | Carbamide peroxide 6.5 g/100mL | LiquidTopical | Harris Teeter LLC | 69256-117 |
| Hand Sanitizing with Lavender Oilalcohol | Alcohol 62 mL/100mL | GelTopical | PureTek Corporation | 59088-413 |
| ear dropscarbamide peroxide 6.5% | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | Bionpharma Inc. | 69452-377 |
| Family Wellness Earwax Removal Earwax and Bulbcarbamide peroxide | — | Kit | Family Dollar Services Inc | 55319-835 |
| Freskaro Earwax Removal Aidcarbamide peroxide 6.50% kit | Carbamide peroxide 6.5 g/100mL | LiquidAuricular (Otic) | Pharma Nobis, LLC | 82645-097 |
| Ear Wax Removal Drops Up and Upcarbamide peroxide - 6.5% | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | Target Corporation | 11673-761 |
| Freskaro Ear Drops for Swimmers | Glycerin 50 mg/mL; Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | Pharma Nobis, LLC | 82645-098 |
| Clinere Ear Wax Removercarbamide peroxide | Carbamide peroxide .065 g/mL | LiquidAuricular (Otic) | Quest Products | 68229-102 |
| XIMONTH Wart Removerglycerin | Artemisia vulgaris root .004 mg/20mg + 2 more ingredients | OintmentTopical | Shantou Ximonth Biotechnology Co., Ltd. | 84989-004 |
| Earwax Removal Dropscarbamide peroxide 6.5% | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | Pharma Nobis, LLC | 82645-910 |
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