NDC codes

FDA NDC Directory
Product NDC (as listed)0187-5466Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00187-5466Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0187-5466-060018754660600187546606177 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

N400187546606 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under M 014
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Auro Driisopropyl alcoholIsopropyl alcohol 95 mL/100mLLiquidAuricular (Otic)Insight Pharmaceuticals LLC63736-327
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blue goo NERVE EASE Pain RELIEF Topical Analgesiclidocaine hcl 4%, menthol 1%Lidocaine 40 mg/mL; Menthol 10 mg/mLLiquidTopicalGarcoa, Inc.67385-825
Bodyographypro Anti-Bacterial Sanitizingethyl alcoholAlcohol 60 mL/100mLSprayTopicalRobanda International, Inc.53950-6010
Caladrylferric oxide red, zinc oxide, and pramoxine hydrochlorideFerric oxide red 1.36 mg/mL + 2 more ingredientsLotionTopicalBausch Health US, LLC0187-5465
Carbamide peroxide 6.5%earwax removal kitCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)Allegiant Health69168-488
CareOne Earwax Removal Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)Retail Business Services, LLC72476-838
CaseysDishwashingSoapdishwashing detergent juniper forestChloroxylenol .2 g/100gLiquidCutaneous, TopicalKYNC DESIGN LLC76557-050
CaseysLavendercaseys hand soap lavender scentBenzalkonium chloride .13 g/100gLiquidTopicalKYNC Design LLC76557-051
ClearCanal Ear Wax Softerner Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)NeilMed Pharmaceuticals, Inc.13709-230
Clearcanal Ear Wax Softerner Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)A-S Medication Solutions50090-7426
Clinere Ear Wax Removercarbamide peroxideCarbamide peroxide .065 g/mLLiquidAuricular (Otic)Quest Products68229-102

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