NDC codes

FDA NDC Directory
Product NDC (as listed)0187-5465Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00187-5465Add 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
0187-5465-060018754650600187546506177 mL in 1 BOTTLE, PLASTIC (0187-5465-06)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
Generic name (nonproprietary)
ferric oxide red, zinc oxide, and pramoxine hydrochloride
Active ingredients
Ferric oxide red — 1.36 mg/mLZinc oxide — 78.65 mg/mLPramoxine hydrochloride — 10 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
Identifiers
Product ID 0187-5465_24add3ce-a1f0-0b6a-e063-6394a90a77c2SPL ID 24add3ce-a1f0-0b6a-e063-6394a90a77c2SPL set ID 67d4fd42-9fed-4238-9f5a-c9403abbcf20RxCUI 1234532, 1234533UNII 1K09F3G675, SOI2LOH54Z, 88AYB867L5UPC 0301875465063

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

N400187546506 followed by a unit qualifier and the quantity

Package 00187-5465-06. 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 0187-5465

What is NDC 0187-5465?
0187-5465 is the product NDC for Caladryl, Ferric oxide red 1.36 mg/mL + 2 more ingredients 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 (Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride).
What is the active ingredient?
Ferric oxide red, Zinc oxide, Pramoxine hydrochloride.
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?
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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ClearCanal Ear Wax Softerner Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)NeilMed Pharmaceuticals, Inc.13709-230
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Clinere Ear Wax Removercarbamide peroxideCarbamide peroxide .065 g/mLLiquidAuricular (Otic)Quest Products68229-102

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