NDC codes

FDA NDC Directory
Product NDC (as listed)82645-400Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82645-0400Add 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
82645-400-968264504009682645040096177 mL in 1 BOTTLE, PLASTIC (82645-400-96)Marketed from Apr 15, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Calamine Clear
Generic name (nonproprietary)
pramoxine hydrochloride and zinc acetate lotion
Active ingredients
Pramoxine hydrochloride — 10 mg/mLZinc acetate — 1 mg/mL
Dosage form
Lotion
Route
Topical
Labeler
Pharma Nobis, LLCNDC labeler code 82645
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 016
Marketing start
Listing expires
Other FDA classes
Decreased Copper Ion Absorption (Physiologic effect)
Identifiers
Product ID 82645-400_4f852c10-3978-1f04-e063-6394a90a5c1dSPL ID 4f852c10-3978-1f04-e063-6394a90a5c1dSPL set ID 4f853183-5925-2c73-e063-6394a90adf6cRxCUI 1234546UNII 88AYB867L5, FM5526K07AUPC 0382645400965
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

N482645040096 followed by a unit qualifier and the quantity

Package 82645-0400-96. 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)

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82645-400

What is NDC 82645-400?
82645-400 is the product NDC for Calamine Clear, Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL lotion, listed with the FDA by Pharma Nobis, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Calamine Clear (Pramoxine Hydrochloride and Zinc Acetate Lotion).
What is the active ingredient?
Pramoxine hydrochloride, Zinc acetate.
Who is the labeler?
Pharma Nobis, LLC, NDC labeler code 82645. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Calamine Clear?
1 other product NDC are listed under this name. See all Calamine Clear NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Calamine Clear NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Calamine Clearpramoxine hydrochloride and zinc acetate lotionPramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mLLotionTopicalCardinal Health, 110 dba Leader70000-039770000-0397-01

Other NDCs under M 016

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 016
ProductStrengthForm · routeLabelerProduct NDC
2-Pack Facial SerumWater 78.894 g/100mL + 4 more ingredientsLiquidCutaneousGuangzhou Ariel Biotech Co., Ltd.84148-011
2-Pack Facial Serum3-o-ethyl ascorbic acid .5 g/100mL + 3 more ingredientsLiquidCutaneousGuangzhou Ariel Biotech Co., Ltd.84148-012
3M Cavilon Durable BarrierdimethiconeDimethicone 13000 mg/LCreamTopicalSolventum US LLC17518-030
4% 10gTATTOO Numb Cream4% lidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-031
4% TATTOO Numb Cream4% lidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-030
456 Acne Relief Creamniacinamide,salicylic acid,centella asiatica root,coptis chinensis rootSalicylic acid 380 mg/50g + 3 more ingredientsCreamTopicalGuangzhou Senmai Biotechnology Co.,Ltd.84509-111
5% Dr.care Numb creamlidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-028
5% MinoxidilMinoxidil 2 g/100g + 3 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-328
5% MinoxidilMinoxidil 2 g/100g + 3 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-329
5% MinoxidilBiotin .05 g/100g; Niacinamide 2.5 g/100gSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-335
5% MinoxidilMinoxidil 5 g/100g + 5 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-337
5% Minoxidil for Men and WomenBiotin .05 g/100g; Tocopherol .05 g/100gSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-332
5% Minoxidil Hair GrowthBiotin .1 g/100g + 3 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-333
5% Minoxidil Hair GrowthMinoxidil 5 g/100g + 3 more ingredientsSprayCutaneousGuangzhou Yanxi Biotechnology Co., Ltd84025-334
5% Signature Numb creamlidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-026
5% Signature Numb cream5% signatureLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-027
5% Signature Numb cream5% lidocaineLidocaine 100 mg/gCreamCutaneousShengnan (Guangzhou) Cosmetics Co., LTD84019-029
70% Isopropyl Rubbing Alcoholisopropyl alcoholIsopropyl alcohol 70 mL/100mLLiquidTopicalMY IMPORTS USA LLC51628-4501
911allantoinAllantoin .5 g/100gOintmentTopicalSkinfix, Inc.61328-120
A and DpetrolatumPetrolatum 76 g/100gOintmentTopicalSafetec of America, Inc.61010-4405

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