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.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Calamine Clear NDC 82645-400 | National Drug Code

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 NDC	11-digit (billing)	Package	Copy
82645-400-96	8264504009682645040096	177 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: Apr 15, 2026
Listing expires: Dec 31, 2027
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 Apr 15, 2026.

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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Calamine Clearpramoxine hydrochloride and zinc acetate lotion	Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL	LotionTopical	Cardinal Health, 110 dba Leader	70000-0397	70000-0397-01

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
Product	Strength	Form · route	Labeler	Product NDC
Barrier Balmcolloidal oatmeal balm	Oatmeal 1 g/100g	SalveTopical	Tubby Todd	73088-305
Earthmed Lip Balm Pineappleallantoin	Allantoin .045 g/4.455g	SalveTopical	Earthmed LLC	82876-988
Welmedix HomeCare PRO Fragile Skin Protectantpetrolatum	Petrolatum 42 g/100g	OintmentTopical	Welmedix LLC	24330-413
Petroleumwhite petrolatum	Petrolatum 1 g/g	JellyTopical	H E B	37808-015
Pure Petrolatum Jellypetrolatum	Petrolatum 100 g/100g	JellyTopical	MY IMPORTS USA LLC	51628-4600
A and Dpetrolatum	Petrolatum 76 g/100g	OintmentTopical	Safetec of America, Inc.	61010-4405
Dermatitis Face Balmcolloidal oatmeal	Oatmeal 5 g/100g	OintmentTopical	Skinfix, Inc.	61328-121
McKesson Skin Protectantzinc oxide	Zinc oxide 50 mg/mL	CreamTopical	McKesson Medical-Surgical Inc.	68599-5312
All Over Lavender Rosemarycolloidal oat ointment	Oatmeal 1 g/100g	OintmentTopical	Tubby Todd	73088-303
XIMONTH GLP-1 Patchesglycerin	Acetyl hexapeptide-8 amide .006 mg/30mg; Rose oil .006 mg/30mg	PatchTopical	Shantou Ximonth Biotechnology Co., Ltd.	84989-009
Deep Renewal Broad Spectrumdimethicone, avobenzone, homosalate, and octisalate	Dimethicone 2 g/100g + 3 more ingredients	StickTopical	Blistex Inc	10157-1170
Skin Soothing Cream - Nut Freecolloidal oatmeal	Oatmeal 1 mg/g	CreamTopical	Allure Labs	62742-4194
Lavender Scent Petroleumwhite petroleum	Petrolatum 99.9 g/100g	JellyTopical	Jell Pharmaceuticals Pvt Ltd	30400-514
Witch Hazel	Witch hazel 842 mg/mL	LiquidTopical	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	49035-039
Eczema Dermatitis Relief Balmcolloidal oatmeal	Oatmeal 5 g/100g	CreamTopical	Skinfix, Inc.	61328-112
Dovenourishing hand sanitizer sensitive skin 8hr moisturization	Alcohol 610 mg/mL	GelTopical	Conopco Inc. d/b/a/ Unilever	64942-1996
Petroleum Skin Protectantwhite petrolatum	Petrolatum 1 g/g	JellyTopical	Pharmacy Value Alliance, LLC	68016-069
Sweet Cheeks Diaper Sprayerzinc oxide diaper paste spray	Zinc oxide 14.9 g/100g	SprayTopical	Tubby Todd	73088-304
Estrogen Estriol Cream5% estriol	Estriol 5 g/100g	CreamTopical	YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD	83364-026
Earthmed FS massage oilallantoin	Allantoin 1 g/108.48g	OilTopical	Earthmed LLC	82876-986

Showing 20 of 40.