What is NDC 70000-0397?

70000-0397 is the product NDC for Calamine Clear, Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL lotion, listed with the FDA by Cardinal Health, 110 dba Leader. 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.

Cardinal Health, 110 dba Leader, NDC labeler code 70000. 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 70000-0397 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70000-0397Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70000-0397Add 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
70000-0397-1	7000003970170000039701	177 mL in 1 BOTTLE, PLASTIC (70000-0397-1)Marketed from Jan 15, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Cardinal Health, 110 dba LeaderNDC labeler code 70000
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 016
Marketing start: Jan 15, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Copper Ion Absorption (Physiologic effect)
Identifiers: Product ID 70000-0397_185584d0-0662-431c-e063-6394a90a4827SPL ID 185584d0-0662-431c-e063-6394a90a4827SPL set ID 7f733c0a-82b2-d3b0-e053-2991aa0a6b0fRxCUI 1234546UNII 88AYB867L5, FM5526K07AUPC 0096295135091
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

N470000039701 followed by a unit qualifier and the quantity

Package 70000-0397-01. 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 May 13, 2024.

Indications (excerpt from the label)

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 70000-0397

What is NDC 70000-0397?: 70000-0397 is the product NDC for Calamine Clear, Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL lotion, listed with the FDA by Cardinal Health, 110 dba Leader. 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?: Cardinal Health, 110 dba Leader, NDC labeler code 70000. 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	Pharma Nobis, LLC	82645-400	82645-0400-96

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
2-Pack Facial Serum	Water 78.894 g/100mL + 4 more ingredients	LiquidCutaneous	Guangzhou Ariel Biotech Co., Ltd.	84148-011
2-Pack Facial Serum	3-o-ethyl ascorbic acid .5 g/100mL + 3 more ingredients	LiquidCutaneous	Guangzhou Ariel Biotech Co., Ltd.	84148-012
3M Cavilon Durable Barrierdimethicone	Dimethicone 13000 mg/L	CreamTopical	Solventum US LLC	17518-030
4% 10gTATTOO Numb Cream4% lidocaine	Lidocaine 100 mg/g	CreamCutaneous	Shengnan (Guangzhou) Cosmetics Co., LTD	84019-031
4% TATTOO Numb Cream4% lidocaine	Lidocaine 100 mg/g	CreamCutaneous	Shengnan (Guangzhou) Cosmetics Co., LTD	84019-030
456 Acne Relief Creamniacinamide,salicylic acid,centella asiatica root,coptis chinensis root	Salicylic acid 380 mg/50g + 3 more ingredients	CreamTopical	Guangzhou Senmai Biotechnology Co.,Ltd.	84509-111
5% Dr.care Numb creamlidocaine	Lidocaine 100 mg/g	CreamCutaneous	Shengnan (Guangzhou) Cosmetics Co., LTD	84019-028
5% Minoxidil	Minoxidil 2 g/100g + 3 more ingredients	SprayCutaneous	Guangzhou Yanxi Biotechnology Co., Ltd	84025-328
5% Minoxidil	Minoxidil 2 g/100g + 3 more ingredients	SprayCutaneous	Guangzhou Yanxi Biotechnology Co., Ltd	84025-329
5% Minoxidil	Biotin .05 g/100g; Niacinamide 2.5 g/100g	SprayCutaneous	Guangzhou Yanxi Biotechnology Co., Ltd	84025-335
5% Minoxidil	Minoxidil 5 g/100g + 5 more ingredients	SprayCutaneous	Guangzhou Yanxi Biotechnology Co., Ltd	84025-337
5% Minoxidil for Men and Women	Biotin .05 g/100g; Tocopherol .05 g/100g	SprayCutaneous	Guangzhou Yanxi Biotechnology Co., Ltd	84025-332
5% Minoxidil Hair Growth	Biotin .1 g/100g + 3 more ingredients	SprayCutaneous	Guangzhou Yanxi Biotechnology Co., Ltd	84025-333
5% Minoxidil Hair Growth	Minoxidil 5 g/100g + 3 more ingredients	SprayCutaneous	Guangzhou Yanxi Biotechnology Co., Ltd	84025-334
5% Signature Numb creamlidocaine	Lidocaine 100 mg/g	CreamCutaneous	Shengnan (Guangzhou) Cosmetics Co., LTD	84019-026
5% Signature Numb cream5% signature	Lidocaine 100 mg/g	CreamCutaneous	Shengnan (Guangzhou) Cosmetics Co., LTD	84019-027
5% Signature Numb cream5% lidocaine	Lidocaine 100 mg/g	CreamCutaneous	Shengnan (Guangzhou) Cosmetics Co., LTD	84019-029
70% Isopropyl Rubbing Alcoholisopropyl alcohol	Isopropyl alcohol 70 mL/100mL	LiquidTopical	MY IMPORTS USA LLC	51628-4501
911allantoin	Allantoin .5 g/100g	OintmentTopical	Skinfix, Inc.	61328-120
A and Dpetrolatum	Petrolatum 76 g/100g	OintmentTopical	Safetec of America, Inc.	61010-4405

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