What is NDC 49348-610?

49348-610 is the product NDC for Sunmark Caldyphen Clear, Zinc oxide 80 mg/mL; Pramoxine hydrochloride 10 mg/mL lotion, listed with the FDA by Strategic Sourcing Services LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Sunmark Caldyphen Clear (Zinc Acetate and Pramoxine Hydrochloride).

What is the active ingredient?

Zinc oxide, Pramoxine hydrochloride.

Strategic Sourcing Services LLC, NDC labeler code 49348. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sunmark Caldyphen 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.

Sunmark Caldyphen Clear NDC 49348-610

NDC codes

FDA NDC Directory

Product NDC (as listed)49348-610Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49348-0610Add 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
49348-610-36	4934806103649348061036	177 mL in 1 BOTTLE, PLASTIC (49348-610-36)Marketed from Dec 12, 2017

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): Sunmark Caldyphen Clear
Generic name (nonproprietary): zinc acetate and pramoxine hydrochloride
Active ingredients: Zinc oxide — 80 mg/mLPramoxine hydrochloride — 10 mg/mL
Dosage form: Lotion
Route: Topical
Labeler: Strategic Sourcing Services LLCNDC labeler code 49348
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 016
Marketing start: Mar 25, 1998
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Copper Ion Absorption (Physiologic effect)
Identifiers: Product ID 49348-610_0ce5bdec-f4fe-73d9-e063-6294a90a6a87SPL ID 0ce5bdec-f4fe-73d9-e063-6294a90a6a87SPL set ID 329cd4ef-b699-46ff-a5d6-907f7c327c03UNII SOI2LOH54Z, 88AYB867L5UPC 0010939146335
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

N449348061036 followed by a unit qualifier and the quantity

Package 49348-0610-36. 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 Dec 19, 2023.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49348-610

What is NDC 49348-610?: 49348-610 is the product NDC for Sunmark Caldyphen Clear, Zinc oxide 80 mg/mL; Pramoxine hydrochloride 10 mg/mL lotion, listed with the FDA by Strategic Sourcing Services LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sunmark Caldyphen Clear (Zinc Acetate and Pramoxine Hydrochloride).
What is the active ingredient?: Zinc oxide, Pramoxine hydrochloride.
Who is the labeler?: Strategic Sourcing Services LLC, NDC labeler code 49348. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sunmark Caldyphen 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 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

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Sunmark Caldyphen Clear (Zinc acetate and pramoxine hydrochloride) NDC 49348-610