sunmark caldyphen clear

Generic: zinc acetate and pramoxine hydrochloride

Labeler: strategic sourcing services llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sunmark caldyphen clear
Generic Name zinc acetate and pramoxine hydrochloride
Labeler strategic sourcing services llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

pramoxine hydrochloride 10 mg/mL, zinc oxide 80 mg/mL

Manufacturer
Strategic Sourcing Services LLC

Identifiers & Regulatory

Product NDC 49348-610
Product ID 49348-610_0ce5bdec-f4fe-73d9-e063-6294a90a6a87
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 1998-03-25

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49348610
Hyphenated Format 49348-610

Supplemental Identifiers

UPC
0010939146335
UNII
88AYB867L5 SOI2LOH54Z

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sunmark caldyphen clear (source: ndc)
Generic Name zinc acetate and pramoxine hydrochloride (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • 80 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (49348-610-36)
source: ndc

Packages (1)

49348-610-36 177 mL in 1 BOTTLE, PLASTIC (49348-610-36)

Ingredients (2)

pramoxine hydrochloride (10 mg/mL) zinc oxide (80 mg/mL)

Linked Drug Pages (1)

Sunmark Caldyphen Clear ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0ce5bdec-f4fe-73d9-e063-6294a90a6a87", "openfda": {"upc": ["0010939146335"], "unii": ["88AYB867L5", "SOI2LOH54Z"], "spl_set_id": ["329cd4ef-b699-46ff-a5d6-907f7c327c03"], "manufacturer_name": ["Strategic Sourcing Services LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (49348-610-36)", "package_ndc": "49348-610-36", "marketing_start_date": "20171212"}], "brand_name": "Sunmark Caldyphen Clear", "product_id": "49348-610_0ce5bdec-f4fe-73d9-e063-6294a90a6a87", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "49348-610", "generic_name": "Zinc Acetate and Pramoxine Hydrochloride", "labeler_name": "Strategic Sourcing Services LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sunmark Caldyphen Clear", "active_ingredients": [{"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}, {"name": "ZINC OXIDE", "strength": "80 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19980325", "listing_expiration_date": "20261231"}