sunmark phenolated calamine

Generic: calamine and zinc oxide and phenol

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

Drug Facts

Product Profile

Brand Name sunmark phenolated calamine
Generic Name calamine and zinc oxide and phenol
Labeler strategic sourcing services llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

phenol 10 mg/mL, zinc oxide 160 mg/mL

Manufacturer
Strategic Sourcing Services LLC

Identifiers & Regulatory

Product NDC 49348-802
Product ID 49348-802_0ce5c95c-a899-9b32-e063-6294a90a86b9
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 49348802
Hyphenated Format 49348-802

Supplemental Identifiers

RxCUI
991369
UPC
0010939147332
UNII
339NCG44TV 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 phenolated calamine (source: ndc)
Generic Name calamine and zinc oxide and phenol (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • 160 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (49348-802-34)
source: ndc

Packages (1)

49348-802-34 177 mL in 1 BOTTLE, PLASTIC (49348-802-34)

Ingredients (2)

phenol (10 mg/mL) zinc oxide (160 mg/mL)

Linked Drug Pages (1)

Sunmark Phenolated Calamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0ce5c95c-a899-9b32-e063-6294a90a86b9", "openfda": {"upc": ["0010939147332"], "unii": ["339NCG44TV", "SOI2LOH54Z"], "rxcui": ["991369"], "spl_set_id": ["8e68efc4-4c95-41c0-9fed-32297b1b2edc"], "manufacturer_name": ["Strategic Sourcing Services LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (49348-802-34)", "package_ndc": "49348-802-34", "marketing_start_date": "20171212"}], "brand_name": "Sunmark Phenolated Calamine", "product_id": "49348-802_0ce5c95c-a899-9b32-e063-6294a90a86b9", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "49348-802", "generic_name": "Calamine and Zinc Oxide and Phenol", "labeler_name": "Strategic Sourcing Services LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sunmark Phenolated Calamine", "active_ingredients": [{"name": "PHENOL", "strength": "10 mg/mL"}, {"name": "ZINC OXIDE", "strength": "160 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19980325", "listing_expiration_date": "20261231"}