sunmark calamine

Generic: calamine 8% and zinc oxide 8%

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

Drug Facts

Product Profile

Brand Name sunmark calamine
Generic Name calamine 8% and zinc oxide 8%
Labeler strategic sourcing services llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

zinc oxide 160 mg/mL

Manufacturer
Strategic Sourcing Services LLC

Identifiers & Regulatory

Product NDC 49348-011
Product ID 49348-011_0ce55ce7-d70e-5b31-e063-6294a90a7ab7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2008-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49348011
Hyphenated Format 49348-011

Supplemental Identifiers

UPC
0010939148339
UNII
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 calamine (source: ndc)
Generic Name calamine 8% and zinc oxide 8% (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (49348-011-34)
source: ndc

Packages (1)

49348-011-34 177 mL in 1 BOTTLE, PLASTIC (49348-011-34)

Ingredients (1)

zinc oxide (160 mg/mL)

Linked Drug Pages (1)

Sunmark Calamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0ce55ce7-d70e-5b31-e063-6294a90a7ab7", "openfda": {"upc": ["0010939148339"], "unii": ["SOI2LOH54Z"], "spl_set_id": ["c7467f21-56cc-43ca-abfa-e62d35c8baa6"], "manufacturer_name": ["Strategic Sourcing Services LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (49348-011-34)", "package_ndc": "49348-011-34", "marketing_start_date": "20171212"}], "brand_name": "Sunmark Calamine", "product_id": "49348-011_0ce55ce7-d70e-5b31-e063-6294a90a7ab7", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "49348-011", "generic_name": "Calamine 8% and Zinc Oxide 8%", "labeler_name": "Strategic Sourcing Services LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sunmark Calamine", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "160 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20080101", "listing_expiration_date": "20261231"}