calamine

Generic: calamine and zinc oxide

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

Drug Facts

Product Profile

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

ferric oxide red 80 mg/mL, zinc oxide 80 mg/mL

Manufacturer
Strategic Sourcing Services, LLC

Identifiers & Regulatory

Product NDC 70677-1196
Product ID 70677-1196_22171fc2-2953-3ed2-e063-6294a90af4a2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2024-09-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 706771196
Hyphenated Format 70677-1196

Supplemental Identifiers

RxCUI
617954
UNII
1K09F3G675 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 calamine (source: ndc)
Generic Name calamine and zinc oxide (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (70677-1196-1)
source: ndc

Packages (1)

70677-1196-1 177 mL in 1 BOTTLE, PLASTIC (70677-1196-1)

Ingredients (2)

ferric oxide red (80 mg/mL) zinc oxide (80 mg/mL)

Linked Drug Pages (1)

Calamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "22171fc2-2953-3ed2-e063-6294a90af4a2", "openfda": {"unii": ["1K09F3G675", "SOI2LOH54Z"], "rxcui": ["617954"], "spl_set_id": ["22173332-9d09-768c-e063-6394a90a94e1"], "manufacturer_name": ["Strategic Sourcing Services, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (70677-1196-1)", "package_ndc": "70677-1196-1", "marketing_start_date": "20240914"}], "brand_name": "Calamine", "product_id": "70677-1196_22171fc2-2953-3ed2-e063-6294a90af4a2", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "70677-1196", "generic_name": "Calamine and Zinc Oxide", "labeler_name": "Strategic Sourcing Services, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Calamine", "active_ingredients": [{"name": "FERRIC OXIDE RED", "strength": "80 mg/mL"}, {"name": "ZINC OXIDE", "strength": "80 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240914", "listing_expiration_date": "20261231"}