calamine

Generic: ferric oxide red

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name calamine
Generic Name ferric oxide red
Labeler nucare pharmaceuticals,inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

ferric oxide red 8 g/mL, zinc oxide 8 mg/mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4322
Product ID 68071-4322_1a3dc619-6b13-21b4-e063-6294a90acb1e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2013-01-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680714322
Hyphenated Format 68071-4322

Supplemental Identifiers

RxCUI
617954
UPC
0368071432268
UNII
1K09F3G675 SOI2LOH54Z

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 ferric oxide red (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 8 g/mL
  • 8 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE (68071-4322-6)
source: ndc

Packages (1)

68071-4322-6 177 mL in 1 BOTTLE (68071-4322-6)

Ingredients (2)

ferric oxide red (8 g/mL) zinc oxide (8 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": "1a3dc619-6b13-21b4-e063-6294a90acb1e", "openfda": {"upc": ["0368071432268"], "unii": ["1K09F3G675", "SOI2LOH54Z"], "rxcui": ["617954"], "spl_set_id": ["66e98554-e158-a519-e053-2a91aa0a6783"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (68071-4322-6)", "package_ndc": "68071-4322-6", "marketing_start_date": "20180308"}], "brand_name": "Calamine", "product_id": "68071-4322_1a3dc619-6b13-21b4-e063-6294a90acb1e", "dosage_form": "LOTION", "product_ndc": "68071-4322", "generic_name": "FERRIC OXIDE RED", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Calamine", "active_ingredients": [{"name": "FERRIC OXIDE RED", "strength": "8 g/mL"}, {"name": "ZINC OXIDE", "strength": "8 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130107", "listing_expiration_date": "20261231"}