calamine

Generic: ferric oxide red

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name calamine
Generic Name ferric oxide red
Labeler topco associates llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-063
Product ID 36800-063_4ab7ad96-87b5-6284-e063-6294a90ae847
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2027-12-31
Marketing Start 1991-09-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800063
Hyphenated Format 36800-063

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 ferric oxide red (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 (36800-063-30)
source: ndc

Packages (1)

36800-063-30 177 mL in 1 BOTTLE, PLASTIC (36800-063-30)

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": "4ab7ad96-87b5-6284-e063-6294a90ae847", "openfda": {"unii": ["1K09F3G675", "SOI2LOH54Z"], "rxcui": ["617954"], "spl_set_id": ["2b32e720-ac71-4d60-bc06-e28a00f8a450"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (36800-063-30)", "package_ndc": "36800-063-30", "marketing_start_date": "19910915"}], "brand_name": "Calamine", "product_id": "36800-063_4ab7ad96-87b5-6284-e063-6294a90ae847", "dosage_form": "LOTION", "product_ndc": "36800-063", "generic_name": "FERRIC OXIDE RED", "labeler_name": "Topco Associates 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": "19910915", "listing_expiration_date": "20271231"}