calamine

Generic: calamine, pramoxine hcl

Labeler: chain drug marketing association
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name calamine
Generic Name calamine, pramoxine hcl
Labeler chain drug marketing association
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

ferric oxide red 80 mg/mL, pramoxine hydrochloride 10 mg/mL

Manufacturer
Chain Drug Marketing Association

Identifiers & Regulatory

Product NDC 83324-053
Product ID 83324-053_4bcf72e3-68ba-8e7d-e063-6294a90a7536
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2027-12-31
Marketing Start 2025-02-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83324053
Hyphenated Format 83324-053

Supplemental Identifiers

RxCUI
1234532
UNII
1K09F3G675 88AYB867L5

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, pramoxine hcl (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/mL
  • 10 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (83324-053-06)
source: ndc

Packages (1)

83324-053-06 177 mL in 1 BOTTLE, PLASTIC (83324-053-06)

Ingredients (2)

ferric oxide red (80 mg/mL) pramoxine hydrochloride (10 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": "4bcf72e3-68ba-8e7d-e063-6294a90a7536", "openfda": {"unii": ["1K09F3G675", "88AYB867L5"], "rxcui": ["1234532"], "spl_set_id": ["6c848b98-f01c-40f2-a9aa-2af76cb370c8"], "manufacturer_name": ["Chain Drug Marketing Association"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (83324-053-06)", "package_ndc": "83324-053-06", "marketing_start_date": "20250226"}], "brand_name": "Calamine", "product_id": "83324-053_4bcf72e3-68ba-8e7d-e063-6294a90a7536", "dosage_form": "LOTION", "product_ndc": "83324-053", "generic_name": "Calamine, Pramoxine HCl", "labeler_name": "Chain Drug Marketing Association", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Calamine", "active_ingredients": [{"name": "FERRIC OXIDE RED", "strength": "80 mg/mL"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250226", "listing_expiration_date": "20271231"}