humco calagesic

Generic: calamine and pramoxine hydrochloride

Labeler: pharma nobis, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name humco calagesic
Generic Name calamine and pramoxine hydrochloride
Labeler pharma nobis, llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

pramoxine hydrochloride 10 mg/mL, zinc oxide 80 mg/mL

Manufacturer
Pharma Nobis, LLC

Identifiers & Regulatory

Product NDC 82645-922
Product ID 82645-922_0d6ccb8f-d9c0-28e6-e063-6294a90a8a87
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 1998-03-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82645922
Hyphenated Format 82645-922

Supplemental Identifiers

RxCUI
1234532 1234539
UPC
0087701552861 0840986024603 0093351013027 0041415066755 0070038592600
UNII
88AYB867L5 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 humco calagesic (source: ndc)
Generic Name calamine and pramoxine hydrochloride (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • 80 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (82645-922-96)
source: ndc

Packages (1)

Ingredients (2)

pramoxine hydrochloride (10 mg/mL) zinc oxide (80 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "0d6ccb8f-d9c0-28e6-e063-6294a90a8a87", "openfda": {"upc": ["0087701552861", "0840986024603", "0093351013027", "0041415066755", "0070038592600"], "unii": ["88AYB867L5", "SOI2LOH54Z"], "rxcui": ["1234532", "1234539"], "spl_set_id": ["e42fb807-8cb4-ed25-e053-2995a90a6780"], "manufacturer_name": ["Pharma Nobis, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (82645-922-96)", "package_ndc": "82645-922-96", "marketing_start_date": "20171113"}], "brand_name": "Humco Calagesic", "product_id": "82645-922_0d6ccb8f-d9c0-28e6-e063-6294a90a8a87", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "82645-922", "generic_name": "Calamine and Pramoxine Hydrochloride", "labeler_name": "Pharma Nobis, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Humco Calagesic", "active_ingredients": [{"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}, {"name": "ZINC OXIDE", "strength": "80 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19980325", "listing_expiration_date": "20261231"}