humco calaclear

Generic: pramoxine hydrochloride and zinc acetate

Labeler: humco holding group, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name humco calaclear
Generic Name pramoxine hydrochloride and zinc acetate
Labeler humco holding group, inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

pramoxine hydrochloride 10 mg/mL, zinc acetate 1 mg/mL

Manufacturer
Humco Holding Group, Inc.

Identifiers & Regulatory

Product NDC 0395-0400
Product ID 0395-0400_0c929258-b193-bc2f-e063-6394a90a8e47
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 03950400
Hyphenated Format 0395-0400

Supplemental Identifiers

RxCUI
1234546 1248193
UPC
0303950400969
UNII
88AYB867L5 FM5526K07A

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 calaclear (source: ndc)
Generic Name pramoxine hydrochloride and zinc acetate (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • 1 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (0395-0400-96)
source: ndc

Packages (1)

0395-0400-96 177 mL in 1 BOTTLE, PLASTIC (0395-0400-96)

Ingredients (2)

pramoxine hydrochloride (10 mg/mL) zinc acetate (1 mg/mL)

Linked Drug Pages (1)

Humco Calaclear ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0c929258-b193-bc2f-e063-6394a90a8e47", "openfda": {"upc": ["0303950400969"], "unii": ["88AYB867L5", "FM5526K07A"], "rxcui": ["1234546", "1248193"], "spl_set_id": ["5fca3a73-6d66-496b-bd33-6e044f9039bc"], "manufacturer_name": ["Humco Holding Group, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (0395-0400-96)", "package_ndc": "0395-0400-96", "marketing_start_date": "19980325"}], "brand_name": "Humco Calaclear", "product_id": "0395-0400_0c929258-b193-bc2f-e063-6394a90a8e47", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "0395-0400", "generic_name": "Pramoxine Hydrochloride and Zinc Acetate", "labeler_name": "Humco Holding Group, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Humco Calaclear", "active_ingredients": [{"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}, {"name": "ZINC ACETATE", "strength": "1 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19980325", "listing_expiration_date": "20261231"}