calaclear

Generic: pramoxine hydrochloride and zinc acetate

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

Drug Facts

Product Profile

Brand Name calaclear
Generic Name pramoxine hydrochloride and zinc acetate
Labeler pharma nobis, llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Pharma Nobis, LLC

Identifiers & Regulatory

Product NDC 82645-923
Product ID 82645-923_0d6cc629-bac0-1229-e063-6294a90a2610
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 82645923
Hyphenated Format 82645-923

Supplemental Identifiers

RxCUI
1234546 1248193
UPC
0840986012976 0072036987259 0036800443402 0681131176019 0070038200529 0087701400452 0010939146335 0041220797950 0041415067752 0050428290880 0093351013645
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 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 (82645-923-96)
source: ndc

Packages (1)

82645-923-96 177 mL in 1 BOTTLE, PLASTIC (82645-923-96)

Ingredients (2)

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

Linked Drug Pages (1)

Calaclear ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0d6cc629-bac0-1229-e063-6294a90a2610", "openfda": {"upc": ["0840986012976", "0072036987259", "0036800443402", "0681131176019", "0070038200529", "0087701400452", "0010939146335", "0041220797950", "0041415067752", "0050428290880", "0093351013645"], "unii": ["88AYB867L5", "FM5526K07A"], "rxcui": ["1234546", "1248193"], "spl_set_id": ["e42fccc2-1b4e-e7f3-e053-2a95a90aef39"], "manufacturer_name": ["Pharma Nobis, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (82645-923-96)", "package_ndc": "82645-923-96", "marketing_start_date": "19980325"}], "brand_name": "Calaclear", "product_id": "82645-923_0d6cc629-bac0-1229-e063-6294a90a2610", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "82645-923", "generic_name": "Pramoxine Hydrochloride and Zinc Acetate", "labeler_name": "Pharma Nobis, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "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"}