calaclear

Generic: pramoxine hydrochloride and zinc acetate

Labeler: wal-mart stores, inc.
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 wal-mart stores, inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Wal-Mart Stores, Inc.

Identifiers & Regulatory

Product NDC 49035-402
Product ID 49035-402_0ce5624e-220b-3882-e063-6294a90a1827
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2018-01-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49035402
Hyphenated Format 49035-402

Supplemental Identifiers

RxCUI
1234546 1248193
UPC
0681131176019
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 (49035-402-96)
source: ndc

Packages (1)

49035-402-96 177 mL in 1 BOTTLE, PLASTIC (49035-402-96)

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": "0ce5624e-220b-3882-e063-6294a90a1827", "openfda": {"upc": ["0681131176019"], "unii": ["88AYB867L5", "FM5526K07A"], "rxcui": ["1234546", "1248193"], "spl_set_id": ["61e76e2a-fc46-7a64-e053-2991aa0a56a8"], "manufacturer_name": ["Wal-Mart Stores, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (49035-402-96)", "package_ndc": "49035-402-96", "marketing_start_date": "20180103"}], "brand_name": "Calaclear", "product_id": "49035-402_0ce5624e-220b-3882-e063-6294a90a1827", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "49035-402", "generic_name": "Pramoxine Hydrochloride and Zinc Acetate", "labeler_name": "Wal-Mart Stores, Inc.", "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": "20180103", "listing_expiration_date": "20261231"}