sunmark caldiphen

Generic: calamine and pramoxine hydrochloride

Labeler: strategic sourcing services
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sunmark caldiphen
Generic Name calamine and pramoxine hydrochloride
Labeler strategic sourcing services
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Strategic Sourcing Services

Identifiers & Regulatory

Product NDC 49348-337
Product ID 49348-337_0ec0504c-907b-15fa-e063-6294a90a871f
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 49348337
Hyphenated Format 49348-337

Supplemental Identifiers

RxCUI
1234532
UPC
0010939145338
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 sunmark caldiphen (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 (49348-337-36)
source: ndc

Packages (1)

49348-337-36 177 mL in 1 BOTTLE, PLASTIC (49348-337-36)

Ingredients (2)

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

Linked Drug Pages (1)

Sunmark Caldiphen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0ec0504c-907b-15fa-e063-6294a90a871f", "openfda": {"upc": ["0010939145338"], "unii": ["88AYB867L5", "SOI2LOH54Z"], "rxcui": ["1234532"], "spl_set_id": ["4f4d4c54-64b5-4e20-bed0-c7fb470b8434"], "manufacturer_name": ["Strategic Sourcing Services"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (49348-337-36)", "package_ndc": "49348-337-36", "marketing_start_date": "20140402"}], "brand_name": "Sunmark Caldiphen", "product_id": "49348-337_0ec0504c-907b-15fa-e063-6294a90a871f", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "49348-337", "generic_name": "Calamine and Pramoxine Hydrochloride", "labeler_name": "Strategic Sourcing Services", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sunmark Caldiphen", "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"}