calamine

Generic: calamine and zinc oxide

Labeler: wal-mart stores, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name calamine
Generic Name calamine and zinc oxide
Labeler wal-mart stores, inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

zinc oxide 160 mg/mL

Manufacturer
Wal-Mart Stores, Inc.

Identifiers & Regulatory

Product NDC 49035-413
Product ID 49035-413_0ce56647-4353-5868-e063-6294a90a8d19
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2017-12-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49035413
Hyphenated Format 49035-413

Supplemental Identifiers

RxCUI
617954
UPC
0681131176002
UNII
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 calamine (source: ndc)
Generic Name calamine and zinc oxide (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (49035-413-96)
source: ndc

Packages (1)

49035-413-96 177 mL in 1 BOTTLE, PLASTIC (49035-413-96)

Ingredients (1)

zinc oxide (160 mg/mL)

Linked Drug Pages (1)

Calamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0ce56647-4353-5868-e063-6294a90a8d19", "openfda": {"upc": ["0681131176002"], "unii": ["SOI2LOH54Z"], "rxcui": ["617954"], "spl_set_id": ["61929c97-bd6b-0d7c-e053-2991aa0aa571"], "manufacturer_name": ["Wal-Mart Stores, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (49035-413-96)", "package_ndc": "49035-413-96", "marketing_start_date": "20171230"}], "brand_name": "Calamine", "product_id": "49035-413_0ce56647-4353-5868-e063-6294a90a8d19", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "49035-413", "generic_name": "Calamine and Zinc Oxide", "labeler_name": "Wal-Mart Stores, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Calamine", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "160 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20171230", "listing_expiration_date": "20261231"}