calmol 4

Generic: zinc oxide and cocoa butter

Labeler: resical inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name calmol 4
Generic Name zinc oxide and cocoa butter
Labeler resical inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

cocoa butter 2052 mg/1, zinc oxide 270 mg/1

Manufacturer
Resical Inc.

Identifiers & Regulatory

Product NDC 67492-104
Product ID 67492-104_41eb9348-e861-4ac7-e063-6294a90a96cf
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2006-05-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67492104
Hyphenated Format 67492-104

Supplemental Identifiers

RxCUI
1049137 1113714
UNII
512OYT1CRR 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 calmol 4 (source: ndc)
Generic Name zinc oxide and cocoa butter (source: ndc)
Application Number M015 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 2052 mg/1
  • 270 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (67492-104-11) / 6 SUPPOSITORY in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (67492-104-12) / 6 SUPPOSITORY in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (67492-104-13) / 2 SUPPOSITORY in 1 BLISTER PACK
source: ndc

Packages (3)

67492-104-11 4 BLISTER PACK in 1 CARTON (67492-104-11) / 6 SUPPOSITORY in 1 BLISTER PACK 67492-104-12 2 BLISTER PACK in 1 CARTON (67492-104-12) / 6 SUPPOSITORY in 1 BLISTER PACK 67492-104-13 1 BLISTER PACK in 1 CARTON (67492-104-13) / 2 SUPPOSITORY in 1 BLISTER PACK

Ingredients (2)

cocoa butter (2052 mg/1) zinc oxide (270 mg/1)

Linked Drug Pages (1)

Calmol 4 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "41eb9348-e861-4ac7-e063-6294a90a96cf", "openfda": {"unii": ["512OYT1CRR", "SOI2LOH54Z"], "rxcui": ["1049137", "1113714"], "spl_set_id": ["5516f800-d3fa-4b90-a3eb-c0bdf3183b9b"], "manufacturer_name": ["Resical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (67492-104-11)  / 6 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "67492-104-11", "marketing_start_date": "20060513"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (67492-104-12)  / 6 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "67492-104-12", "marketing_start_date": "20060513"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (67492-104-13)  / 2 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "67492-104-13", "marketing_start_date": "20060513"}], "brand_name": "Calmol 4", "product_id": "67492-104_41eb9348-e861-4ac7-e063-6294a90a96cf", "dosage_form": "SUPPOSITORY", "product_ndc": "67492-104", "generic_name": "Zinc Oxide and Cocoa Butter", "labeler_name": "Resical Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Calmol 4", "active_ingredients": [{"name": "COCOA BUTTER", "strength": "2052 mg/1"}, {"name": "ZINC OXIDE", "strength": "270 mg/1"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20060513", "listing_expiration_date": "20261231"}