NDC 67492-104

Calmol 4

Zinc Oxide And Cocoa Butter

Calmol 4 is a Rectal Suppository in the Human Otc Drug category. It is labeled and distributed by Resical Inc.. The primary component is Zinc Oxide; Cocoa Butter.

Product ID67492-104_7c4d0077-3102-cb52-e053-2a91aa0a2a3b
NDC67492-104
Product TypeHuman Otc Drug
Proprietary NameCalmol 4
Generic NameZinc Oxide And Cocoa Butter
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2006-05-13
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameResical Inc.
Substance NameZINC OXIDE; COCOA BUTTER
Active Ingredient Strength270 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67492-104-11

4 BLISTER PACK in 1 CARTON (67492-104-11) > 6 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date2006-05-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67492-104-13 [67492010413]

Calmol 4 SUPPOSITORY
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-05-13

NDC 67492-104-12 [67492010412]

Calmol 4 SUPPOSITORY
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-05-13

NDC 67492-104-11 [67492010411]

Calmol 4 SUPPOSITORY
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-05-13

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE270 mg/1

OpenFDA Data

SPL SET ID:5516f800-d3fa-4b90-a3eb-c0bdf3183b9b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1113714
  • 1049137
  • UPC Code
  • 0367492104112
  • NDC Crossover Matching brand name "Calmol 4" or generic name "Zinc Oxide And Cocoa Butter"

    NDCBrand NameGeneric Name
    67492-104Calmol 4Zinc Oxide and Cocoa Butter
    54866-001AVERTEAXzinc oxide and Cocoa Butter
    54866-003AVERTEAXzinc oxide and Cocoa Butter

    Trademark Results [Calmol 4]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CALMOL 4
    CALMOL 4
    72237150 0820221 Live/Registered
    CHAS. PFIZER & CO., INC.
    1966-01-24

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