NDC 0799-0001

Calmoseptine

Anorectal Ointment

Calmoseptine is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Calmoseptine Inc.. The primary component is Lanolin; Menthol; Petrolatum; Zinc Oxide.

Product ID0799-0001_58f828af-7e71-4d87-b0d3-6e4174fb6293
NDC0799-0001
Product TypeHuman Otc Drug
Proprietary NameCalmoseptine
Generic NameAnorectal Ointment
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date1950-08-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameCalmoseptine Inc.
Substance NameLANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE
Active Ingredient Strength16 g/100g; g/100g; g/100g; g/100g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0799-0001-02

71 g in 1 TUBE (0799-0001-02)
Marketing Start Date1999-01-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0799-0001-04 [00799000104]

Calmoseptine OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date1988-08-01

NDC 0799-0001-06 [00799000106]

Calmoseptine OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-03

NDC 0799-0001-02 [00799000102]

Calmoseptine OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date1999-01-04

NDC 0799-0001-03 [00799000103]

Calmoseptine OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date1950-08-01

NDC 0799-0001-05 [00799000105]

Calmoseptine OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2001-06-01

Drug Details

Active Ingredients

IngredientStrength
LANOLIN15.7 g/100g

OpenFDA Data

SPL SET ID:ff9539ed-d9ae-401d-adbc-df8f1d751431
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1946476
  • 1946481
  • UPC Code
  • 0746876000460

  • Trademark Results [Calmoseptine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CALMOSEPTINE
    CALMOSEPTINE
    73754242 1632114 Dead/Cancelled
    PERRY LABORATORIES INC.
    1988-09-26

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