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 ID | 0799-0001_58f828af-7e71-4d87-b0d3-6e4174fb6293 |
| NDC | 0799-0001 |
| Product Type | Human Otc Drug |
| Proprietary Name | Calmoseptine |
| Generic Name | Anorectal Ointment |
| Dosage Form | Ointment |
| Route of Administration | TOPICAL |
| Marketing Start Date | 1950-08-01 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Labeler Name | Calmoseptine Inc. |
| Substance Name | LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE |
| Active Ingredient Strength | 16 g/100g; g/100g; g/100g; g/100g |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0799-0001-02
71 g in 1 TUBE (0799-0001-02)
| Marketing Start Date | 1999-01-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0799-0001-04 [00799000104]
Calmoseptine OINTMENT
| Marketing Category | OTC monograph final |
| Application Number | part346 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | GM |
| Marketing Start Date | 1988-08-01 |
NDC 0799-0001-06 [00799000106]
Calmoseptine OINTMENT
| Marketing Category | OTC monograph final |
| Application Number | part346 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-07-03 |
NDC 0799-0001-02 [00799000102]
Calmoseptine OINTMENT
| Marketing Category | OTC monograph final |
| Application Number | part346 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | GM |
| Marketing Start Date | 1999-01-04 |
NDC 0799-0001-03 [00799000103]
Calmoseptine OINTMENT
| Marketing Category | OTC monograph final |
| Application Number | part346 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | GM |
| Marketing Start Date | 1950-08-01 |
NDC 0799-0001-05 [00799000105]
Calmoseptine OINTMENT
| Marketing Category | OTC monograph final |
| Application Number | part346 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2001-06-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| LANOLIN | 15.7 g/100g |
OpenFDA Data
| SPL SET ID: | ff9539ed-d9ae-401d-adbc-df8f1d751431 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Trademark Results [Calmoseptine]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CALMOSEPTINE 73754242 1632114 Dead/Cancelled |
PERRY LABORATORIES INC. 1988-09-26 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.