Calmoseptine
- Product NDC
- 0799-0001
- 11-digit product format
- 007990001
- Labeler code
- 0799
- Product ID
- 0799-0001_2ba19ed3-445d-e95a-e063-6394a90abb3f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- anorectal ointment
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Calmoseptine Inc.
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1950-08-01
- Substance
- LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE
- Active strength
- 15.7; .44; 24; 20.6 g/100g; g/100g; g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Dataset | Scope | Package NDC |
|---|---|---|
| excluded product | product | |
| excluded package | package | 0799-0001-04 |
| excluded package | package | 0799-0001-02 |
| excluded package | package | 0799-0001-03 |
| excluded package | package | 0799-0001-05 |
| excluded package | package | 0799-0001-06 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Calmoseptine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LANOLIN | 15.7 g/100g |
| MENTHOL | .44 g/100g |
| PETROLATUM | 24 g/100g |
| ZINC OXIDE | 20.6 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7EV65EAW6H | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
| 4T6H12BN9U | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ff9539ed-d9ae-401d-adbc-df8f1d751431 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0799-0001-02 | Calmoseptine | 71 g in 1 TUBE | OINTMENT | 71 | 14 | |
| 0799-0001-03 | Calmoseptine | 71 g in 1 JAR | OINTMENT | 71 | 14 | |
| 0799-0001-04 | Calmoseptine | 113 g in 1 TUBE | OINTMENT | 113 | 14 | |
| 0799-0001-05 | Calmoseptine | 3.5 g in 1 PACKET | OINTMENT | 3.5 | 14 | |
| 0799-0001-06 | Calmoseptine | 20 g in 1 TUBE | OINTMENT | 20 | 14 | |
| 0799-0001-04 | DERMAWERX ZMT PAK | 113 g in 1 TUBE | OINTMENT | 113 g | 20.6 g in 100g | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0799-0001-02 | GM - Gram | 0799-0001 | 95b8e2fc-087a-4e01-83db-ce0dba8b6a81 | 1 | 2012-07-24 |
| 0799-0001-03 | GM - Gram | 0799-0001 | 6b232653-4859-4f99-b068-04502e33711f | 1 | 2017-10-13 |
| 0799-0001-04 | GM - Gram | 0799-0001 | e98285a3-d153-478e-9313-f028945ee9c3 | 1 | 2012-07-24 |
| 0799-0001-05 | GM - Gram | 0799-0001 | 0529cae0-8e6d-4662-b39b-f4c593dd85b8 | 1 | 2014-11-05 |
| 0799-0001-06 | GM - Gram | 0799-0001 | 86923745-4ac0-44a9-8331-e4693c473206 | 1 | 2023-06-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0799-0001 | CALMOSEPTINE (ANORECTAL OINTMENT) OINTMENT [CALMOSEPTINE INC.] | 14 | Current NDC, Legacy NDC, 5 package rows | 20250116_ff9539ed-d9ae-401d-adbc-df8f1d751431.zip |
| 0799-0001 | DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.] | 1 | Current NDC, Legacy NDC | 20151118_24682288-1be4-42af-e054-00144ff88e88.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pranicura 5 | GLYCERIN, KAOLIN, CALAMINE, MENTHOL | Pranicura Products LLC | af520a58-3f3c-4d28-a41f-3ed8f74da095 | 2025-11-04 | Warnings | M015 |
| ProCure ClamaPlex | ZINC OXIDE 20.625, MENTHOL 0.44, WHITE PETROLATUM 66.335 | Twin Med LLC | 3d366857-5178-9032-e063-6294a90a40f3 | 2025-11-01 | Warnings | M015 |
| GNP Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCL | Amerisource Bergen | b0f0ef97-9add-717f-e053-2a95a90a0eb0 | 2025-10-30 | Warnings | M015 |
| REMEDY Calazime Skin Protectant | CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 1295cfcc-5b61-481b-964b-f53ffd0cb58e | 2025-10-30 | Warnings | M015 |
| Hemorrhoid Anesthetic | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Universal Distribution Center LLC | 186c2d32-e8c5-d13d-e063-6294a90a2b0e | 2025-10-30 | Warnings | M015 |
| Workvie | LIDOCAINE HCL, MENTHOL | Marketites LLC | aebaffb5-58dd-ebd5-e053-2a95a90a14ed | 2025-10-29 | Warnings | M015 |
| hemorrhoidal | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | Publix Super Markets Inc | 354a640c-bc7e-45c8-9df0-8b5b01767f5c | 2025-10-29 | Warnings | M015 |
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Pharmacy Value Alliance LLC | 903b77fc-02bf-73b6-e053-2a95a90ad4cc | 2025-10-24 | Warnings | M015 |
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | CVS Pharmacy | 845fc11b-707d-2027-e053-2991aa0a1c8a | 2025-10-24 | Warnings | M015 |
| Calmol 4 | ZINC OXIDE AND COCOA BUTTER | Resical Inc. | 5516f800-d3fa-4b90-a3eb-c0bdf3183b9b | 2025-10-24 | Warnings | M015 |
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Amerisourcebergen Drug Corporation | 231a850a-bad6-9a30-e063-6394a90a0fdc | 2025-10-24 | Warnings | M015 |
| Signature Care Hemorrhoidal Cream (with applicator) | PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUM | BETTER LIVING BRANDS, LLC | b026a386-5e38-52ed-e053-2a95a90a6b0e | 2025-10-24 | Warnings | M015 |
| Americaine | BENZOCAINE | Insight Pharmaceuticals LLC | d13c022f-2f91-40b4-bd66-0cfc0e147a5f | 2025-10-23 | Warnings | M015 |
| Winco Hemorrhoidal | MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE | Winco Foods, LLC | 04ca3ef1-fc6b-4683-b236-a75afc031fb5 | 2025-10-23 | Warnings | M015 |
| Signature Care Medicated Cooling | WITCH HAZEL | Better Living Brands, LLC | b35dc719-a5a2-4839-870d-25313d3f7c9b | 2025-10-22 | Warnings | M015 |
| Family Care Hemorrhoidal | MINERAL OIL | United Exchange Corp | 04375257-f4f3-48c3-a338-de43298b95eb | 2025-10-22 | Warnings | M015 |
| Family Wellness Hemorrhoidal | MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCL | Family Dollar Services, Inc | fe3293bc-80b5-b60a-e053-6394a90a4ede | 2025-10-22 | Warnings | M015 |
| Xesso Rear Comfort Glide | LIDOCAINE | PREMIUM NATURAL COSMETICS INC | e9eb262e-a1c1-7d5c-e053-2a95a90a7c9f | 2025-10-22 | Warnings | M015 |
| Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Cream | LIDOCAINE | Guangzhou Haishi Biological Technology Co., Ltd. | 41a6d309-2722-1738-e063-6294a90a8a70 | 2025-10-21 | Warnings | M015 |
| DERMOSCRIBE ICHYBUM | HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE | DERMOSCRIBE PTY LTD | 134a88a1-13e5-4da0-8270-c380b57aaeb7 | 2025-10-17 | Warnings | M015 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1946481 | Calmoseptine 15.7 % / 0.44 % / 24 % / 20.6 % Topical Ointment | PSN | ff9539ed-d9ae-401d-adbc-df8f1d751431 | 14 |
| 1946476 | lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical Ointment | PSN | ff9539ed-d9ae-401d-adbc-df8f1d751431 | 14 |
| 1946481 | lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calmoseptine] | SBD | ff9539ed-d9ae-401d-adbc-df8f1d751431 | 14 |
| 1946476 | lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment | SCD | ff9539ed-d9ae-401d-adbc-df8f1d751431 | 14 |
| 1946481 | Calmoseptine Ointment (lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG) Topical Ointment | SY | ff9539ed-d9ae-401d-adbc-df8f1d751431 | 14 |
| 1946481 | Calmoseptine OIntment (lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % ) Topical Ointment | SY | ff9539ed-d9ae-401d-adbc-df8f1d751431 | 14 |
| 1946476 | Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment | SY | ff9539ed-d9ae-401d-adbc-df8f1d751431 | 14 |
| 1946481 | Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment [Calmoseptine] | SY | ff9539ed-d9ae-401d-adbc-df8f1d751431 | 14 |
| 1946476 | lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical Ointment | SY | ff9539ed-d9ae-401d-adbc-df8f1d751431 | 14 |
| 1946481 | Calmoseptine 15.7 % / 0.44 % / 24 % / 20.6 % Topical Ointment | PSN | 9aa48789-dc1c-452e-8125-f0cd0c792d5b | 1 |
| 1946481 | Calmoseptine 15.7 % / 0.44 % / 24 % / 20.6 % Topical Ointment | PSN | 24682288-1be4-42af-e054-00144ff88e88 | 1 |
| 1946476 | lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical Ointment | PSN | 24682288-1be4-42af-e054-00144ff88e88 | 1 |
| 1946476 | lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical Ointment | PSN | 9aa48789-dc1c-452e-8125-f0cd0c792d5b | 1 |
| 106302 | tretinoin 0.025 % Topical Cream | PSN | 24682288-1be4-42af-e054-00144ff88e88 | 1 |
| 1946481 | lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calmoseptine] | SBD | 24682288-1be4-42af-e054-00144ff88e88 | 1 |
| 1946481 | lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calmoseptine] | SBD | 9aa48789-dc1c-452e-8125-f0cd0c792d5b | 1 |
| 1946476 | lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment | SCD | 9aa48789-dc1c-452e-8125-f0cd0c792d5b | 1 |
| 1946476 | lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment | SCD | 24682288-1be4-42af-e054-00144ff88e88 | 1 |
| 106302 | tretinoin 0.25 MG/ML Topical Cream | SCD | 24682288-1be4-42af-e054-00144ff88e88 | 1 |
| 1946481 | Calmoseptine Ointment (lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG) Topical Ointment | SY | 9aa48789-dc1c-452e-8125-f0cd0c792d5b | 1 |
| 1946481 | Calmoseptine Ointment (lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG) Topical Ointment | SY | 24682288-1be4-42af-e054-00144ff88e88 | 1 |
| 1946481 | Calmoseptine OIntment (lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % ) Topical Ointment | SY | 9aa48789-dc1c-452e-8125-f0cd0c792d5b | 1 |
| 1946481 | Calmoseptine OIntment (lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % ) Topical Ointment | SY | 24682288-1be4-42af-e054-00144ff88e88 | 1 |
| 1946476 | Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment | SY | 9aa48789-dc1c-452e-8125-f0cd0c792d5b | 1 |
| 1946476 | Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment | SY | 24682288-1be4-42af-e054-00144ff88e88 | 1 |
| 1946481 | Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment [Calmoseptine] | SY | 9aa48789-dc1c-452e-8125-f0cd0c792d5b | 1 |
| 1946481 | Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment [Calmoseptine] | SY | 24682288-1be4-42af-e054-00144ff88e88 | 1 |
| 1946476 | lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical Ointment | SY | 9aa48789-dc1c-452e-8125-f0cd0c792d5b | 1 |
| 1946476 | lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical Ointment | SY | 24682288-1be4-42af-e054-00144ff88e88 | 1 |
| 106302 | tretinoin 0.025 % Topical Cream | SY | 24682288-1be4-42af-e054-00144ff88e88 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0799-0001-02 | 00799000102 | 71 g in 1 TUBE (0799-0001-02) | 71 g | 1999-01-04 | 0000-00-00 | No | No | Current |
| 0799-0001-03 | 00799000103 | 71 g in 1 JAR (0799-0001-03) | 71 g | 1950-08-01 | 0000-00-00 | No | No | Current |
| 0799-0001-04 | 00799000104 | 113 g in 1 TUBE (0799-0001-04) | 113 g | 1988-08-01 | 0000-00-00 | No | No | Current |
| 0799-0001-05 | 00799000105 | 3.5 g in 1 PACKET (0799-0001-05) | 3.5 g | 2001-06-01 | 0000-00-00 | No | No | Current |
| 0799-0001-06 | 00799000106 | 20 g in 1 TUBE (0799-0001-06) | 20 g | 2017-07-03 | 0000-00-00 | No | No | Current |