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 |
|---|---|---|---|---|---|---|
| PREPARATION H MEDICATED WIPES | WITCH HAZEL | Haleon US Holdings LLC | 8d9961f0-1ecf-d7fb-b6b4-856d636d68e1 | 2026-03-17 | Warnings | M015 |
| Crane Safety Burn | LIDOCAINE | Crane Safety LLC | 96d81566-6321-731e-e053-2995a90ad07d | 2026-03-16 | Warnings | M015 |
| Signature Lidocaine Pain Relief Cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 4c56b3b3-33b3-a50e-e063-6394a90a955f | 2026-03-06 | Warnings | M015 |
| WowDay Medicated Hemorrhoidal Flushable Wipes | MEDICATED HEMORRHOIDAL FLUSHABLE WIPES | WowDay LLC | 4c603b27-4835-bc40-e063-6394a90a8ea2 | 2026-03-06 | Warnings | M015 |
| Numb Fast Hemorrhoidal | LIDOCAINE | Oasis Plus LLC | a00ffed7-8034-4cc0-87c4-3c793c1bcd6e | 2026-03-03 | Warnings | M015 |
| Curist Lidocaine Relief | LIDOCAINE 5% | Little Pharma, Inc. | f562b57d-6592-93fa-e053-2995a90ae3e0 | 2026-03-02 | Warnings | M015 |
| Therapain Plus | MENTHOL ROLL-ON | Epic Laboratories, LLC | 0249cfdf-b7c4-f27d-e063-6294a90aaa26 | 2026-03-02 | Warnings | M015 |
| Liposomal Hemorrhoid Master | LIDOCAINE , PHENYLEPHRINE HCL | Clinical Resolution Laboratory, Inc. | a1e15d2a-44b6-4d9c-89c2-0ff12285724e | 2026-03-02 | Warnings | M015 |
| Equate Hemorrhoid Relief | LIDOCAINE | Walmart Inc. | 48646860-ed5d-62a0-e063-6394a90abb23 | 2026-03-01 | Warnings | M015 |
| Witch Hazel | WITCH HAZEL | The Kroger Co. | bbf2efd7-f181-403b-ac5f-695f7ba15875 | 2026-02-27 | Warnings, Adverse reactions | M015 |
| Dermatool Hemorrhoidal | GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL | Papalo Group LLC | 4bc06f41-7733-ebd0-e063-6294a90af7a8 | 2026-02-26 | Warnings | M015 |
| Megababe Fun Gal Stuff Antifungal | CLOTRIMAZOLE | Megababe LLC | c599d27b-fdb0-465f-9e43-13d32c520a92 | 2026-02-25 | Warnings | M015 |
| Witch Hazel | WITCH HAZEL | Better Living Brands, LLC | 0355edab-b6f7-4e59-bce1-cf6a8897b989 | 2026-02-24 | Warnings, Adverse reactions | M015 |
| Zinc Oxide and Menthol | ZINC OXIDE, MENTHOL | Akron Formulations India Private Limited | 4b84556c-521f-eebd-e063-6394a90a8e1e | 2026-02-23 | Warnings | M015 |
| Calprotect | MENTHOL, ZINC OXIDE | Reliable 1 Laboratories LLC | 09fb2810-0cc1-b2e2-e063-6294a90a4576 | 2026-02-19 | Warnings | M015 |
| Oxify | LIDOCAINE 5% | Weeks & Leo Compnay, INC. | 41d9d0b4-33e7-7e05-e063-6394a90a1011 | 2026-02-17 | Warnings | M015 |
| WowDay Hemorrhoid and Fissure Cream | HEMORRHOID AND FISSURE CREAM | WowDay LLC | 47ba86ad-240a-e733-e063-6394a90a24e3 | 2026-02-12 | Warnings | M015 |
| Gniby - LIDOCAINE ANORECTAL HEMORRHOIDAL | NUMBING | Putian Licheng District Zhijiancheng Trading Co., Ltd. | 4a5f59f1-c11a-e2eb-e063-6394a90a3e27 | 2026-02-10 | Warnings | M015 |
| Numb Master | LIDOCAINE | Clinical Resolution Laboratory, Inc. | 0921c824-a8a9-4707-a480-c750192983f5 | 2026-02-09 | Warnings | M015 |
| Signature Care Hemorrhoidal | MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCI | Better Living Brands, LLC | 3c8b43f3-6e1e-499e-ba71-ffdf836f6743 | 2026-02-05 | 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 |