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 |
|---|---|---|---|---|---|---|
| DCH Rapid Relief Hemorrhoidal | LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25% | Derma Care Research Labs | 00eef84c-a72e-3343-e063-6294a90aa4d8 | 2024-12-19 | Warnings | M015 |
| Formula 2 Skin Care | LIDOCAINE 5% | Derma Care Research Labs | a05d5e07-ae4b-38cc-e053-2a95a90abced | 2024-12-19 | Warnings | M015 |
| Revivol Hemorrhoid and Fissure | GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25% | Derma Care Research Labs, LLC | 0140cf68-b6a0-4378-e063-6394a90afee8 | 2024-12-19 | Warnings | M015 |
| Hemorroidal Cooling gel | PHENYLEPHRINE, WITCH HAZEL | Trifecta Pharmaceuticals Usa Llc | 651c0143-384c-3649-e053-2991aa0a0f28 | 2024-12-18 | Warnings | M015 |
| HemorrhoidalOintment | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI | Trifecta Pharmaceuticals USA LLC | c50cc6ad-e8a0-47c1-e053-2a95a90a4de6 | 2024-12-18 | Warnings | M015 |
| HemorrhoidalOintment | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI | Trifecta Pharmaceuticals USA LLC | fe18fa61-83f9-8bf9-e053-6294a90a7585 | 2024-12-18 | Warnings | M015 |
| HemorrhoidalOintment | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI | Trifecta Pharmaceuticals USA LLC | c59dcb2a-392b-670b-e053-2995a90a9682 | 2024-12-18 | Warnings | M015 |
| TheraCare Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Veridian Healthcare | fab95657-d257-e671-e053-6294a90a59e0 | 2024-12-18 | Warnings | M015 |
| TN Dickinsons Witch Hazel Hemorrhoidal Pads | WITCH HAZEL | Dickinson Brands Inc. | 1b50f4dc-c26a-431a-ae18-c43513871b39 | 2024-12-18 | Warnings | M015 |
| RECTICARE | LIDOCAINE | Ferndale Laboratories, Inc. | 49cb48cf-7a26-4d7a-887f-2e98261d269d | 2024-12-17 | Warnings | M015 |
| Recticare Advanced | LIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUM | Ferndale Laboratories, Inc. | 209212a7-7b6e-4b26-9f31-0eeb76f026bf | 2024-12-17 | Warnings | M015 |
| RECTICARE | LIDOCAINE AND GLYCERIN | Ferndale Laboratories, Inc. | 2b94136a-4975-2925-e054-00144ff88e88 | 2024-12-17 | Warnings | M015 |
| PRAX | PRAMOXINE HYDROCHLORIDE | Ferndale Laboratories, Inc. | 674f0d8b-3d50-42b1-8401-d2967bcdf5cf | 2024-12-17 | Warnings | M015 |
| Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI | Rugby | a5b5e0a9-eee9-2a1e-e053-2a95a90a464e | 2024-12-17 | Warnings | M015 |
| Warrior Rectal Care | LIDOCAINE 4%, PHENYLEPHRINE HYDROCHLORIDE 0.25% | Derma Care Research Labs | fc10cbc3-fc1b-ae09-e053-6394a90ac8f3 | 2024-12-15 | Warnings | M015 |
| Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count) | GLYCERIN, LIDOCAINE, AND WITCH HAZEL | Blistex Inc | a7cb6d78-3048-43b3-afe7-4d862fdcfd3f | 2024-12-13 | Warnings | M015 |
| Tucks Medicated Cooling Pads | WITCH HAZEL | Blistex Inc | b3e68008-3d0d-4124-9579-b503e9fb95c9 | 2024-12-13 | Warnings | M015 |
| T.N. Dickinsons Witch Hazel Medicated Cooling Pads Hemorrhoidal Relief | WITCH HAZEL | Dickinson Brands Inc. | 2a4273a4-3bda-4653-a065-cd4578053f3c | 2024-12-12 | Warnings | M015 |
| Witch Hazel | WITCH HAZEL | Medical Products Laboratories, Inc. | b815792f-2f8f-7ac8-e053-2995a90ade18 | 2024-12-11 | Warnings | M015 |
| Zensa | LIDOCAINE | Alera Skin Care Products Inc. | f56146b6-3c11-4608-a6ab-6142f27e9ac3 | 2024-11-24 | 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 |