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 |
|---|---|---|---|---|---|---|
| HemorrhoidalOintment | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI | Trifecta Pharmaceuticals USA LLC | 4eb3c9ac-268a-5246-e054-00144ff88e88 | 2025-06-09 | Warnings | M015 |
| Bunnies Bum Anorectal Numbing | LIDOCAINE | FloCal Distributors LLC | 3712e151-d171-1c5d-e063-6294a90a36c0 | 2025-06-08 | Warnings | M015 |
| RECOVERY Numbing | LIDOCAINE HCL | Renu Laboratories, LLC | e4e05cae-56a6-b2b3-e053-2a95a90a104b | 2025-06-06 | Warnings | M015 |
| Hemorrohoid Master Cream | LIDOCAINE, PHENYLEPHRINE HCL | Ebanel Laboratories, Inc. | 36eccc74-107e-3914-e063-6294a90a1856 | 2025-06-06 | Warnings | M015 |
| Numb 520 | LIDOCAINE | Ebanel Laboratories, Inc | 36c9988b-9e61-ebbf-e063-6394a90a4114 | 2025-06-04 | Warnings | M015 |
| Hemorrhoid Master | LIDOCAINE, PHENYLEPHRINE HCL | Clinical Resolution Laboratory, Inc. | 36caf20d-116a-f86a-e063-6294a90a7b62 | 2025-06-04 | Warnings | M015 |
| Quick Numb | LIDOCAINE | Clinical Resolution Laboratory, Inc. | 351b95a6-e038-d9aa-e063-6294a90a4172 | 2025-05-29 | Warnings | M015 |
| Dibucaine Topical Anesthetic 1% Hemorrhoidal | DIBUCAINE | Rugby Laboratories Inc. | f23c8cd1-98f9-41cd-84d4-cf01c2ede29a | 2025-05-29 | Warnings | M015 |
| The Femme Fix Hemorrhoid Treatment | LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | POPPY COLLECTIVE LLC | 5217b5d9-b835-4428-a6b3-e6b255630742 | 2025-05-27 | Warnings | M015 |
| MAXOCAINE Topical Anesthetic Anorectal | LIDOCAINE | PRIME COMMERCE, LLC | 26e8c867-8cb8-4a25-91b1-da45a1edd09a | 2025-05-27 | Warnings | M015 |
| Numb25 | LIDOCAINE | Ebanel Laboratories, Inc. | 35107403-55ae-c627-e063-6394a90a0b5c | 2025-05-27 | Warnings | M015 |
| Numb 520 | LIDOCAINE | Ebanel Laboratories, Inc | 350e4d5e-dac7-ae4e-e063-6394a90a76b4 | 2025-05-27 | Warnings | M015 |
| Numb25 | LIDOCAINE 5% | Ebanel Laboratories, Inc | 350fd302-8fd5-5288-e063-6294a90aa382 | 2025-05-27 | Warnings | M015 |
| Numb 520 | LIDOCAINE | Ebanel Laboratories, Inc | 35095bed-0e91-c44a-e063-6294a90add6e | 2025-05-27 | Warnings | M015 |
| Numb520 | LIDOCAINE | Clinical Resolution Laboratory, Inc. | a0411950-c6ee-4427-acb6-3cef58b0e93e | 2025-05-15 | Warnings | M015 |
| Numb25 | LIDOCAINE | Clinical Resolution Laboratory, Inc. | cfcb839d-47b4-4925-bb30-97b64d20d2b3 | 2025-05-15 | Warnings | M015 |
| Numb520 | LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | Clinical Resolution Laboratory, Inc. | 65d3b614-361d-4fb9-9583-a95be754bc82 | 2025-05-15 | Warnings | M015 |
| Chamosyn | BARRIER CREAM | Links Medical Products | f9dfb2d7-4684-4525-994e-1e0ff90413d9 | 2025-05-08 | Warnings | M015 |
| LANOZEM HEMORRHOIDAL | MENTHOL, PETROLATUM | Sod-e Biotech Ltd | 34901e83-8f24-8460-e063-6394a90a2744 | 2025-05-07 | Warnings | M015 |
| PREPARATION H | PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 96d2e0e7-2de0-4660-9ffd-9edb2ad224d8 | 2025-04-18 | 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 |