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 |
|---|---|---|---|---|---|---|
| Hemorrhoid Pain Relief | LIDOCAINE | Telebrands Corp | 04164425-ca3b-ef24-e063-6294a90a59d8 | 2024-11-20 | Warnings | M015 |
| Hempvana Maximum Strength Pain Relief Topical Anesthetic | LIDOCAINE | Telebrands Corp | f525075a-d7ee-dad0-e053-2a95a90a6f3f | 2024-11-20 | Warnings | M015 |
| Curist Lidocaine Numbing Relief | LIDOCAINE | Little Pharma, Inc. | bff3c422-a0df-6196-e053-2a95a90af033 | 2024-11-20 | Warnings | M015 |
| Hempvana Maximum Strength Pain Relief Topical Anesthetic Platinum | LIDOCAINE 5% | Telebrands Corp | 2774ec41-7366-ac8c-e063-6394a90a1ee2 | 2024-11-20 | Warnings | M015 |
| Walgreens Anorectal Lidocaine Cream | 5% LIDOCAINE | Walgreens Company | 3052fac7-fd68-43f4-9950-8c07288a6b6d | 2024-11-20 | Warnings | M015 |
| Lidocaine Anorectal | LIDOCAINE | Patrin Pharma, Inc | 456d41fe-8449-4980-9291-d7a3b65a900d | 2024-11-13 | Warnings | M015 |
| MyDerm | PENYLEPHRINE HCI, WITCH HAZEL, LIDOCAINE HCL, | Inspec Solution LLC. | 2618eba1-9308-a666-e063-6394a90ac3d2 | 2024-11-04 | Warnings | M015 |
| Granulotion Medicated | MENTHOL, ZINC OXIDE | GL HEALTH, INC. | 01701780-b160-415b-b34d-362237179475 | 2024-10-29 | Warnings | M015 |
| rexall hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Dolgencorp Inc | 0415c51b-5a12-49d4-8968-0131ddb85545 | 2024-10-23 | Warnings | M015 |
| Exchange Select Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Army & Air Force Exchange Service | 8155ed74-9412-498f-998c-4a29c46e934f | 2024-10-23 | Warnings | M015 |
| Leader Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. dba Leader | c4814524-0f4c-4351-a431-5b4b6431fd28 | 2024-10-23 | Warnings | M015 |
| basic care hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Amazon.com Services LLC | 617d9213-31f0-4c71-be0c-7961b96e5143 | 2024-10-23 | Warnings | M015 |
| Signature Care Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Safeway | e74b71a1-915d-4e5b-b548-d5cce7945dbd | 2024-10-23 | Warnings | M015 |
| Equaline Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | d29b7824-ff9e-4875-b3de-92721c8add0e | 2024-10-23 | Warnings | M015 |
| hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Publix Super Markets Inc | a241cb37-7007-4fd8-a12e-f3fc6d6f780e | 2024-10-22 | Warnings | M015 |
| hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Kroger Company | d44ca22a-dc20-454d-99aa-403a8c7a3e00 | 2024-10-22 | Warnings | M015 |
| rugby hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Rugby Laboratories | c1a126b5-0d34-437f-a7ef-8d5cbeb7b03b | 2024-10-22 | Warnings | M015 |
| hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Meijer Distribution Inc | 1431397e-3515-4794-a494-70667948e14c | 2024-10-18 | Warnings | M015 |
| signature care hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Safeway | afcf68cf-f187-44d3-ad91-b1e79b182bc6 | 2024-10-17 | Warnings | M015 |
| hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | H E B | 1435432d-5ff2-468b-808d-fb0c99a0717b | 2024-10-17 | 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 |