FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Calmoseptine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANOLIN15.7 g/100g
MENTHOL.44 g/100g
PETROLATUM24 g/100g
ZINC OXIDE20.6 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7EV65EAW6H, L7T10EIP3A, 4T6H12BN9U, SOI2LOH54Z
Rxcui1946476, 1946481

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0799-0001-02Calmoseptine71 g in 1 TUBEOINTMENT7114
0799-0001-03Calmoseptine71 g in 1 JAROINTMENT7114
0799-0001-04Calmoseptine113 g in 1 TUBEOINTMENT11314
0799-0001-05Calmoseptine3.5 g in 1 PACKETOINTMENT3.514
0799-0001-06Calmoseptine20 g in 1 TUBEOINTMENT2014
0799-0001-04DERMAWERX ZMT PAK113 g in 1 TUBEOINTMENT113 g20.6 g in 100g1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0799-0001-02GM - Gram0799-000195b8e2fc-087a-4e01-83db-ce0dba8b6a8112012-07-24
0799-0001-03GM - Gram0799-00016b232653-4859-4f99-b068-04502e33711f12017-10-13
0799-0001-04GM - Gram0799-0001e98285a3-d153-478e-9313-f028945ee9c312012-07-24
0799-0001-05GM - Gram0799-00010529cae0-8e6d-4662-b39b-f4c593dd85b812014-11-05
0799-0001-06GM - Gram0799-000186923745-4ac0-44a9-8331-e4693c47320612023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ACALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [CALMOSEPTINE INC. ]8
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [CALMOSEPTINE INC. ]8
MENTHOLACTIVE MOIETYL7T10EIP3ACALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [CALMOSEPTINE INC. ]8
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [CALMOSEPTINE INC. ]8
ChlorothymolINACTIVE INGREDIENTLJ25TI0CVTCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [CALMOSEPTINE INC. ]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [CALMOSEPTINE INC. ]8
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [CALMOSEPTINE INC. ]8
LanolinINACTIVE INGREDIENT7EV65EAW6HCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [CALMOSEPTINE INC. ]8
PhenolINACTIVE INGREDIENT339NCG44TVCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [CALMOSEPTINE INC. ]8
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QOCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [CALMOSEPTINE INC. ]8
ThymolINACTIVE INGREDIENT3J50XA376ECALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [CALMOSEPTINE INC. ]8
MENTHOLACTIVE INGREDIENTL7T10EIP3ACALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
MENTHOL, UNSPECIFIED FORMACTIVE INGREDIENTL7T10EIP3ADERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
TRETINOINACTIVE INGREDIENT5688UTC01RDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
LEVOMENTHOLACTIVE MOIETYBZ1R15MTK7CALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
MENTHOL, UNSPECIFIED FORMACTIVE MOIETYL7T10EIP3ADERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
TRETINOINACTIVE MOIETY5688UTC01RDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
CHLOROTHYMOLINACTIVE INGREDIENTLJ25TI0CVTDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
ChlorothymolINACTIVE INGREDIENTLJ25TI0CVTCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
LanolinINACTIVE INGREDIENT7EV65EAW6HCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
LANOLININACTIVE INGREDIENT7EV65EAW6HDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
PHENOLINACTIVE INGREDIENT339NCG44TVDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
PhenolINACTIVE INGREDIENT339NCG44TVCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QOCALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
THYMOLINACTIVE INGREDIENT3J50XA376EDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
ThymolINACTIVE INGREDIENT3J50XA376ECALMOSEPTINE (ZINC OXIDE AND MENTHOL) OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0799-0001CALMOSEPTINE (ANORECTAL OINTMENT) OINTMENT [CALMOSEPTINE INC.]14Current NDC, Legacy NDC, 5 package rows20250116_ff9539ed-d9ae-401d-adbc-df8f1d751431.zip
0799-0001DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1Current NDC, Legacy NDC20151118_24682288-1be4-42af-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1946481Calmoseptine 15.7 % / 0.44 % / 24 % / 20.6 % Topical OintmentPSNff9539ed-d9ae-401d-adbc-df8f1d75143114
1946476lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical OintmentPSNff9539ed-d9ae-401d-adbc-df8f1d75143114
1946481lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calmoseptine]SBDff9539ed-d9ae-401d-adbc-df8f1d75143114
1946476lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCDff9539ed-d9ae-401d-adbc-df8f1d75143114
1946481Calmoseptine Ointment (lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG) Topical OintmentSYff9539ed-d9ae-401d-adbc-df8f1d75143114
1946481Calmoseptine OIntment (lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % ) Topical OintmentSYff9539ed-d9ae-401d-adbc-df8f1d75143114
1946476Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical OintmentSYff9539ed-d9ae-401d-adbc-df8f1d75143114
1946481Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment [Calmoseptine]SYff9539ed-d9ae-401d-adbc-df8f1d75143114
1946476lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical OintmentSYff9539ed-d9ae-401d-adbc-df8f1d75143114
1946481Calmoseptine 15.7 % / 0.44 % / 24 % / 20.6 % Topical OintmentPSN9aa48789-dc1c-452e-8125-f0cd0c792d5b1
1946481Calmoseptine 15.7 % / 0.44 % / 24 % / 20.6 % Topical OintmentPSN24682288-1be4-42af-e054-00144ff88e881
1946476lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical OintmentPSN24682288-1be4-42af-e054-00144ff88e881
1946476lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical OintmentPSN9aa48789-dc1c-452e-8125-f0cd0c792d5b1
106302tretinoin 0.025 % Topical CreamPSN24682288-1be4-42af-e054-00144ff88e881
1946481lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calmoseptine]SBD24682288-1be4-42af-e054-00144ff88e881
1946481lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calmoseptine]SBD9aa48789-dc1c-452e-8125-f0cd0c792d5b1
1946476lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCD9aa48789-dc1c-452e-8125-f0cd0c792d5b1
1946476lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCD24682288-1be4-42af-e054-00144ff88e881
106302tretinoin 0.25 MG/ML Topical CreamSCD24682288-1be4-42af-e054-00144ff88e881
1946481Calmoseptine Ointment (lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG) Topical OintmentSY9aa48789-dc1c-452e-8125-f0cd0c792d5b1
1946481Calmoseptine Ointment (lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG) Topical OintmentSY24682288-1be4-42af-e054-00144ff88e881
1946481Calmoseptine OIntment (lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % ) Topical OintmentSY9aa48789-dc1c-452e-8125-f0cd0c792d5b1
1946481Calmoseptine OIntment (lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % ) Topical OintmentSY24682288-1be4-42af-e054-00144ff88e881
1946476Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical OintmentSY9aa48789-dc1c-452e-8125-f0cd0c792d5b1
1946476Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical OintmentSY24682288-1be4-42af-e054-00144ff88e881
1946481Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment [Calmoseptine]SY9aa48789-dc1c-452e-8125-f0cd0c792d5b1
1946481Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment [Calmoseptine]SY24682288-1be4-42af-e054-00144ff88e881
1946476lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical OintmentSY9aa48789-dc1c-452e-8125-f0cd0c792d5b1
1946476lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical OintmentSY24682288-1be4-42af-e054-00144ff88e881
106302tretinoin 0.025 % Topical CreamSY24682288-1be4-42af-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0799-0001-020079900010271 g in 1 TUBE (0799-0001-02) 71 g1999-01-040000-00-00NoNoCurrent
0799-0001-030079900010371 g in 1 JAR (0799-0001-03) 71 g1950-08-010000-00-00NoNoCurrent
0799-0001-0400799000104113 g in 1 TUBE (0799-0001-04) 113 g1988-08-010000-00-00NoNoCurrent
0799-0001-05007990001053.5 g in 1 PACKET (0799-0001-05) 3.5 g2001-06-010000-00-00NoNoCurrent
0799-0001-060079900010620 g in 1 TUBE (0799-0001-06) 20 g2017-07-030000-00-00NoNoCurrent