FDA.reportPublic FDA data

DERMAWERX ZMT PAK

Product NDC
69329-600
11-digit product format
693290600
Labeler code
69329
Product ID
69329-600_2468bf3e-e346-1d73-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, and TRETINOIN
Dosage form
KIT
Labeler
Patchwerx Labs, Inc.
Application
ANDA075264
Marketing category
ANDA
Marketing start
2015-09-08
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69329-600-302020-01-31C16284748780-19d75b9cf-fb72-f424-e053-dadaa90a57ce24682288-1be4-42af-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0799-0001-04DERMAWERX ZMT PAK113 g in 1 TUBEOINTMENT113 g20.6 g in 100g1
69329-600-30DERMAWERX ZMT PAK1 in 1 CARTONKIT11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
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
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
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, 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 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
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
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
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
69329-600DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1Legacy NDC, 2 package rows20151118_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 OintmentPSN24682288-1be4-42af-e054-00144ff88e881
1946476lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical OintmentPSN24682288-1be4-42af-e054-00144ff88e881
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
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 OintmentSY24682288-1be4-42af-e054-00144ff88e881
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 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]SY24682288-1be4-42af-e054-00144ff88e881
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 formatDescriptionUnitsStatus
0799-0001-0400799000104113 g in 1 TUBE113 gHistorical
69329-600-30693290600301 in 1 CARTONHistorical