FDA.reportPublic FDA data

NEWSDS pak

Product NDC
69329-251
11-digit product format
693290251
Labeler code
69329
Product ID
69329-251_24381bab-d419-035b-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide Cream, Dimethicone Cream
Dosage form
KIT
Labeler
Patchwerx Labs, Inc.
Application
ANDA040671
Marketing category
ANDA
Marketing start
2015-11-10
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69329-251-012020-01-31C16284748780-19d75b9cf-cfc5-f424-e053-dadaa90a57ce24664e10-3424-6186-e054-00144ff88e88
69329-251-022020-01-31C16284748780-19d75b9d0-263e-f424-e053-dadaa90a57ce24749639-0fa6-6a6c-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0603-7862-90NEWSDS pak80 g in 1 TUBECREAM80 g1 mg in 1g2
69329-251-02NEWSDS pak1 in 1 PACKAGEKIT12
69329-253-02NEWSDS pak118 mL in 1 TUBECREAM118 mL50 mg in 1mL2
0603-7862-90NEWSDS pak80 g in 1 TUBECREAM80 g1 mg in 1g1
69329-251-01NEWSDS pak1 in 1 PACKAGEKIT11
69329-253-02NEWSDS pak118 mL in 1 TUBECREAM118 mL50 mg in 1mL1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1ONEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KANEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
DIMETHICONEACTIVE MOIETY92RU3N3Y1ONEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KANEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RANEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3DNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
CARTHAMUS TINCTORIUS SEED OLEOSOMESINACTIVE INGREDIENT9S60Q72309NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMERINACTIVE INGREDIENTRSA9I561OKNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
GINGERINACTIVE INGREDIENTC5529G5JPQNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
KUKUI NUT OILINACTIVE INGREDIENTTP11QR7B8RNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)INACTIVE INGREDIENT255PIF62MSNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1ONEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KANEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1ONEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KANEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RANEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3DNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
CARTHAMUS TINCTORIUS SEED OLEOSOMESINACTIVE INGREDIENT9S60Q72309NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMERINACTIVE INGREDIENTRSA9I561OKNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
GINGERINACTIVE INGREDIENTC5529G5JPQNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
KUKUI NUT OILINACTIVE INGREDIENTTP11QR7B8RNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)INACTIVE INGREDIENT255PIF62MSNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69329-251NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]2Legacy NDC, 3 package rows20151114_24749639-0fa6-6a6c-e054-00144ff88e88.zip
69329-251NEWSDS PAK (TRIAMCINOLONE ACETONIDE CREAM, DIMETHICONE CREAM) KIT [PATCHWERX LABS, INC.]1Legacy NDC, 3 package rows20151113_24664e10-3424-6186-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259090dimethicone 5 % Topical CreamPSN24749639-0fa6-6a6c-e054-00144ff88e882
1014314triamcinolone acetonide 0.1 % Topical CreamPSN24749639-0fa6-6a6c-e054-00144ff88e882
259090dimethicone 50 MG/ML Topical CreamSCD24749639-0fa6-6a6c-e054-00144ff88e882
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD24749639-0fa6-6a6c-e054-00144ff88e882
259090dimethicone 5 % Topical CreamSY24749639-0fa6-6a6c-e054-00144ff88e882
1014314triamcinolone acetonide 0.1 % Topical CreamSY24749639-0fa6-6a6c-e054-00144ff88e882
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY24749639-0fa6-6a6c-e054-00144ff88e882
259090dimethicone 5 % Topical CreamPSN24664e10-3424-6186-e054-00144ff88e881
1014314triamcinolone acetonide 0.1 % Topical CreamPSN24664e10-3424-6186-e054-00144ff88e881
259090dimethicone 50 MG/ML Topical CreamSCD24664e10-3424-6186-e054-00144ff88e881
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD24664e10-3424-6186-e054-00144ff88e881
259090dimethicone 5 % Topical CreamSY24664e10-3424-6186-e054-00144ff88e881
1014314triamcinolone acetonide 0.1 % Topical CreamSY24664e10-3424-6186-e054-00144ff88e881
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY24664e10-3424-6186-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0603-7862-900060378629080 g in 1 TUBE80 gHistorical
69329-251-01693290251011 in 1 PACKAGEHistorical
69329-251-02693290251021 in 1 PACKAGEHistorical
69329-253-0269329025302118 mL in 1 TUBE118 mlHistorical