FDA.reportPublic FDA data

DermacinRx Therazole Pak

Product NDC
59088-893
11-digit product format
590880893
Labeler code
59088
Product ID
59088-893_29306db8-f628-0ef2-e063-6294a90ac68c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clotrimazole and betamethasone dipropionate, zinc oxide
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2016-08-09
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DermacinRx Therazole Pak
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui308714, 416684

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0472-0379-15DermacinRx Therazole Pak15 g in 1 TUBECREAM15 g10 mg in 1g5
0472-0379-15DermacinRx Therazole Pak1 in 1 CARTONCREAM10 mg in 1g5
59088-563-01DermacinRx Therazole Pak4 g in 1 PACKETPASTE120 g200 mg in 1g5
59088-893-00DermacinRx Therazole Pak1 in 1 CARTONKIT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-893-00GM - Gram59088-8937fc5e147-b81b-4230-b8af-61d5d294f10412016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-893DERMACINRX THERAZOLE PAK (CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, ZINC OXIDE) KIT [PURETEK CORPORATION]5Current NDC, Legacy NDC, 4 package rows20241215_c47f8a9c-9c86-4068-814e-05ab2090d19e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSNc47f8a9c-9c86-4068-814e-05ab2090d19e5
416684zinc oxide 20 % Topical PastePSNc47f8a9c-9c86-4068-814e-05ab2090d19e5
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCDc47f8a9c-9c86-4068-814e-05ab2090d19e5
416684zinc oxide 0.2 MG/MG PasteSCDc47f8a9c-9c86-4068-814e-05ab2090d19e5
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSYc47f8a9c-9c86-4068-814e-05ab2090d19e5
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSYc47f8a9c-9c86-4068-814e-05ab2090d19e5
416684zinc oxide 20 % Topical PasteSYc47f8a9c-9c86-4068-814e-05ab2090d19e5
416684ZNO 0.2 MG/MG PasteSYc47f8a9c-9c86-4068-814e-05ab2090d19e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0379-150047203791515 g in 1 TUBE15 gHistorical
59088-563-01590880563014 g in 1 PACKET4 gHistorical
59088-893-00590880893001 KIT in 1 CARTON (59088-893-00) * 1 TUBE in 1 CARTON (0472-0379-15) / 15 g in 1 TUBE * 4 g in 1 PACKET (59088-563-01) 1 kit2016-08-090000-00-00NoNoCurrent