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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308714Internal RxNorm lookup
416684Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c47f8a9c-9c86-4068-814e-05ab2090d19eAvailable on FDA.report

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

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermacinRx Therazole PakCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, ZINC OXIDEPureTek Corporationc47f8a9c-9c86-4068-814e-05ab2090d19e2024-12-13Warnings, Adverse reactionsExact identifier
ndc (product): 59088-893

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