FDA.reportPublic FDA data

Anti-Itch Medicated Maximum Strength

Product NDC
69842-588
Requested package NDC
69842-588-28
11-digit product format
698420588
Labeler code
69842
Product ID
69842-588_15fdd717-e419-42b1-ad9f-46873e96ede4
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine and Resorcinol
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS Health
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-09-30
Marketing end
0000-00-00
Substance
BENZOCAINE; RESORCINOL
Active strength
200 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69842-58869842-588-28IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-588-28Anti-Itch Medicated Maximum Strength1 in 1 CARTONCREAM12
69842-588-28Anti-Itch Medicated Maximum Strength28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-588ANTI-ITCH MEDICATED MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CVS HEALTH]2Legacy NDC, 2 package rows20241114_69aa1822-c96b-46a0-95a6-7a7857331c69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamPSN69aa1822-c96b-46a0-95a6-7a7857331c692
637518benzocaine 200 MG/ML / resorcinol 30 MG/ML Vaginal CreamSCD69aa1822-c96b-46a0-95a6-7a7857331c692
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamSY69aa1822-c96b-46a0-95a6-7a7857331c692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-588-28698420588281 TUBE in 1 CARTON (69842-588-28) > 28 g in 1 TUBE1 tube2021-09-300000-00-00NoNoCurrent