FDA.reportPublic FDA data

Curefini Dermal

Product NDC
69981-729
Requested package NDC
69981-729-03
11-digit product format
699810729
Labeler code
69981
Product ID
69981-729_af7f3a02-777e-618d-e053-2a95a90a87e4
Type
HUMAN OTC DRUG
Nonproprietary name
PETROLATUM
Dosage form
CREAM
Route
TOPICAL
Labeler
Rev Pharma Corp.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-02-08
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
300 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage69981-72969981-729-03DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69981-729-01Curefini Dermal177.441 mL in 1 BOTTLE, PLASTICCREAM177.4416
69981-729-01Curefini Dermal1 in 1 BOXCREAM16
69981-729-03Curefini Dermal90 mL in 1 TUBECREAM906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69981-729CUREFINI DERMAL (PETROLATUM) CREAM [REV PHARMA CORP.]6Legacy NDC, 3 package rows20231111_804b354f-47e0-498a-8086-a16a1b29a3a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043075petrolatum 30 % Topical CreamPSN804b354f-47e0-498a-8086-a16a1b29a3a06
1043075petrolatum 300 MG/ML Topical CreamSCD804b354f-47e0-498a-8086-a16a1b29a3a06
1043075petrolatum 30 % Topical CreamSY804b354f-47e0-498a-8086-a16a1b29a3a06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69981-729-036998107290390 mL in 1 TUBE (69981-729-03) 90 ml2018-11-010000-00-00NoNoCurrent