FDA.reportPublic FDA data

CUREFINI Skin Protection Cream

Product NDC
69981-194
Requested package NDC
69981-194-02
11-digit product format
699810194
Labeler code
69981
Product ID
69981-194_c5f870f7-c9a3-2844-e053-2a95a90a4207
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
2021-07-12
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
300 mg/mL
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 packagepackage69981-19469981-194-02DDiscontinued 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
69981-194-01CUREFINI Skin Protection Cream30 mL in 1 JARCREAM303
69981-194-02CUREFINI Skin Protection Cream60 mL in 1 JARCREAM603
69981-194-04CUREFINI Skin Protection Cream120 mL in 1 JARCREAM1203
69981-194-08CUREFINI Skin Protection Cream240 mL in 1 JARCREAM2403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69981-194CUREFINI SKIN PROTECTION CREAM (PETROLATUM) CREAM [REV PHARMA CORP]2Legacy NDC, 4 package rows20231111_3c594493-5497-434b-9516-8a1f15f7866f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043075petrolatum 30 % Topical CreamPSN3c594493-5497-434b-9516-8a1f15f7866f3
1043075petrolatum 300 MG/ML Topical CreamSCD3c594493-5497-434b-9516-8a1f15f7866f3
1043075petrolatum 30 % Topical CreamSY3c594493-5497-434b-9516-8a1f15f7866f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69981-194-026998101940260 mL in 1 JAR (69981-194-02) 60 ml2021-07-120000-00-00NoNoCurrent