FDA.reportPublic FDA data

Pharmacys Prescription Petroleum Jelly

Product NDC
72197-045
Requested package NDC
72197-045-06
11-digit product format
721970045
Labeler code
72197
Product ID
72197-045_c4eb36ca-ff82-629c-e053-2a95a90a51e5
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
GEL
Route
TOPICAL
Labeler
American Consumer Products Corp
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-06-16
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
100 g/100g
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 packagepackage72197-04572197-045-06IInactivated by FDA2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72197-04572197-045-06UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72197-04572197-045-06UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
72197-045-06Pharmacys Prescription Petroleum Jelly170 g in 1 JARGEL1703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72197-045PHARMACYS PRESCRIPTION PETROLEUM JELLY (PETROLATUM) GEL [AMERICAN CONSUMER PRODUCTS CORP]2Legacy NDC, 1 package rows20250125_c4eb36b5-a1ed-5082-e053-2a95a90a4adf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSNc4eb36b5-a1ed-5082-e053-2a95a90a4adf3
204754petrolatum 1 MG/MG Topical OintmentSCDc4eb36b5-a1ed-5082-e053-2a95a90a4adf3
204754petrolatum 100 % Topical JellySYc4eb36b5-a1ed-5082-e053-2a95a90a4adf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72197-045-0672197004506170 g in 1 JAR (72197-045-06) 170 g2021-06-160000-00-00NoNoCurrent