FDA.reportPublic FDA data

Petrolatum Jelly

Product NDC
77338-101
Requested package NDC
77338-101-05
11-digit product format
773380101
Labeler code
77338
Product ID
77338-101_f216106d-2254-fc25-e053-2a95a90aeff8
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-10-11
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
100 g/100g
NDC exclude flag
No
Listing certified through
2024-12-31
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 packagepackage77338-10177338-101-05IInactivated by FDA2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77338-101-032025-01-30C16284748780-12cef2736-a65f-d83d-e063-dadaa90ab31fASTONEA 99.9%
77338-101-052025-01-30C16284748780-12cef2736-a65f-d83d-e063-dadaa90ab31fASTONEA 99.9%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-101-03Petrolatum Jelly226 g in 1 JARJELLY2261
77338-101-05Petrolatum Jelly368 g in 1 JARJELLY3681

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-101PETROLATUM JELLY (PETROLATUM) JELLY [ASTONEA LABS PRIVATE LIMITED]1Legacy NDC, 2 package rows20230113_f2160a9e-efca-dd8b-e053-2a95a90a98da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148414petrolatum 99.9 % Topical GelPSNf2160a9e-efca-dd8b-e053-2a95a90a98da1
1148414petrolatum 0.999 MG/MG Topical GelSCDf2160a9e-efca-dd8b-e053-2a95a90a98da1
1148414petrolatum 99.9 % Topical JellySYf2160a9e-efca-dd8b-e053-2a95a90a98da1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-101-0577338010105368 g in 1 JAR (77338-101-05) 368 g2023-01-010000-00-00NoNoCurrent