FDA.reportPublic FDA data

ASTONEA PETROLATUM

Product NDC
77338-211
Requested package NDC
77338-211-03
11-digit product format
773380211
Labeler code
77338
Product ID
77338-211_f215e9e2-af7a-acbd-e053-2995a90abf8f
Type
HUMAN OTC DRUG
Nonproprietary name
PETROLATUM
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-02-05
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
1 g/g
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 packagepackage77338-21177338-211-03IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
77338-211-01ASTONEA PETROLATUM
77338-211-02ASTONEA PETROLATUM
77338-211-03ASTONEA PETROLATUM
77338-211-04ASTONEA PETROLATUM
77338-211-05ASTONEA PETROLATUM
77338-211-06ASTONEA PETROLATUM
77338-211-07ASTONEA PETROLATUM
77338-211-08ASTONEA PETROLATUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-211-01ASTONEA PETROLATUM5 g in 1 PACKETOINTMENT55
77338-211-02ASTONEA PETROLATUM56.6 g in 1 TUBEOINTMENT56.65
77338-211-03ASTONEA PETROLATUM368.5 g in 1 JAROINTMENT368.55
77338-211-04ASTONEA PETROLATUM226 g in 1 JAROINTMENT2265
77338-211-05ASTONEA PETROLATUM368 g in 1 JAROINTMENT3685
77338-211-06ASTONEA PETROLATUM425 g in 1 JAROINTMENT4255
77338-211-07ASTONEA PETROLATUM113 g in 1 TUBEOINTMENT1135
77338-211-08ASTONEA PETROLATUM100 g in 1 JAROINTMENT1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-211ASTONEA PETROLATUM (PETROLATUM) OINTMENT [ASTONEA LABS PRIVATE LIMITED]5Legacy NDC, 8 package rows20240426_e68adb93-047f-b5b6-e053-2995a90a59b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSNe68adb93-047f-b5b6-e053-2995a90a59b95
204754petrolatum 1 MG/MG Topical OintmentSCDe68adb93-047f-b5b6-e053-2995a90a59b95
204754petrolatum 100 % Topical JellySYe68adb93-047f-b5b6-e053-2995a90a59b95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-211-0377338021103368.5 g in 1 JAR (77338-211-03) 368.5 g2013-02-050000-00-00NoNoCurrent