FDA.reportPublic FDA data

BAG BALM Skin Protectant

Product NDC
69845-031
Requested package NDC
69845-031-02
11-digit product format
698450031
Labeler code
69845
Product ID
69845-031_8ac1414d-55c0-4c4a-88e9-07161adcfbc9
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
VERMONT`S ORIGINAL, LLC
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-03-01
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
84 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage69845-03169845-031-02IInactivated 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, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69845-031-022026-01-29C16284748780-149896155-bb48-586f-e063-e6dba90add90Drug Facts
69845-031-042026-01-29C16284748780-149896155-bb48-586f-e063-e6dba90add90Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69845-031-02BAG BALM Skin Protectant57 g in 1 TUBEOINTMENT573
69845-031-04BAG BALM Skin Protectant113 g in 1 CANOINTMENT1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69845-031BAG BALM SKIN PROTECTANT (PETROLATUM) OINTMENT [VERMONT`S ORIGINAL, LLC]3Legacy NDC, 2 package rows20190307_a823d9cc-6d37-4276-aa50-8c98bdd5c837.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2000540petrolatum 84.3 % Topical OintmentPSNa823d9cc-6d37-4276-aa50-8c98bdd5c8373
2000540petrolatum 0.843 MG/MG Topical OintmentSCDa823d9cc-6d37-4276-aa50-8c98bdd5c8373
2000540petrolatum 84.3 % Topical OintmentSYa823d9cc-6d37-4276-aa50-8c98bdd5c8373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69845-031-026984500310257 g in 1 TUBE (69845-031-02) 57 g2018-03-010000-00-00NoNoCurrent