FDA.reportPublic FDA data

Brandless Lip Balm Coconut Broad Spectrum

Product NDC
54111-139
Requested package NDC
54111-139-50
11-digit product format
541110139
Labeler code
54111
Product ID
54111-139_d2c64b2b-2fbd-44ee-afa7-0a782605a85e
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Bentley Laboratories, LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-05-01
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
1 g/4.25g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage54111-13954111-139-50DDiscontinued by firm2026-08-11

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 · 5 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54111-139-502022-06-27C16284748780-19d75b9d0-9946-f424-e053-dadaa90a57ceBrandless Lip Balm Coconut Broad Spectrum SPF 15
54111-139-502020-01-31C16284748780-19d75b9d0-9946-f424-e053-dadaa90a57ceBrandless Lip Balm Coconut Broad Spectrum SPF 15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-139BRANDLESS LIP BALM COCONUT BROAD SPECTRUM 15% (ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]4Legacy NDC20231220_14ac6086-4e2a-400b-aab7-1ffa6115cf6d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54111-139-50541110139504.25 g in 1 TUBE (54111-139-50) 4.25 g2018-05-010000-00-00NoNoCurrent