Eleven Perfect Form Tinted Lip Balm

Product NDC
71644-015
11-digit product format
716440015
Labeler code
71644
Product ID
71644-015_f1ffe8b6-cc00-38e2-e053-2995a90abf1d
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Cyberderm Laboratories inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-01-14
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
20 g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71644-015DDiscontinued by firm2026-10-05
excluded packagepackage71644-01571644-015-10DDiscontinued by firm2026-10-05

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
71644-015-102023-11-27C16284748780-10191ceaa-68ff-198a-e063-dbdaa90aec3eEleven Tinted Lip Balm Venus
71644-015-102023-07-28C16284748780-10191ceaa-68ff-198a-e063-dbdaa90aec3eEleven Tinted Lip Balm Venus

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71644-015ELEVEN PERFECT FORM TINTED LIP BALM VENUS (ZINC OXIDE) CREAM [CYBERDERM LABORATORIES INC.]3Legacy NDC20231128_b8e1d688-86a0-c720-e053-2995a90a9af9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71644-015-10716440015101 TUBE in 1 CARTON (71644-015-10) > 10 mL in 1 TUBE1 tube2021-01-140000-00-00NoNoCurrent