Eleven Perfect Form Tinted Lip Balm

Product NDC
71644-012
11-digit product format
716440012
Labeler code
71644
Product ID
71644-012_f1ffe4cc-d76d-02c7-e053-2a95a90aa111
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
2020-06-18
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 productproduct71644-012DDiscontinued by firm2026-10-15
excluded packagepackage71644-01271644-012-10DDiscontinued by firm2026-10-15

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
71644-012-102023-11-27C16284748780-10191ceaa-6d1a-198a-e063-dbdaa90aec3eEleven Tinted Lip Balm Game Day
71644-012-102023-07-28C16284748780-10191ceaa-6d1a-198a-e063-dbdaa90aec3eEleven Tinted Lip Balm Game Day

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71644-012ELEVEN PERFECT FORM TINTED LIP BALM GAME DAY (ZINC OXIDE) CREAM [CYBERDERM LABORATORIES INC.]4Legacy NDC20231128_a888c4ba-053e-1843-e053-2a95a90a76fd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71644-012-10716440012101 TUBE in 1 CARTON (71644-012-10) > 10 mL in 1 TUBE1 tube2020-06-190000-00-00NoNoCurrent