YMLABS

Product NDC
10827-0004
11-digit product format
108270004
Labeler code
10827
Product ID
10827-0004_48364bfe-f96d-5040-e063-6294a90a3503
Type
HUMAN OTC DRUG
Nonproprietary name
SPF15 FLAVORED LIP BALM
Dosage form
STICK
Route
TOPICAL
Labeler
Yusef Manufacturing Laboratories
Application
part352
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-30
Substance
OCTINOXATE; OXYBENZONE
Active strength
.294; .168 g/4.2g; g/4.2g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
YMLABS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE.294 g/4.2g
OXYBENZONE.168 g/4.2g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 95OOS7VE0Y

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10827-0004-12024-04-18C16284748780-11030e364-ff14-111a-e063-dadaa90a10e2YMlabs SPF15 Flavored Lip Balm
10827-0004-12024-01-30C16284748780-11030e364-ff14-111a-e063-dadaa90a10e2YMlabs SPF15 Flavored Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10827-0004-1YMLABS4.2 g in 1 TUBESTICK4.24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10827-0004YMLABS (SPF15 FLAVORED LIP BALM) STICK [YUSEF MANUFACTURING LABORATORIES]3Current NDC, Legacy NDC, 1 package rows20240428_6c456df1-db54-481b-b583-186b9bdaf670.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10827-0004-1108270004014.2 g in 1 TUBE (10827-0004-1) 4.2 g2021-12-300000-00-00NoNoCurrent