FDA.reportPublic FDA data

MEDICATED LIP BALM

Product NDC
26052-029
11-digit product format
260520029
Labeler code
26052
Product ID
26052-029_7d8cda7b-4881-6d66-e053-2991aa0ab3ee
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL AND EUCALYPTUS
Dosage form
STICK
Route
TOPICAL
Labeler
Burt's Bees, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-01-04
Substance
MENTHOL
Active strength
.9 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
MEDICATED LIP BALM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.9 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30da3cc5-6140-2dee-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
26052-029-01MEDICATED LIP BALM4.25 g in 1 TUBESTICK4.254
26052-029-02MEDICATED LIP BALM1 in 1 CARTONSTICK14
26052-029-03MEDICATED LIP BALM2 in 1 CARTONSTICK24
26052-029-03MEDICATED LIP BALM4.25 g in 1 TUBESTICK4.254
26052-029-04MEDICATED LIP BALM4.25 g in 1 TUBESTICK4.254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
26052-029MEDICATED LIP BALM (MENTHOL AND EUCALYPTUS) STICK [BURT'S BEES, INC.]4Current NDC, Legacy NDC, 5 package rows20181222_30da3cc5-6140-2dee-e054-00144ff8d46c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDICATED LIP BALMMENTHOL AND EUCALYPTUSBurt's Bees, Inc.30da3cc5-6140-2dee-e054-00144ff8d46c2018-12-21WarningsExact identifier
ndc (product): 26052-029

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
26052-029-01260520029014.25 g in 1 TUBE4.25 gHistorical
26052-029-02260520029021 TUBE in 1 CARTON (26052-029-02) / 4.25 g in 1 TUBE (26052-029-01) 1 tube2016-01-040000-00-00NoNoCurrent
26052-029-03260520029032 TUBE in 1 CARTON (26052-029-03) / 4.25 g in 1 TUBE2 tube2016-01-040000-00-00NoNoCurrent
26052-029-04260520029044.25 g in 1 TUBE (26052-029-04) 4.25 g2016-01-040000-00-00NoNoCurrent