FDA.reportPublic FDA data

Mentholatum Medicated Lip Balm

Product NDC
10742-8865
Requested package NDC
10742-8865-3
11-digit product format
107428865
Labeler code
10742
Product ID
10742-8865_2979ebf9-e75f-6f98-e063-6394a90a49f4
Type
HUMAN OTC DRUG
Nonproprietary name
dimethicone, octinoxate, octisalate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
The Mentholatum Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-01
Substance
DIMETHICONE; OCTINOXATE; OCTISALATE
Active strength
10; 75; 50 mg/g; mg/g; mg/g
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mentholatum Medicated Lip Balm
Brand name suffix
Original
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE10 mg/g
OCTINOXATE75 mg/g
OCTISALATE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df1Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
10742-8865-12023-02-07Drug Facts - Mentholatum Medicated Lip Balm
10742-8865-32023-02-07Drug Facts - Mentholatum Medicated Lip Balm
10742-8865-12023-01-30Drug Facts - Mentholatum Medicated Lip Balm
10742-8865-32023-01-30Drug Facts - Mentholatum Medicated Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8865-1Mentholatum Medicated Lip BalmOriginal4.2 g in 1 TUBEOINTMENT4.24
10742-8865-1Mentholatum Medicated Lip BalmOriginal1 in 1 BLISTER PACKOINTMENT14
10742-8865-3Mentholatum Medicated Lip BalmOriginal3 in 1 BLISTER PACKOINTMENT34
10742-8865-3Mentholatum Medicated Lip BalmOriginal4.2 g in 1 TUBEOINTMENT4.24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8865MENTHOLATUM MEDICATED LIP BALM ORIGINAL (DIMETHICONE, OCTINOXATE, OCTISALATE) OINTMENT [THE MENTHOLATUM COMPANY]4Current NDC, Legacy NDC, 4 package rows20241219_f84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df1.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 361 · 7,202 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENZINC OXIDEISNTREE Inc.58e38665-0bca-fb02-e063-6394a90ad62a2026-08-13WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d3d390-8b88-a6fe-e063-6394a90a9bf82026-08-12WarningsExact identifier
application number: M020
Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d7a3e3-b7df-43ce-e063-6294a90a729c2026-08-12WarningsExact identifier
application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc58dd81db-46d4-d763-e063-6394a90abb0b2026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50 Red CorrectingZINC OXIDECP Skin Health Group, Inc.26e63890-d1af-d171-e063-6394a90af8282026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50ZINC OXIDECP Skin Health Group, Inc.26d2683f-cfd5-50fd-e063-6394a90a75762026-08-12WarningsExact identifier
application number: M020
doTERRA Sun BodyMINERAL SUNSCREENdoTERRA International, LLC58dcc56f-f093-469c-e063-6394a90a60882026-08-12WarningsExact identifier
application number: M020
Colorescience Total Protection Body Shield GlowZINC OXIDEColorescience52e1d987-a4f8-195e-e063-6294a90a56292026-08-11WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
application number: M020
Ciele Tint and ProtectZINC OXIDECiele0162d9c9-07fa-9210-e063-6294a90aa6872026-08-11WarningsExact identifier
application number: M020
NeoStrata Skin Active Matrix Support SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.8e4b9c08-b906-4c5f-a243-55838ae28b902026-08-10WarningsExact identifier
application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-10WarningsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.1c7cd904-ffff-48aa-91bd-cc978946b36a2026-08-10Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.22aa46af-5d0f-4256-8f45-be06f66275612026-08-10WarningsExact identifier
application number: M020
Colorescience Total Protection No Show Mineral Body ShieldZINC OXIDEColorescience52e1f59e-63cb-7480-e063-6394a90ad7c52026-08-10WarningsExact identifier
application number: M020
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
application number: M020
ULTRA VIOLETTE Unblock Screen SPF 50 SunscreenBEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDEGrace and Fire USA Inc.56ad0dce-410e-9d78-e063-6294a90a1c3e2026-08-09WarningsExact identifier
application number: M020
ORLASKIN SPF50 Antioxidant SoothingComplex SunscreenETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEGuangzhou Yapheon Health Industry Co., Ltd.552a36ed-7a66-4048-e063-6394a90a09bc2026-08-08WarningsExact identifier
application number: M020
lip balm SPF15( 2533) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5870aa44-1375-cdc5-e063-6394a90af4a52026-08-07WarningsExact identifier
application number: M020
lip balm SPF15( Zinc oxide) 01ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.5871ab1d-cf07-d737-e063-6394a90a58fe2026-08-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-8865-3107428865033 TUBE in 1 BLISTER PACK (10742-8865-3) / 4.2 g in 1 TUBE3 tube2018-10-010000-00-00NoNoCurrent