FDA.reportPublic FDA data

Lip Medex Lip Balm

Product NDC
10157-1194
11-digit product format
101571194
Labeler code
10157
Product ID
10157-1194_310b31e0-2782-4a70-a62e-1f2e06b3e36a
Type
HUMAN OTC DRUG
Nonproprietary name
PETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, and PHENOL
Dosage form
STICK
Route
TOPICAL
Labeler
Blistex Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-01
Substance
PETROLATUM; CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PHENOL
Active strength
42; 1; 1; .6 g/100g; g/100g; g/100g; 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
Lip Medex Lip Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM42 g/100g
CAMPHOR (SYNTHETIC)1 g/100g
MENTHOL, UNSPECIFIED FORM1 g/100g
PHENOL.6 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
339NCG44TVInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
988f97e8-a59f-4bc0-9d71-60607364a686Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-1194-1Lip Medex Lip Balm4.25 g in 1 CYLINDERSTICK4.251
10157-1194-3Lip Medex Lip Balm4.25 g in 1 CYLINDERSTICK4.251
10157-1194-3Lip Medex Lip Balm3 in 1 CARTONSTICK31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-1194LIP MEDEX LIP BALM (PETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL) STICK [BLISTEX INC.]1Current NDC, 3 package rows20240703_988f97e8-a59f-4bc0-9d71-60607364a686.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 44 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TetracaineTETRACAINEBellus Medical, LLC60cabb5f-606b-7a74-e053-2a91aa0ac0242026-01-09WarningsExact identifier
application number: M017
BenzocaineBENZOCAINEBellus Medical, LLC60cafbaf-8ec6-46a5-e053-2a91aa0af11f2026-01-09WarningsExact identifier
application number: M017
PRAXPRAMOXINE HYDROCHLORIDEAvPAKdc646399-91ba-5cc1-e053-2a95a90a4f9c2026-01-09WarningsExact identifier
application number: M017
2.5% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLCc842544a-6aea-42af-a77e-7b202371b3872026-01-09WarningsExact identifier
application number: M017
4% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLC7fb95135-4151-4ef4-bb6d-75251cafff6c2026-01-09WarningsExact identifier
application number: M017
Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEMeijer Distribution, Inc781f89c0-94ab-48de-9e0b-decb37bcde462026-01-09WarningsExact identifier
application number: M017
LIDOCAINE PAIN RELIEVING Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd2159fb73-cf6c-184a-e063-6394a90a1d142026-01-08WarningsExact identifier
application number: M017
PAIN RELIEF Gel-PatchLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd22d9ce20-1cb6-c5bd-e063-6394a90a9eca2026-01-08WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INT'L THERMO ANALGETICS ROLL-ON76ef713b-e23d-7b98-e053-2991aa0aad512026-01-08WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INCbbf0ca84-2800-d222-e053-2995a90ad8f32026-01-08WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAvPAKef5b0db6-8f0a-4f8e-e053-2995a90a22b72026-01-08WarningsExact identifier
application number: M017
Capsaicin Topical AnalgesicCAPSAICINAvPAKef597423-cd01-7324-e053-2a95a90aa1ba2026-01-08WarningsExact identifier
application number: M017
Capsaicin External AnalgesicCAPSAICINAvPAKef5a3846-1d2f-7023-e053-2a95a90ad7162026-01-08WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAvPAKef5bb0fa-afc2-62d7-e053-2a95a90a37f42026-01-08WarningsExact identifier
application number: M017
K2 Cold TherapyMENTHOLThe Podiatree Co60dce1ad-125e-396d-e053-2a91aa0a670f2026-01-08WarningsExact identifier
application number: M017
Burn Relief AloeLIDOCAINE HCLAcutens48c435fe-2670-4b80-bf01-923dc93544222026-01-08WarningsExact identifier
application number: M017
Relieve A PainLIDOCAINERelieve A Pain LLCcafaa830-d894-4590-8928-d579cc791d792026-01-08WarningsExact identifier
application number: M017
DZUL ARTHRITIS PAIN RELIEFMENTHOLCaball Sales, Inc.159c301c-d462-bb2c-e063-6394a90a9e5a2026-01-08WarningsExact identifier
application number: M017
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
application number: M017
TOPICAINELIDOCAINE 4%ESBA LABORATORIES INC.7f96e980-891e-743d-e053-2a91aa0aea5f2026-01-08WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10157-1194-1101571194014.25 g in 1 CYLINDER (10157-1194-1) 4.25 g2024-07-01NoNoCurrent
10157-1194-3101571194033 CYLINDER in 1 CARTON (10157-1194-3) / 4.25 g in 1 CYLINDER3 cylinder2024-07-01NoNoCurrent