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 27 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPARTANLIDOCAINETIV PRIME SRL4e04146a-ed19-2271-e063-6394a90a50f02026-03-27WarningsExact identifier
application number: M017
Walgreens Pain Relieving LidocaineLIDOCAINEWalgreen Co.41d5bdc4-66c8-31ab-e063-6394a90a11952026-03-27WarningsExact identifier
application number: M017
Walgreens Cool N Heat PatchLIDOCAINE, MENTHOLWalgreen Co.41d64a88-90fc-27ca-e063-6294a90a602b2026-03-27WarningsExact identifier
application number: M017
Softlips Naturals MedicatedCAMPHOR, MENTHOLThe Mentholatum Company4e05d134-6c7f-1501-e063-6294a90ad27d2026-03-27WarningsExact identifier
application number: M017
Walgreens Cool N Heat Patch XLMENTHOLWalgreen Co.41e92435-7f77-a593-e063-6394a90a4b382026-03-27WarningsExact identifier
application number: M017
Walgreens Cool N Heat Back PatchMENTHOLWalgreen Co.41e81110-4b79-1fa6-e063-6394a90ae90c2026-03-27WarningsExact identifier
application number: M017
Softlips Naturals Medicated Elderberry AcaiCAMPHOR, MENTHOLThe Mentholatum Company4e0743a6-d450-043b-e063-6394a90ad1c22026-03-27WarningsExact identifier
application number: M017
QFSN Pain Relief CreamPAIN RELIEF CREAMQiaofusheng Pharmaceuticals Co., Ltd.4d215da1-87f5-d35d-e063-6394a90ac3482026-03-27WarningsExact identifier
application number: M017
FlexSport Roll OnMETHYL SALICYLATEPharmadel LLCbf8de3da-7628-6112-e053-2995a90a8e162026-03-26WarningsExact identifier
application number: M017
Kofal OriginalMETHYL SALICYLATEPharmadel LLC984780fd-496b-150b-e053-2995a90aed772026-03-26WarningsExact identifier
application number: M017
Kofal FuerteMETHYL SALICYLATEPharmadel LLC98488a07-eba0-2b4e-e053-2995a90ad6ab2026-03-26WarningsExact identifier
application number: M017
KofalMETHYL SALICYLATEPharmadel LLC9cac377d-97bc-f0b7-e053-2a95a90a2e122026-03-26WarningsExact identifier
application number: M017
MilagrosoCAMPHORPharmadel LLC12b0401c-84d5-07cd-e063-6394a90a052c2026-03-26WarningsExact identifier
application number: M017
DZUL PAIN FREEZE INSTANT PAIN RELIEFMENTHOLCaball Sales, Inc.4df3abcc-17f3-17f2-e063-6294a90afcca2026-03-26WarningsExact identifier
application number: M017
Equate Cool and Heat Extra StrengthMENTHOLWal-Mart Stores Incca3088a7-e1ec-4e69-80d9-fd0051bde9382026-03-25WarningsExact identifier
application number: M017
Ultra Strength Muscle Rub - CVS Health Ultra Strength Muscle RubCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy2ea95529-ec4b-c2ce-e063-6394a90a07392026-03-25WarningsExact identifier
application number: M017
NUMBING CREAMSMENTHOL LIDOCAINEYongchun Lihui Trading Co., Ltd.4dd38cdf-d644-6da0-e063-6294a90afb3d2026-03-25WarningsExact identifier
application number: M017
ANTIPHLAMINEL-MENTHOL, L-CAMPHOR, METHYL SALICYLATEMasaem Company4dd3ab12-6cd3-1060-e063-6394a90a2dec2026-03-25WarningsExact identifier
application number: M017
LIDOGUARDLIDOCAINE 4%ViolaCare, Inc.d8b021b6-cf71-4f7e-9d27-92d0982bd34f2026-03-25WarningsExact identifier
application number: M017
LactiGoMENTHOLLactiGo, Inc.4dda6ac4-d849-69a6-e063-6394a90a3c542026-03-25WarningsExact 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