FDA.reportPublic FDA data

Blistex Lip Medex

Product NDC
10157-8407
11-digit product format
101578407
Labeler code
10157
Product ID
10157-8407_c9b9b923-9098-499f-bfa3-509400bb9f82
Type
HUMAN OTC DRUG
Nonproprietary name
PETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), and PHENOL
Dosage form
PASTE
Route
TOPICAL
Labeler
Blistex Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-03-28
Substance
PETROLATUM; MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC); PHENOL
Active strength
59.14; 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
Blistex Lip Medex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM59.14 g/100g
MENTHOL, UNSPECIFIED FORM1 g/100g
CAMPHOR (SYNTHETIC)1 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
L7T10EIP3AInternal UNII lookup
5TJD82A1ETInternal 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
8ad39005-9419-4f1a-a1ae-2f76d212455eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-8407-1Blistex Lip Medex7.08 g in 1 JARPASTE7.083
10157-8407-1Blistex Lip Medex1 in 1 BLISTER PACKPASTE13
10157-8407-2Blistex Lip Medex1 in 1 BLISTER PACKPASTE13
10157-8407-2Blistex Lip Medex10.75 g in 1 JARPASTE10.753
10157-8407-3Blistex Lip Medex3 in 1 BLISTER PACKPASTE33
10157-8407-3Blistex Lip Medex7.08 g in 1 JARPASTE7.083
10157-8407-4Blistex Lip Medex7.08 g in 1 JARPASTE7.083
10157-8407-5Blistex Lip Medex10.75 g in 1 JARPASTE10.753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-8407BLISTEX LIP MEDEX (PETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOL) PASTE [BLISTEX INC.]3Current NDC, Legacy NDC, 8 package rows20240127_8ad39005-9419-4f1a-a1ae-2f76d212455e.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 4 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH Lidocaine Plus MentholLIDOCAINE, MENTHOLARMY AND AIR FORCE EXCHANGE SERVICE60f72061-d264-424e-b396-5a609076d3522026-08-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF5980c527-6bcb-a846-e063-6294a90a07882026-08-20WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergen5fb5e5ce-b268-4444-8b63-ea7ea6abf2692026-08-20WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsExact identifier
application number: M017
Eagle Brand Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0822bcde-a8ad-be95-e063-6294a90ad2082026-08-19WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONEHyVee Inc1ab6bbb8-2b91-4c53-9168-b1e85ac296e92026-08-19WarningsExact identifier
application number: M017
hydrocortisone 1HYDROCORTISONEKroger Companyf05edff2-2dc5-427c-b52c-518e0aaef4e02026-08-19WarningsExact identifier
application number: M017
MedPrideHYDROCORTISONEShield Line LLC2f15d3b3-d1e6-4742-9eac-f956c0ffbba42026-08-18WarningsExact identifier
application number: M017
Pain Relieving Cream AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEGarcoa, Inc.2f736307-5cd4-4a76-9044-4aeecba096cc2026-08-18WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll onPAIN RELIEF ROLL ONNeilMed Pharmaceuticals Inc58ff9d2d-99e6-8f98-e063-6394a90a8de72026-08-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1/2%Sun Pharmaceutical Industries, Inc.59337940-c9be-58af-e063-6394a90abe132026-08-16WarningsExact identifier
application number: M017
SIERQ NumbingMENTHOLPutian Licheng District Zhijiancheng Trading Co., Ltd.5936c070-d8e4-56e8-e063-6294a90a56002026-08-16WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5911d9b0-1acb-3546-e063-6294a90adb3a2026-08-15WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology59072f05-eefa-d823-e063-6394a90a0e1a2026-08-14WarningsExact identifier
application number: M017
JJ Care First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCINantong Health & Beyond Hygienic Products Inc.c41621fb-c549-4394-a4cb-cb81ef8c98df2026-08-13WarningsExact identifier
application number: M017
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
application number: M017
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC5384e80f-c242-76a1-e063-6294a90aba0b2026-08-12WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10157-8407-1101578407011 JAR in 1 BLISTER PACK (10157-8407-1) / 7.08 g in 1 JAR1 jar2017-03-280000-00-00NoNoCurrent
10157-8407-2101578407021 JAR in 1 BLISTER PACK (10157-8407-2) / 10.75 g in 1 JAR1 jar2017-03-280000-00-00NoNoCurrent
10157-8407-3101578407033 JAR in 1 BLISTER PACK (10157-8407-3) / 7.08 g in 1 JAR3 jar2022-11-290000-00-00NoNoCurrent
10157-8407-4101578407047.08 g in 1 JAR (10157-8407-4) 7.08 g2024-01-24NoNoCurrent
10157-8407-51015784070510.75 g in 1 JAR (10157-8407-5) 10.75 g2024-01-24NoNoCurrent