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 2 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ActivICEMENTHOLMedline Industries, LP834adeb9-38ad-0cfe-e053-2991aa0af82f2026-09-01WarningsExact identifier
application number: M017
La Vaquita New ExtraMETHYL SALICYLATE, MENTHOLDelon Laboratories (1990) Ltd3097a01b-cee5-492f-b65a-63992fb28e3a2026-09-01WarningsExact identifier
application number: M017
Terramed Just Think Comfort Hydrocortisone 1% CreamHYDROCORTISONERida LLC0d2c0c2c-370f-4adb-b0ea-1e218c927f8b2026-09-01WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEHyVee Inc53157137-b980-45d2-aa10-8c111c0ec2f42026-08-31WarningsExact identifier
application number: M017
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsExact identifier
application number: M017
EAYONYUM BACK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a458280-4f9c-5af6-e063-6394a90acb2e2026-08-30WarningsExact identifier
application number: M017
EAYONYUM KNEE PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a45d19f-c753-71eb-e063-6294a90a48052026-08-30WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive SkinHYDROCORTISONEAmerisourceBergenc5c5b5ca-b4d4-4fa8-b647-b3ccb29664952026-08-30WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHORHAWAII REPACK, INC.31ed3d82-ba12-46b2-b0ec-7e5e019efc102026-08-28WarningsExact identifier
application number: M017
4% Lidocaine Patches4% LIDOCAINE PATCHESShenzhen Chaoxiji Technology Co.,Ltd.5a177987-7c05-f07f-e063-6394a90aa9ba2026-08-28WarningsExact identifier
application number: M017
Relieved Pro Wrap4% LIDOCAINE PATCHTransfer Technology5a1c6ebf-ad3f-c47b-e063-6294a90aa19a2026-08-28WarningsExact identifier
application number: M017
Sinsinpas Arex Pain Relieving Patch, MediumCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.46453ef2-512b-4852-e063-6394a90a89122026-08-28WarningsExact identifier
application number: M017
Sinsinpas arex patch largeCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.47c242da-56cd-bea1-e063-6394a90a41de2026-08-28WarningsExact identifier
application number: M017
4% Lidocaine Patches4% LIDOCAINE PATCHESShenzhen Chaoxiji Technology Co.,Ltd.5a16c6aa-3ab0-3e46-e063-6294a90a6d8f2026-08-27WarningsExact identifier
application number: M017
Lidocaine Patch 4%LIDOCAINE 4%Global America Group LLC1eec782d-0e56-43d2-b842-da0ae47c5dc92026-08-26WarningsExact identifier
application number: M017
Careland Lidocaine Plus Menthol Pain RelievingLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd0f928b5b-60f5-4a45-a409-c601eb3304872026-08-26WarningsExact identifier
application number: M017
PARCHE CALIENTECAPSAICINA AND MENTOLDW SUPPORT LLC59f2708e-295a-ccb3-e063-6394a90ad3952026-08-26WarningsExact identifier
application number: M017
CVS Pain ReliefLIDOCAINECVS Pharmacy4ecbc263-e0d4-18d5-e063-6294a90a72e92026-08-26WarningsExact identifier
application number: M017
CVS Pain Relief Lidocaine XLLIDOCAINECVS Pharmacy4aa286e3-e274-8095-e063-6394a90ae8712026-08-26WarningsExact identifier
application number: M017
TERAPIA DE DIA Y NOCHEPAIN RELIEVING PATCHDW SUPPORT LLC59f44135-865b-9d7d-e063-6294a90a9dd92026-08-26WarningsExact 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