FDA.reportPublic FDA data

Blistex Medicated Lip Balm

Product NDC
10157-1119
11-digit product format
101571119
Labeler code
10157
Product ID
10157-1119_ea073bea-814d-4be1-b7cc-d71288674006
Type
HUMAN OTC DRUG
Nonproprietary name
DIMETHICONE, OCTINOXATE, and OCTISALATE
Dosage form
STICK
Route
TOPICAL
Labeler
Blistex Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-15
Substance
DIMETHICONE; OCTINOXATE; OCTISALATE
Active strength
2; 6.6; 4.4 g/100g; g/100g; g/100g
Pharmacologic classes
Skin Barrier Activity [PE]
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 Medicated Lip Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE2 g/100g
OCTINOXATE6.6 g/100g
OCTISALATE4.4 g/100g

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
8b4160ed-8889-4e3a-947f-a56c3324dbbeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-1119-1Blistex Medicated Lip Balm1 in 1 CARTONSTICK14
10157-1119-1Blistex Medicated Lip Balm4.25 g in 1 CYLINDERSTICK4.254
10157-1119-2Blistex Medicated Lip Balm4.25 g in 1 CYLINDERSTICK4.254
10157-1119-3Blistex Medicated Lip Balm3 in 1 CARTONSTICK34
10157-1119-3Blistex Medicated Lip Balm4.25 g in 1 CYLINDERSTICK4.254
10157-1119-4Blistex Medicated Lip Balm4.25 g in 1 CYLINDERSTICK4.254
10157-1119-4Blistex Medicated Lip Balm4 in 1 CARTONSTICK44
10157-1119-5Blistex Medicated Lip Balm5 in 1 CARTONSTICK54
10157-1119-5Blistex Medicated Lip Balm4.25 g in 1 CYLINDERSTICK4.254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-1119BLISTEX MEDICATED LIP BALM (DIMETHICONE, OCTINOXATE, AND OCTISALATE) STICK [BLISTEX INC]4Current NDC, Legacy NDC, 9 package rows20240214_8b4160ed-8889-4e3a-947f-a56c3324dbbe.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 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10157-1119-1101571119011 CYLINDER in 1 CARTON (10157-1119-1) / 4.25 g in 1 CYLINDER1 cylinder2018-01-150000-00-00NoNoCurrent
10157-1119-2101571119024.25 g in 1 CYLINDER (10157-1119-2) 4.25 g2024-02-08NoNoCurrent
10157-1119-3101571119033 CYLINDER in 1 CARTON (10157-1119-3) / 4.25 g in 1 CYLINDER3 cylinder2018-01-150000-00-00NoNoCurrent
10157-1119-4101571119044 CYLINDER in 1 CARTON (10157-1119-4) / 4.25 g in 1 CYLINDER4 cylinder2018-01-150000-00-00NoNoCurrent
10157-1119-5101571119055 CYLINDER in 1 CARTON (10157-1119-5) / 4.25 g in 1 CYLINDER5 cylinder2020-12-160000-00-00NoNoCurrent