FDA.reportPublic FDA data

Blistex

Product NDC
10157-9302
11-digit product format
101579302
Labeler code
10157
Product ID
10157-9302_78fbbd4f-548d-4b5a-8e15-2ae2a01a3592
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine and Chloroxylenol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Blistex Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-05
Substance
BENZOCAINE; CHLOROXYLENOL
Active strength
5; .1 g/100g; g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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
Brand name suffix
Foille Medicated First Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE5 g/100g
CHLOROXYLENOL.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
0F32U78V2QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199005Internal RxNorm lookup
213034Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e2eca808-e97b-43e0-aa51-7025cc61c7a8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-9302-3Blistex Foille Medicated First Aid1 in 1 CARTONOINTMENT14
10157-9302-3Blistex Foille Medicated First Aid14 g in 1 TUBEOINTMENT144
10157-9302-4Blistex Foille Medicated First Aid1 in 1 CARTONOINTMENT14
10157-9302-4Blistex Foille Medicated First Aid28 g in 1 TUBEOINTMENT284

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5BLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
ChloroxylenolACTIVE INGREDIENT0F32U78V2QBLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
BenzocaineACTIVE MOIETYU3RSY48JW5BLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
ChloroxylenolACTIVE MOIETY0F32U78V2QBLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHBLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
calcium hydroxideINACTIVE INGREDIENTPF5DZW74VNBLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
ceresinINACTIVE INGREDIENTQ1LS2UJO3ABLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
corn oilINACTIVE INGREDIENT8470G57WFMBLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
edetate calcium disodium anhydrousINACTIVE INGREDIENT8U5D034955BLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
eugenolINACTIVE INGREDIENT3T8H1794QWBLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
maleic anhydrideINACTIVE INGREDIENTV5877ZJZ25BLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
polyethylene glycol 1500INACTIVE INGREDIENT1212Z7S33ABLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
sodium borateINACTIVE INGREDIENT91MBZ8H3QOBLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JBLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
waterINACTIVE INGREDIENT059QF0KO0RBLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1
yellow waxINACTIVE INGREDIENT2ZA36H0S2VBLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-9302BLISTEX FOILLE MEDICATED FIRST AID (BENZOCAINE AND CHLOROXYLENOL) OINTMENT [BLISTEX INC.]4Current NDC, Legacy NDC, 4 package rows20241213_e2eca808-e97b-43e0-aa51-7025cc61c7a8.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 67 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QIAN LI ZHUI FENG PAIN RELIEVINGCAMPHOR, MENTHOL, AND METHYL SALICYLATEMADISON ONE ACME INC03a4fb7c-2328-409d-99c8-cbcf2b4a451f2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
WU YANG BRAND PAIN RELIEVING MEDICATEDMENTHOL AND CAMPHORMADISON ONE ACME INC05c6b95a-aeb6-4234-97c7-8d77eccb38d82025-11-10WarningsExact identifier
application number: M017
HEI GUI PAIN RELIEVINGCAMPHOR AND METHYL SALICYLATEMADISON ONE ACME INC4140c404-edab-4923-941d-f74125e943a92025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
E MEI SHAN MEDICATEDCAMPHOR AND MENTHOLMADISON ONE ACME INCddcc814e-fcc4-4232-9ab4-826b8aac35f02025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
OvertimeMETHYL SALICYLATE, MENTHOL AND CAPSAICINPhysicians Science & Nature Inc.25fec070-8587-42d1-ba6f-1a9c150acc982025-11-10WarningsExact identifier
application number: M017
Dendracin NeurodendraxcinMETHYL SALICYLATE, MENTHOL AND CAPSAICINPhysicians Science & Nature Inc.05742cd5-ece2-4007-bdf0-46b76d23df742025-11-10WarningsExact identifier
application number: M017
Anal BluDESENSITIZERNovelties by Nasswalk, Inc.03b9555b-c3ff-4baa-e063-6394a90afb2c2025-11-10WarningsExact identifier
application number: M017
StallionDELAY CREMENovelties by Nasswalk, Inc.0261ec88-8fe4-d5f8-e063-6294a90ab3d42025-11-10WarningsExact identifier
application number: M017
ANAL-ESEDESENSITIZERNovelties by Nasswalk, Inc.03b89eed-b433-a263-e063-6294a90a675b2025-11-10WarningsExact identifier
application number: M017
Instant ErectionULTIMATE ERECTION ENHANCERNovelties by Nasswalk, Inc.03a444f9-7052-0c38-e063-6294a90a4e562025-11-10WarningsExact identifier
application number: M017
STA-HARDDESENSITIZING LUBRICANTNovelties by Nasswalk, Inc.02ef794b-8e70-5c26-e063-6294a90a28d12025-11-10WarningsExact identifier
application number: M017
ANAL-ESEDESENSITIZERNovelties by Nasswalk, Inc.03a4a7ce-4cff-a608-e063-6294a90ad65d2025-11-10WarningsExact identifier
application number: M017
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION04de4392-74f6-7df8-e063-6294a90ae3b12025-11-08WarningsExact identifier
application number: M017
Johnson and Johnson All Purpose First Aid KitACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC5cdb47c5-7951-4279-8a05-0a3199d3dd452025-11-06WarningsExact identifier
application number: M017
Johnson and Johnson First Aid Travel Ready 80 CTACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf388f105-48ba-4616-e053-2a95a90a00492025-11-06WarningsExact identifier
application number: M017
Johnson and Johnson First Aid All Purpose 160 CTACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf3933330-2550-4a88-e053-2a95a90a39972025-11-06WarningsExact identifier
application number: M017
Foot and Leg Pain ReliefLIDOCAINEPremier Brands of America Inc.42f23e2f-11c6-da49-e063-6294a90ac7202025-11-06WarningsExact identifier
application number: M017
HEALING TREE CALMING ANTI-ITCHHYDROCORTISONERenu Laboratories, LLCfc8bcde9-26e8-a35f-e053-6394a90a33002025-11-06WarningsExact identifier
application number: M017
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
application number: M017
Extra Strength Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATEChain Drug Marketing Association Inc1a2997bc-7741-e658-e063-6394a90af6fd2025-11-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199005benzocaine 5 % / chloroxylenol 0.1 % Topical OintmentPSNe2eca808-e97b-43e0-aa51-7025cc61c7a84
213034Foille 5 % / 0.1 % Topical OintmentPSNe2eca808-e97b-43e0-aa51-7025cc61c7a84
213034benzocaine 0.05 MG/MG / chloroxylenol 0.001 MG/MG Topical Ointment [Foille]SBDe2eca808-e97b-43e0-aa51-7025cc61c7a84
199005benzocaine 0.05 MG/MG / chloroxylenol 0.001 MG/MG Topical OintmentSCDe2eca808-e97b-43e0-aa51-7025cc61c7a84
199005benzocaine 5 % / chloroxylenol 0.1 % Topical OintmentSYe2eca808-e97b-43e0-aa51-7025cc61c7a84
213034Foille (benzocaine 5 % / chloroxylenol 0.1 % ) Topical OintmentSYe2eca808-e97b-43e0-aa51-7025cc61c7a84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10157-9302-3101579302031 TUBE in 1 CARTON (10157-9302-3) / 14 g in 1 TUBE1 tube2016-09-230000-00-00NoNoCurrent
10157-9302-4101579302041 TUBE in 1 CARTON (10157-9302-4) / 28 g in 1 TUBE1 tube2013-03-050000-00-00NoNoCurrent