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 140 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valtrum IMMEDIATE ACTION TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELABORATORIOS QUANTIUM LLCc4efa317-8dd1-49e1-b7ca-9df2147edd3e2023-12-21WarningsExact identifier
application number: M017
DDM Camphor SpiritCAMPHOR 10%Discount Drug Mart5d56cbe6-4e48-79eb-e053-2a91aa0a74d32023-12-20WarningsExact identifier
application number: M017
Quality Choice Camphor SpiritCAMPHOR 10%Chain Drug Market Association8d352a67-2024-43d0-b525-038d398949e62023-12-20WarningsExact identifier
application number: M017
Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Chain Drug Market Association2cd60df3-bfde-4747-ba4f-7121612f2e632023-12-20WarningsExact identifier
application number: M017
Poison Ivy WashPRAMOXINE HCLChain Drug Market Association873a546b-90ae-50cb-e053-2a91aa0adbfb2023-12-20WarningsExact identifier
application number: M017
Premier Value Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharmacy Value Alliance LLC9d63f8ed-fc50-0d84-e053-2a95a90a6e922023-12-20WarningsExact identifier
application number: M017
Ear DropsCARBAMIDE PEROXIDE 6.5%CVS Pharmacy8a872991-01af-5fd0-e053-2995a90ac7f42023-12-20WarningsExact identifier
application number: M017
CVS Cold and Hot Roll-OnCOOL AND HEAT PAIN RELIEFCVS Pharmacyb8cc578a-be6d-90c0-e053-2995a90a77422023-12-20WarningsExact identifier
application number: M017
Sunmark Camphor SpiritCAMPHOR 10%Strategic Sourcing Services LLC667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa2023-12-19WarningsExact identifier
application number: M017
DDM Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Discount Drug Mart5d56c74f-604d-4fed-e053-2a91aa0a417c2023-12-19WarningsExact identifier
application number: M017
HEB Camphor PhenolCAMPHOR 10.8% AND PHENOL 4.7%H E B5d573883-001d-e5a4-e053-2991aa0a62032023-12-18WarningsExact identifier
application number: M017
Petrocort Antipruritic Lip 21HYDROCORTISONEClinical Formula LLC7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b2023-12-15WarningsExact identifier
application number: M017
DermaWound Wound Care Venous StasisBENZOCAINE HYDROCHLORIDEProgressive Doctors, LLC6221ba86-8b7f-48c8-8284-6950f9fc36b12023-12-15WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%Humco Holding Group, Inc.a8be9e46-1616-40a9-e053-2a95a90ac3bc2023-12-15WarningsExact identifier
application number: M017
Hot/Cold Menthol 16% Roll-OnHOT/COLD MENTHOL 16% ROLL-ONHumco Holding Group, Inca8bf9744-9979-13c1-e053-2a95a90a30aa2023-12-15WarningsExact identifier
application number: M017
Freds Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLDiscount Drug Mart8697b932-da5a-717e-e053-2a91aa0afcae2023-12-12WarningsExact identifier
application number: M017
CVS Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLCVS86972218-31fe-6942-e053-2991aa0a88502023-12-12WarningsExact identifier
application number: M017
Best Choice Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLvalue merchandisers869631f8-aa1e-8ea4-e053-2a91aa0a5c572023-12-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Weeks & Leo Co., Inc.0c5325e3-4796-856c-e063-6394a90a1f902023-12-12WarningsExact identifier
application number: M017
Westlake Anti-itchHYDROCORTISONEWestlake Pharma LLC0c53c982-3f23-a2d5-e063-6394a90acd552023-12-12WarningsExact 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