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 15 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine and MentholLIDOCAINE AND MENTHOLAdvanced Rx of Tennessee, LLC44840250-2112-6ef4-e063-6394a90acdcc2026-06-12WarningsExact identifier
application number: M017
DRAWYUM Pain Relief Gel-PatchLIDOCAINE 4% PAIN RELIEF GEL-PATCHJiangxi Yudexi Pharmaceutical Co., LTD497e6e18-ba46-0001-e063-6294a90af0262026-06-12WarningsExact identifier
application number: M017
NATUHEAL JOINT BACK PAIN RELIEFARNICA MONTANA HPUS 7% JOINT BACK PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4c923afa-4d1e-0776-e063-6294a90a2f542026-06-12WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Aldermed Inc.4a7b532e-b292-b595-e063-6394a90acc9c2026-06-12WarningsExact identifier
application number: M017
MG PLUS MENTHOLMENTHOLRENU LABORATORIES, LLC53737365-b985-3800-e063-6294a90a37f22026-06-11WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc7c78d980-fc94-498c-aec5-464c0c76c8f42026-06-11WarningsExact identifier
application number: M017
ANIXIKE NumbingLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a47f1ed-d8cf-3b0b-e063-6394a90a932a2026-06-11WarningsExact identifier
application number: M017
Anti-Itch Soothing Wipes 1 Pramoxine HydrochloridePRAMOXINE HYDROCHLORIDEThe Honey Pot Company LLC81ab7fa7-d9b0-49dc-9782-02f37e588c5e2026-06-10WarningsExact identifier
application number: M017
HealthWise Pain Relief Cream with LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcareef176d33-10b9-ddb2-e053-2995a90a76e32026-06-10WarningsExact identifier
application number: M017
Warm Patch Tong Gu Huo Luo GaoPAIN PATCHSheng Chang Pharmaceutical Co, Ltd. Zhongli Factory6906c4a0-1557-45e3-b915-80e4dd652ee72026-06-10WarningsExact identifier
application number: M017
LidoMedixLIDOCAINE, MENTHOL, CAMPHORAbsolute Therapeutics, LLC53d504ef-eea3-6a47-e063-6394a90a1f652026-06-09WarningsExact identifier
application number: M017
good sense anti itchHYDROCORTISONEPreferred Pharmaceuticals Inc.e51047da-8e17-4dd7-be3c-54820a7485f22026-06-09WarningsExact identifier
application number: M017
Terramed Just Think Comfort GynoCare BV Guard Intimate WashPRAMOXINE HYDROCHLORIDERida LLC09964550-049c-4c3b-817d-37e660c2e45c2026-06-08WarningsExact identifier
application number: M017
Quality Choice Lidocaine Pain Relief PatchLIDOCAINEQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)526abe69-4bbc-6e73-e063-6394a90ad25d2026-06-08WarningsExact identifier
application number: M017
Dcsily Numbing CreamLIDOCAINEShenzhen Xinxin Yunhai Technology Co., Ltd.53cab09c-6d5d-471e-e063-6294a90aa9772026-06-08WarningsExact identifier
application number: M017
Easment 0.1% Capsaicin cream for sensitive skinCAPSAICIN 0.1%Easment LLC537e0106-9e1c-66b8-e063-6294a90ac5382026-06-05WarningsExact identifier
application number: M017
Maximum Strength Pain ReliefMENTHOL CREAMOWELL NATURALS LLC5388f2c5-8cfd-a601-e063-6294a90a2e5f2026-06-04WarningsExact identifier
application number: M017
MG PLUS ROLL ONMENTHOL ROLL ONRENU LABORATORIES, LLC535dc42f-38c7-2afc-e063-6294a90ae23d2026-06-03WarningsExact identifier
application number: M017
OP First Aid Series Insect Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.b43af183-834a-0f64-e053-2995a90a32182026-06-03WarningsExact identifier
application number: M017
PURE PRIMAL DELAYLIDOCAINE HCLProdigy Media Inc1ddab664-7c44-452f-854f-e386cd69505e2026-06-03WarningsExact 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