FDA.reportPublic FDA data

Blistex

Product NDC
10157-9951
11-digit product format
101579951
Labeler code
10157
Product ID
10157-9951_36a0ff8e-6ede-4902-a8ec-a71496008247
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone, Camphor (synthetic), Menthol, and Phenol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Blistex Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-12-01
Substance
DIMETHICONE; CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PHENOL
Active strength
1.1; .5; .625; .5 g/100g; 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
Brand name suffix
Medicated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE1.1 g/100g
CAMPHOR (SYNTHETIC).5 g/100g
MENTHOL, UNSPECIFIED FORM.625 g/100g
PHENOL.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
339NCG44TVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2107300Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e95439d3-f12b-4c1c-999a-79f2ddba4cfbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-9951-1Blistex Medicated6 g in 1 TUBEOINTMENT64
10157-9951-2Blistex Medicated1 in 1 CARTONOINTMENT14
10157-9951-3Blistex Medicated10 g in 1 TUBEOINTMENT104
10157-9951-4Blistex Medicated2.25 g in 1 TUBEOINTMENT2.254
10157-9951-5Blistex Medicated8 g in 1 TUBEOINTMENT84
10157-9951-6Blistex Medicated6 g in 1 TUBEOINTMENT64
10157-9951-7Blistex Medicated3 in 1 CARTONOINTMENT34
10157-9951-7Blistex Medicated6 g in 1 TUBEOINTMENT64
10157-9951-8Blistex Medicated4 in 1 CARTONOINTMENT44
10157-9951-8Blistex Medicated6 g in 1 TUBEOINTMENT64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10157-9951-2GM - Gram10157-995195deb1e4-cebc-4c0f-abdf-bea69a3668c112014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Camphor (synthetic)ACTIVE INGREDIENT5TJD82A1ETBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
DimethiconeACTIVE INGREDIENT92RU3N3Y1OBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
MentholACTIVE INGREDIENTL7T10EIP3ABLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
PhenolACTIVE INGREDIENT339NCG44TVBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
Camphor (synthetic)ACTIVE MOIETY5TJD82A1ETBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
DimethiconeACTIVE MOIETY92RU3N3Y1OBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
MentholACTIVE MOIETYL7T10EIP3ABLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
PhenolACTIVE MOIETY339NCG44TVBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
allantoinINACTIVE INGREDIENT344S277G0ZBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
ammoniaINACTIVE INGREDIENT5138Q19F1XBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
calcium hydroxideINACTIVE INGREDIENTPF5DZW74VNBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
edetate calcium disodium anhydrousINACTIVE INGREDIENT8U5D034955BLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
hydrated silicaINACTIVE INGREDIENTY6O7T4G8P9BLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
lanolinINACTIVE INGREDIENT7EV65EAW6HBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
lauric acidINACTIVE INGREDIENT1160N9NU9UBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
myristic acidINACTIVE INGREDIENT0I3V7S25AWBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
oleic acidINACTIVE INGREDIENT2UMI9U37CPBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
palmitic acidINACTIVE INGREDIENT2V16EO95H1BLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZEBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
polyglyceryl-3 diisostearateINACTIVE INGREDIENT46P231IQV8BLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
waterINACTIVE INGREDIENT059QF0KO0RBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1
yellow waxINACTIVE INGREDIENT2ZA36H0S2VBLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-9951BLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]4Current NDC, Legacy NDC, 10 package rows20241213_e95439d3-f12b-4c1c-999a-79f2ddba4cfb.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 9 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4dfc77bb-11dd-e0f0-e063-6294a90a4e9c2026-07-24WarningsExact identifier
application number: M017
DRAVYNOR QUIT SMOKING PatchesNICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5768631f-d517-5b43-e063-6294a90a8f462026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a5b47ce-2bf1-42c7-e063-6294a90af09f2026-07-23WarningsExact identifier
application number: M017
DERMFREE WART CORN REMOVERSALICYLIC ACID 40% WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5c63b3-44de-8736-e063-6394a90ac21a2026-07-23WarningsExact identifier
application number: M017
DERMFREE Anti-itchHYDROCORTISONE1% ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a5af4c6-555a-e74c-e063-6394a90aa6ce2026-07-23WarningsExact identifier
application number: M017
DERMFREE HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4a5d0e79-d620-0147-e063-6294a90a31032026-07-23WarningsExact identifier
application number: M017
MAG 5 PT WARMING FORMULAMENTHOLRENU LABORATORIES, LLCa499ac9b-0e8e-e23f-e053-2a95a90abe9a2026-07-23WarningsExact identifier
application number: M017
Icy Hot Performance Cream Pain ReliefMENTHOL 16%, CAMPHOR 11%Chattem, Inc.73f7a113-ef11-4932-bf4d-4e62863f79412026-07-23WarningsExact identifier
application number: M017
Numbing Pain ReliefLIDOCAINE 4%Walgreen Company2425badb-e196-e9f8-e063-6294a90a7bf42026-07-22WarningsExact identifier
application number: M017
Cooling Pain ReliefMENTHOL 4.5%Walgreen Company24345ccf-c96f-31b0-e063-6294a90a82b52026-07-22WarningsExact identifier
application number: M017
Heat Pain ReliefCAPSAICIN 0.1%Walgreen Company2434f9cf-74aa-17af-e063-6294a90a56d92026-07-22WarningsExact identifier
application number: M017
Pain Relief Patch LidocaineLIDOCAINEHyVee41c26a66-3371-2c2c-e063-6294a90aa38b2026-07-22WarningsExact identifier
application number: M017
CVS Ultra Strength MuscleMENTHOL, CAMPHOR, METHYL SALICYLATECVS Pharmacy48bef8bc-6e39-a328-e063-6394a90ae4502026-07-22WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCdaad9a1e-98d2-4ce7-9d97-ac5d81905abb2026-07-22WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative573c2d85-9e0b-7955-e063-6394a90aff642026-07-22WarningsExact identifier
application number: M017
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
application number: M017
Bclsks NUMBINGMENTHOL 1% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e26770-ddf6-7515-e063-6394a90a4ab32026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE21MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5e9691-727f-6bcd-e063-6294a90aadfc2026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE14MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5eec19-7f9a-d277-e063-6294a90ace952026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE7MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5f124e-2dd7-16b8-e063-6294a90a5cdb2026-07-21WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2107300camphor 0.5 % / dimethicone 1.1 % / menthol 0.625 % / phenol 0.5 % Topical OintmentPSNe95439d3-f12b-4c1c-999a-79f2ddba4cfb4
2107300camphor 0.005 MG/MG / dimethicone 0.011 MG/MG / menthol 0.00625 MG/MG / phenol 0.005 MG/MG Topical OintmentSCDe95439d3-f12b-4c1c-999a-79f2ddba4cfb4
2107300camphor 0.5 % / dimethicone 1.1 % / menthol 0.625 % / phenol 0.5 % Topical OintmentSYe95439d3-f12b-4c1c-999a-79f2ddba4cfb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10157-9951-1101579951016 g in 1 TUBE (10157-9951-1) 6 g2000-12-010000-00-00NoNoCurrent
10157-9951-2101579951021 TUBE in 1 CARTON (10157-9951-2) / 6 g in 1 TUBE (10157-9951-6) 1 tube2000-12-010000-00-00NoNoCurrent
10157-9951-31015799510310 g in 1 TUBE (10157-9951-3) 10 g2000-12-010000-00-00NoNoCurrent
10157-9951-4101579951042.25 g in 1 TUBE (10157-9951-4) 2.25 g2000-12-010000-00-00NoNoCurrent
10157-9951-5101579951058 g in 1 TUBE (10157-9951-5) 8 g2000-12-010000-00-00NoNoCurrent
10157-9951-6101579951066 g in 1 TUBE6 gHistorical
10157-9951-7101579951073 TUBE in 1 CARTON (10157-9951-7) / 6 g in 1 TUBE3 tube2000-12-010000-00-00NoNoCurrent
10157-9951-8101579951084 TUBE in 1 CARTON (10157-9951-8) / 6 g in 1 TUBE4 tube2000-12-010000-00-00NoNoCurrent