Blistex

Product NDC
10157-9539
11-digit product format
101579539
Labeler code
10157
Product ID
10157-9539_374e1e4e-e5c2-4089-a86c-a86ed39d67c9
Type
HUMAN OTC DRUG
Nonproprietary name
Lanolin, Octinoxate, and Oxybenzone
Dosage form
PASTE
Route
TOPICAL
Labeler
Blistex Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-07-01
Marketing end
0000-00-00
Substance
LANOLIN; OCTINOXATE; OXYBENZONE
Active strength
13 g/100g; g/100g; g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10157-9539IInactivated by FDA2026-10-05
excluded packagepackage10157-953910157-9539-1IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10157-9539-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10157-9539-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10157-9539-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10157-9539-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10157-9539-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10157-9539-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10157-9539-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10157-9539-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10157-9539-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10157-9539-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10157-9539-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10157-9539-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10157-9539-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10157-9539-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10157-9539-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10157-9539-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10157-9539-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10157-9539-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10157-9539-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10157-9539-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage10157-9539-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage10157-9539-1110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10157-9539-12019-11-13C16284748780-197449f38-bed0-f6ea-e053-dbdaa90aa703Blistex ® European Formula Lip Conditioner™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-9539-1Blistex European Formula7 g in 1 JARPASTE72
10157-9539-1Blistex European Formula1 in 1 BLISTER PACKPASTE12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LanolinACTIVE INGREDIENT7EV65EAW6HBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
OctinoxateACTIVE INGREDIENT4Y5P7MUD51BLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
OxybenzoneACTIVE INGREDIENT95OOS7VE0YBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
LanolinACTIVE MOIETY7EV65EAW6HBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
OctinoxateACTIVE MOIETY4Y5P7MUD51BLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
OxybenzoneACTIVE MOIETY95OOS7VE0YBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0BLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
camphor (synthetic)INACTIVE INGREDIENT5TJD82A1ETBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
candelilla waxINACTIVE INGREDIENTWL0328HX19BLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
cocoa butterINACTIVE INGREDIENT512OYT1CRRBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
grape seed oilINACTIVE INGREDIENT930MLC8XGGBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
mentholINACTIVE INGREDIENTL7T10EIP3ABLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
microcrystalline waxINACTIVE INGREDIENTXOF597Q3KYBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
olive oilINACTIVE INGREDIENT6UYK2W1W1EBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
saccharinINACTIVE INGREDIENTFST467XS7DBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
thymolINACTIVE INGREDIENT3J50XA376EBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2
vanillinINACTIVE INGREDIENTCHI530446XBLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-9539BLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2Legacy NDC, 2 package rows20120319_197a2d5b-cd4b-431e-940b-f76684db7451.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
10157-9539-1101579539017 g in 1 JAR7 gHistorical