Fruit Smoothies

Product NDC
10157-8009
11-digit product format
101578009
Labeler code
10157
Product ID
10157-8009_b1492fa2-6f92-4bf8-8270-e5b01d5217af
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone, Octinoxate, and Oxybenzone
Dosage form
KIT
Labeler
Blistex Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-09-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct10157-8009IInactivated by FDA2026-10-16
excluded packagepackage10157-800910157-8009-1IInactivated by FDA2026-10-16

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 · 42 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 packagepackage10157-8009-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10157-8009-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10157-8009-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10157-8009-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10157-8009-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10157-8009-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10157-8009-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10157-8009-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10157-8009-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10157-8009-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10157-8009-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10157-8009-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10157-8009-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10157-8009-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10157-8009-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10157-8009-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10157-8009-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10157-8009-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10157-8009-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10157-8009-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage10157-8009-19bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10157-8009-12020-01-31C16284748780-19d75b9d0-db82-f424-e053-dadaa90a57ceFruit Smoothies ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-8009-1Fruit Smoothies1 in 1 BLISTER PACKKIT11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DimethiconeACTIVE INGREDIENT92RU3N3Y1OFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
OctinoxateACTIVE INGREDIENT4Y5P7MUD51FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
DimethiconeACTIVE MOIETY92RU3N3Y1OFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
OctinoxateACTIVE MOIETY4Y5P7MUD51FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
OxybenzoneACTIVE MOIETY95OOS7VE0YFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
D&C red no. 30INACTIVE INGREDIENT2S42T2808BFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
diethylhexyl adipateINACTIVE INGREDIENTMBY1SL921LFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
ethylhexyl palmitateINACTIVE INGREDIENT2865993309FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
ethylhexyl stearateINACTIVE INGREDIENTEG3PA2K3K5FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
high density polyethyleneINACTIVE INGREDIENTUG00KM4WR7FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
hydrogenated coconut oilINACTIVE INGREDIENTJY81OXM1OMFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
isopropyl stearateINACTIVE INGREDIENT43253ZW1MZFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
microcrystalline waxINACTIVE INGREDIENTXOF597Q3KYFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
myristyl myristateINACTIVE INGREDIENT4042ZC00DYFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
phenyl trimethiconeINACTIVE INGREDIENTDR0K5NOJ4RFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
saccharinINACTIVE INGREDIENTFST467XS7DFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
tetrahexyldecyl ascorbateINACTIVE INGREDIENT9LBV3F07AZFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1
yellow waxINACTIVE INGREDIENT2ZA36H0S2VFRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-8009FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]1Legacy NDC, 1 package rows20130904_38d7b411-41e3-406f-be6a-9d65272d6a45.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10157-8009-1101578009011 in 1 BLISTER PACKHistorical