FDA.reportPublic FDA data

Application 083483

Type
ANDA
Sponsor
MILES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALCOHOL 5% IN DEXTROSE 5%ALCOHOLINJECTABLE;INJECTION5ML/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2021-12-28 21:50 UTC2021-12A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 1982ea99ee380514…

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 2 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Touchland Power Mist Spiced Pumpkin tini Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa809e-71b8-7498-e063-6394a90a9ff82026-09-04WarningsName fallback
generic name: ALCOHOL
Touchland Hello Kitty Power Mist Hand Sanitizer Berry BlissALCOHOLChurch & Dwight Co., Inc.5aaa8d3c-e386-1527-e063-6294a90a07ac2026-09-04WarningsName fallback
generic name: ALCOHOL
Touchland Power Mist Hydrating Hand Sanitizer Cinnamon GingerbreadALCOHOLChurch & Dwight Co., Inc.5aaa9d84-3f84-223e-e063-6294a90a79fb2026-09-04WarningsName fallback
generic name: ALCOHOL
Disney Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5aaab1c9-c25c-344a-e063-6294a90a228d2026-09-04WarningsName fallback
generic name: ALCOHOL
Touchland Power Mist Hydrating Hand Sanitizer Confetti CakeALCOHOLChurch & Dwight Co., Inc.5aaacef6-3b8b-ace4-e063-6394a90ab8592026-09-04WarningsName fallback
generic name: ALCOHOL
Disney Touchland Power Mist Hydrating Hand Sanitizer Vanilla BlossomALCOHOLChurch & Dwight Co., Inc.5aaae919-4adc-c146-e063-6394a90a89042026-09-04WarningsName fallback
generic name: ALCOHOL
Kuromi Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5aaaf5a5-d43f-cf23-e063-6394a90a72ef2026-09-04WarningsName fallback
generic name: ALCOHOL
Peanuts Touchland Power Mist Hydrating Hand Sanitizer Beach CocoALCOHOLChurch & Dwight Co., Inc.5aaaff8f-5f6b-d575-e063-6394a90a1edc2026-09-04WarningsName fallback
generic name: ALCOHOL
Touchland Power Mist Hydrating Hand Sanitizer Mist Midnight SmoresALCOHOLChurch & Dwight Co., Inc.5aab0ca1-b3c4-964f-e063-6294a90a263f2026-09-04WarningsName fallback
generic name: ALCOHOL
Touchland Power Mist Hydrating Hand Sanitizer Mist Cranberry FizzALCOHOLChurch & Dwight Co., Inc.5aab1faa-d884-1a55-e063-6394a90ad6e22026-09-04WarningsName fallback
generic name: ALCOHOL
biom Sanitizing Alcohol Wipes - Eucalyptus ChillALCOHOLBiom Innovations Inc23a89b5b-ee5f-4480-e063-6394a90a03b42026-09-02WarningsName fallback
generic name: ALCOHOL
Touchland Power Mist Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc5a8186f8-2f47-e57c-e063-6394a90a723a2026-09-02WarningsName fallback
generic name: ALCOHOL
Touchland Power Mist Hand Sanitizer Aloe YouALCOHOLChurch & Dwight Co., Inc.5a83e963-6a61-fa59-e063-6394a90ade6c2026-09-02WarningsName fallback
generic name: ALCOHOL
Touchland Power Mist Hand Sanitizer Berry BlissALCOHOLChurch & Dwight Co., Inc.5a83fc8f-31db-fd2a-e063-6294a90a8c432026-09-02WarningsName fallback
generic name: ALCOHOL
Touchland Power Mist Hand Sanitizer Blue SandalwoodALCOHOLChurch & Dwight Co., Inc.5a840981-765b-07f1-e063-6294a90ac6a32026-09-02WarningsName fallback
generic name: ALCOHOL
Touchland Power Mist Hand Sanitizer Citrus GroveALCOHOLChurch & Dwight Co., Inc.5a84344b-4ddb-32e5-e063-6394a90a628b2026-09-02WarningsName fallback
generic name: ALCOHOL
Touchland Power Mist Hand Sanitizer Frosted MintALCOHOLChurch & Dwight Co., Inc.5a8445e6-42cc-3e55-e063-6394a90ac0e12026-09-02WarningsName fallback
generic name: ALCOHOL
Touchland Power Mist Hand Sanitizer Lemon Lime SpritzALCOHOLChurch & Dwight Co., Inc.5a84870b-e539-9dd8-e063-6294a90aaf0b2026-09-02WarningsName fallback
generic name: ALCOHOL
Touchland Power Mist Hand Sanitizer Pure LavenderALCOHOLChurch & Dwight Co., Inc.5a848ff6-fbdd-a76c-e063-6294a90a324b2026-09-02WarningsName fallback
generic name: ALCOHOL
Touchland Power Mist Hand Sanitizer RainwaterALCOHOLChurch & Dwight Co., Inc.5a84969c-aa38-aeb7-e063-6294a90a69422026-09-02WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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