FDA.reportPublic FDA data

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

Product NDC
30400-101
11-digit product format
304000101
Labeler code
30400
Product ID
30400-101_5d13cdab-e1b8-484f-e063-6294a90a4c30
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Jell Pharmaceuticals Pvt. Ltd.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-18
Substance
ISOPROPYL ALCOHOL
Active strength
50 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL50 mL/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30400-101-01ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN119 mL in 1 BOTTLE, PLASTICLIQUID1192
30400-101-02ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN178 mL in 1 BOTTLE, PLASTICLIQUID1782
30400-101-03ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN237 mL in 1 BOTTLE, PLASTICLIQUID2372
30400-101-04ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN295 mL in 1 BOTTLE, PLASTICLIQUID2952
30400-101-05ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN354 mL in 1 BOTTLE, PLASTICLIQUID3542
30400-101-06ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN414 mL in 1 BOTTLE, PLASTICLIQUID4142
30400-101-07ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN473 mL in 1 BOTTLE, PLASTICLIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30400-101ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [JELL PHARMACEUTICALS PVT. LTD.]2Current NDC, Legacy NDC, 7 package rows20241219_f15a16ce-85e0-473f-e053-2a95a90ae89c.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 105 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guardian VaginalBENZALKONIUM CHLORIDEEastern Century Pharmaceuticals1605ba44-02b7-4c72-9fec-89a5aa962b442024-04-24WarningsExact identifier
application number: M003
Inverness Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.0ccd72e7-16a2-47c7-9ce6-dffb63a0344b2024-04-18WarningsExact identifier
application number: M003
Lovisa Piercing Care SolutionBENZALKONIUM CHLORIDEThe Richline Group, Inc.74f46b81-cc5b-4e3f-a36e-0bd86d370c222024-04-18WarningsExact identifier
application number: M003
CliniClean BZK Cleansing Contains Benzalkonium ChlorideBENZALKONIUM CHLORIDEHR HealthCareb6916466-0931-408f-a430-0797a449c32e2024-04-18WarningsExact identifier
application number: M003
Handy Solutions First Aid KitBENZALKONIUM CHLORIDENavajo Manufacturing Company Inc.130237ff-3db4-1288-e063-6394a90ab1af2024-04-16WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEHenry Schein Inc.ff877b63-fa58-4770-a882-694eda33203b2024-04-02WarningsExact identifier
application number: M003
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine HydrochlorideBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.8e1f35ff-d4e6-4940-ad8f-dce2b73e595d2024-04-01WarningsExact identifier
application number: M003
Antiseptic Towelette TOALLITAS ANTISEPTICASBENZALKONIUM CHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.b267e186-cf7a-458f-9c28-a48a8554af402024-04-01WarningsExact identifier
application number: M003
Antiseptic Povidone Iodine Prep PadPOVIDONE-IODINEM-star (Hubei) Health&Care Products Co., Ltd.fc76c1f3-b48e-4276-890d-5b8e5a894e622024-04-01WarningsExact identifier
application number: M003
Novex Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.8b53dde5-c9f6-41c4-8ddb-bf0bf67008d32024-03-20WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDE 0.13%Trifecta Pharmaceuticals USA, LLC.13f1c70f-3b44-8eef-e063-6294a90af6342024-03-18WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC1308ce91-2858-310a-e063-6394a90a68102024-03-06WarningsExact identifier
application number: M003
Instant Hand Sanitizer - Cocoa ButterETHYL ALCOHOLRejoice International, Inc.97dee45e-53be-4b37-a427-fc24388c0e052024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer Aloe VeraETHYL ALCOHOLRejoice International, Inc.1e28454c-f5d8-4d6e-91f9-bc4501b027c12024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - ClearETHYL ALCOHOLRejoice International, Inc.f0e637d9-d61e-466d-9e05-f906639dbaca2024-02-28WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International, Inc.07b163e4-8f67-44e7-b5ef-f237023080e02024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - Ice ClearETHYL ALCOHOLRejoice International, Inc.605ec88a-2f4c-4716-8522-eb2748b433982024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - OriginalETHYL ALCOHOLRejoice International, Inc.bb9cc886-275e-4996-99dc-529f928b49052024-02-28WarningsExact identifier
application number: M003
Liquid Hand CleanseTRICLOSANRejoice International, Inc.23ff5450-8308-41c0-9052-1ac4c4433d6c2024-02-28WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse OriginalTRICLOSANRejoice International, Inc.b5ce6663-fe82-4da1-923e-acea293d7a002024-02-28WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616456isopropyl alcohol 50 % Topical SolutionPSNf15a16ce-85e0-473f-e053-2a95a90ae89c2
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCDf15a16ce-85e0-473f-e053-2a95a90ae89c2
616456isopropyl alcohol 50 % Topical SolutionSYf15a16ce-85e0-473f-e053-2a95a90ae89c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30400-101-0130400010101119 mL in 1 BOTTLE, PLASTIC (30400-101-01) 119 ml2020-06-180000-00-00NoNoCurrent
30400-101-0230400010102178 mL in 1 BOTTLE, PLASTIC (30400-101-02) 178 ml2020-06-180000-00-00NoNoCurrent
30400-101-0330400010103237 mL in 1 BOTTLE, PLASTIC (30400-101-03) 237 ml2020-06-180000-00-00NoNoCurrent
30400-101-0430400010104295 mL in 1 BOTTLE, PLASTIC (30400-101-04) 295 ml2020-06-180000-00-00NoNoCurrent
30400-101-0530400010105354 mL in 1 BOTTLE, PLASTIC (30400-101-05) 354 ml2020-06-180000-00-00NoNoCurrent
30400-101-0630400010106414 mL in 1 BOTTLE, PLASTIC (30400-101-06) 414 ml2020-06-180000-00-00NoNoCurrent
30400-101-0730400010107473 mL in 1 BOTTLE, PLASTIC (30400-101-07) 473 ml2020-06-180000-00-00NoNoCurrent
30400-101-0830400010108907 mL in 1 BOTTLE, PLASTIC (30400-101-08) 907 ml2020-06-18NoNoCurrent