FDA.reportPublic FDA data

Isopropyl Rubbing Alcohol 99%

Product NDC
52000-049
11-digit product format
520000049
Labeler code
52000
Product ID
52000-049_1fa8abd7-c0fd-47e9-920d-ed5217a52b7c
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-20
Substance
ISOPROPYL ALCOHOL
Active strength
99 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 99%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL99 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
402481Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
678a9b14-2838-4358-9673-fc23e0f58efbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-049-01Isopropyl Rubbing Alcohol 99%118 mL in 1 BOTTLE, PLASTICLIQUID1182
52000-049-02Isopropyl Rubbing Alcohol 99%177 mL in 1 BOTTLE, PLASTICLIQUID1772
52000-049-03Isopropyl Rubbing Alcohol 99%237 mL in 1 BOTTLE, PLASTICLIQUID2372
52000-049-04Isopropyl Rubbing Alcohol 99%296 mL in 1 BOTTLE, PLASTICLIQUID2962
52000-049-05Isopropyl Rubbing Alcohol 99%355 mL in 1 BOTTLE, PLASTICLIQUID3552
52000-049-06Isopropyl Rubbing Alcohol 99%414 mL in 1 BOTTLE, PLASTICLIQUID4142
52000-049-07Isopropyl Rubbing Alcohol 99%473 mL in 1 BOTTLE, PLASTICLIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-049ISOPROPYL RUBBING ALCOHOL 99% (ISOPROPYL ALCOHOL) LIQUID [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 7 package rows20241212_678a9b14-2838-4358-9673-fc23e0f58efb.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 104 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safly BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.5cd9043e-daf2-43eb-9568-54775fc4f84a2024-05-15WarningsExact identifier
application number: M003
Noshinku Bergamot Hand SanitizerALCOHOLNoshinku53fea81e-4482-6fae-e054-00144ff8d46c2024-05-14WarningsExact identifier
application number: M003
Noshinku Eucalyptus Hand SanitizerALCOHOLNoshinku9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c02024-05-14WarningsExact identifier
application number: M003
Noshinku Lavender Hand SanitizerALCOHOLNoshinkua57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf2024-05-14WarningsExact identifier
application number: M003
LEADER 2% Mild Iodine TinctureIODINE AND SODIUM IODIDE AND ALCOHOL LIQUIDCardinal Health, 110 dba Leader7f810b92-60f6-2f72-e053-2991aa0ab9732024-05-13WarningsExact identifier
application number: M003
Leader Decolorized IodineALCOHOL LIQUIDCardinal Health, 110 dba Leader822f6f28-956f-dd82-e053-2991aa0ae7522024-05-13WarningsExact identifier
application number: M003
Inverness Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a2995-334c-2e93-e063-6294a90aecf72024-05-09WarningsExact identifier
application number: M003
Helzberg Diamonds Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a3776-0edd-26f3-e063-6294a90a740d2024-05-09WarningsExact identifier
application number: M003
Ulta Beauty Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a37f4-8718-3e40-e063-6294a90acaad2024-05-09WarningsExact identifier
application number: M003
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402481isopropyl alcohol 99 % Topical SolutionPSN678a9b14-2838-4358-9673-fc23e0f58efb2
402481isopropyl alcohol 0.99 ML/ML Topical SolutionSCD678a9b14-2838-4358-9673-fc23e0f58efb2
402481isopropyl alcohol 99 % Topical SolutionSY678a9b14-2838-4358-9673-fc23e0f58efb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-049-0152000004901118 mL in 1 BOTTLE, PLASTIC (52000-049-01) 118 ml2020-05-200000-00-00NoNoCurrent
52000-049-0252000004902177 mL in 1 BOTTLE, PLASTIC (52000-049-02) 177 ml2020-05-200000-00-00NoNoCurrent
52000-049-0352000004903237 mL in 1 BOTTLE, PLASTIC (52000-049-03) 237 ml2020-05-200000-00-00NoNoCurrent
52000-049-0452000004904296 mL in 1 BOTTLE, PLASTIC (52000-049-04) 296 ml2020-05-200000-00-00NoNoCurrent
52000-049-0552000004905355 mL in 1 BOTTLE, PLASTIC (52000-049-05) 355 ml2020-05-200000-00-00NoNoCurrent
52000-049-0652000004906414 mL in 1 BOTTLE, PLASTIC (52000-049-06) 414 ml2020-05-200000-00-00NoNoCurrent
52000-049-0752000004907473 mL in 1 BOTTLE, PLASTIC (52000-049-07) 473 ml2020-05-200000-00-00NoNoCurrent