FDA.reportPublic FDA data

XtraCare Sweet Pea Blossom

Product NDC
57337-073
Requested package NDC
57337-073-01
11-digit product format
573370073
Labeler code
57337
Product ID
57337-073_2ded2d03-5373-6f46-e063-6294a90a971f
Type
HUMAN OTC DRUG
Nonproprietary name
ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Rejoice International
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-17
Substance
ALCOHOL
Active strength
62 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57337-07357337-073-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57337-07357337-073-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57337-07357337-073-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
XtraCare Sweet Pea Blossom
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581660Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a5408f2-910c-4c6a-b6b3-c1304dd1cdf0Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-073-012025-02-12C16284748780-12cef2736-9ebe-d83d-e063-dadaa90ab31fXtraCare Sweet Pea Blossom
57337-073-012025-01-30C16284748780-12cef2736-9ebe-d83d-e063-dadaa90ab31fXtraCare Sweet Pea Blossom

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-073-01XtraCare Sweet Pea Blossom237 g in 1 BOTTLEGEL2373

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MXTRACARE SWEET PEA BLOSSOM (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
ALCOHOLACTIVE MOIETY3K9958V90MXTRACARE SWEET PEA BLOSSOM (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE SWEET PEA BLOSSOM (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LXTRACARE SWEET PEA BLOSSOM (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LXTRACARE SWEET PEA BLOSSOM (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE SWEET PEA BLOSSOM (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XTRACARE SWEET PEA BLOSSOM (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKXTRACARE SWEET PEA BLOSSOM (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE SWEET PEA BLOSSOM (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-073XTRACARE SWEET PEA BLOSSOM (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20250214_1a5408f2-910c-4c6a-b6b3-c1304dd1cdf0.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 56 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7326-d300-a845-e063-6394a90a39aa2025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d8811-7fb2-aef6-e063-6394a90a1cf82025-10-27WarningsExact identifier
application number: M003
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)MY IMPORTS USA LLC421d7bd9-c893-ec97-e063-6394a90a4b282025-10-27WarningsExact identifier
application number: M003
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)MY IMPORTS USA LLC421dc192-97ed-0675-e063-6394a90aa1562025-10-27WarningsExact identifier
application number: M003
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)MY IMPORTS USA LLC421f3150-2027-c6aa-e063-6294a90ab6aa2025-10-27WarningsExact identifier
application number: M003
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.421b402e-233d-cebf-e063-6394a90aa4212025-10-27WarningsExact identifier
application number: M003
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.637dcb5f-8870-4613-a227-9fd6126170612025-10-27WarningsExact identifier
application number: M003
SOURPATCH KIDS HAND SANITIZER SET WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42143916-8d2e-dbbe-e063-6294a90a29c42025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER SET CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42147184-18e6-f932-e063-6294a90a807e2025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4214ba08-8d00-8de9-e063-6394a90a4c902025-10-26WarningsExact identifier
application number: M003
Sour Patch Kids Hand Sanitizer WatermelonALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4214f0de-6b1d-dae7-e063-6294a90ade422025-10-26WarningsExact identifier
application number: M003
SOURPATCH KIDS HAND SANITIZER STRAWBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4215130c-a298-02c7-e063-6394a90a74ff2025-10-26WarningsExact identifier
application number: M003
SMARTIES ORANGE HAND SANTIZER SET ORANGE CREAMSICLEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd421b1732-acdd-a6cc-e063-6394a90a5fb42025-10-26WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Soft BerryETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421ce569-f2d3-c1e0-e063-6294a90a822f2025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER BLUE RASPBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d1f66d-45f6-bb9a-e063-6394a90a06aa2025-10-26WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLCardinal Healthc95bfab6-bab4-79f3-e053-2995a90a80912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6e97d7-7eea-f7ca-e063-6394a90a4ecd2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6cabf7-9310-cba5-e063-6394a90a3f912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC39529f87-ed4e-52b8-e063-6394a90af8792025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLPhoenix Healthcare Solutions LLCf0b55f6c-4afd-2154-e053-2995a90afcfa2025-10-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN1a5408f2-910c-4c6a-b6b3-c1304dd1cdf03
581660ethanol 0.62 ML/ML Topical GelSCD1a5408f2-910c-4c6a-b6b3-c1304dd1cdf03
581660ethanol 62 % Topical GelSY1a5408f2-910c-4c6a-b6b3-c1304dd1cdf03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-073-0157337007301237 g in 1 BOTTLE (57337-073-01) 237 g2015-02-170000-00-00NoNoCurrent