FDA.reportPublic FDA data

Refill 6

Product NDC
49687-0019
11-digit product format
496870019
Labeler code
49687
Product ID
49687-0019_2ba1a752-8549-47e2-e063-6394a90a54d5
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL, WATER
Dosage form
KIT
Labeler
CMC Group, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-10
NDC exclude flag
No
Listing certified through
2026-12-31
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
Refill 6
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581660Internal RxNorm lookup
1053429Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7849ae59-5484-4b86-a0b9-ec9b93d9afe0Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49687-0019-02020-02-04C16284748780-19d75b9cf-ebe5-f424-e053-dadaa90a57ceRefill 6
49687-0019-02020-01-31C16284748780-19d75b9cf-ebe5-f424-e053-dadaa90a57ceRefill 6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49687-0010-1Refill 630 mL in 1 TUBESOLUTION30 mL991 mg in 1mL11
49687-0010-1Refill 61 in 1 BOXSOLUTION991 mg in 1mL11
49687-0015-0Refill 60.9 g in 1 BOTTLEGEL5.4 g0.62 g in 1g11
49687-0015-0Refill 66 in 1 KITGEL0.62 g in 1g11
49687-0019-0Refill 61 in 1 KITKIT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49687-0019REFILL 6 (ALCOHOL, WATER) KIT [CMC GROUP, INC.]11Current NDC, Legacy NDC, 5 package rows20250115_7849ae59-5484-4b86-a0b9-ec9b93d9afe0.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 4 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentian VioletGENTIAN VIOLETVitamex USA, Corp21742061-fc0b-f750-e063-6394a90a75082026-08-26WarningsExact identifier
application number: M003
MercurochromeBENZALKONIUM CHLORIDEVitamex USA, Corp21652b11-715d-0c54-e063-6294a90a88552026-08-26WarningsExact identifier
application number: M003
Scentsational Square Hand SanitizerHAND SANITIZERRaining Rose, Inc.59f9bacf-80dc-3468-e063-6294a90a0ae12026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fa27b4-dfd4-720b-e063-6394a90af6592026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fb22d6-f6a4-42cd-e063-6394a90a859a2026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fbb054-461e-aa6e-e063-6394a90a470c2026-08-26WarningsExact identifier
application number: M003
Curad Alcohol Sterile, ThickISOPROPYL ALCOHOLMedline Industries, LPb769898e-a73f-4323-af15-bee8dbe455b62026-08-25WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEYour Military Exchangesa71734c6-6b92-4d3d-84d1-a07f592fa8282026-08-25Warnings, Adverse reactionsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e742a6-61f9-59f7-e063-6394a90a87382026-08-25WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e7dfb1-49b5-d2be-e063-6394a90a04d82026-08-25WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d3c369-86aa-8ebd-e063-6394a90aa8062026-08-24WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d7fc3c-3a93-153d-e063-6394a90ac6472026-08-24WarningsExact identifier
application number: M003
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Inc23d0dc62-28d6-4d1f-a7d5-4b14f5c9fb1e2026-08-24WarningsExact identifier
application number: M003
ClaravieBENZALKONIUM CHLORIDEGentell LLC59887af3-9b22-9664-e063-6294a90a57c62026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light blue 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a96f0-33fe-40aa-e063-6394a90aeacb2026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light green 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a165a-90ff-e00c-e063-6394a90a33512026-08-21WarningsExact identifier
application number: M003
Family Beauty Antibacterial Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.6ff604f7-4011-4f0e-aa2d-a46e1a973d132026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light purple 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598b7bb8-0d2e-a66f-e063-6294a90a45b82026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light yellow 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598bf8cd-2a79-8b56-e063-6394a90a42a82026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light pink 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598c41f0-908d-df52-e063-6394a90a3c8d2026-08-21WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN7849ae59-5484-4b86-a0b9-ec9b93d9afe011
1053429water 99.1 % Ophthalmic Irrigation SolutionPSN7849ae59-5484-4b86-a0b9-ec9b93d9afe011
581660ethanol 0.62 ML/ML Topical GelSCD7849ae59-5484-4b86-a0b9-ec9b93d9afe011
1053429water 991 MG/ML Ophthalmic Irrigation SolutionSCD7849ae59-5484-4b86-a0b9-ec9b93d9afe011
581660ethanol 62 % Topical GelSY7849ae59-5484-4b86-a0b9-ec9b93d9afe011
1053429water 99.05 % Ophthalmic Irrigation SolutionSY7849ae59-5484-4b86-a0b9-ec9b93d9afe011
1053429water 99.1 % Ophthalmic Irrigation SolutionSY7849ae59-5484-4b86-a0b9-ec9b93d9afe011
1053429water 99.1 ML per 100 ML Ophthalmic Irrigation SolutionSY7849ae59-5484-4b86-a0b9-ec9b93d9afe011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49687-0010-14968700100130 mL in 1 TUBE30 mlHistorical
49687-0015-0496870015000.9 g in 1 BOTTLE0.9 gHistorical
49687-0019-0496870019001 KIT in 1 KIT (49687-0019-0) * 6 BOTTLE in 1 KIT (49687-0015-0) / .9 g in 1 BOTTLE * 1 TUBE in 1 BOX (49687-0010-1) / 30 mL in 1 TUBE1 kit2016-08-100000-00-00NoNoCurrent