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 2 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WalmartISOPROPYL ALCOHOLWalmart, Inc.2eff98ba-5736-b07e-e063-6394a90aeea92026-09-04WarningsExact identifier
application number: M003
Walgreen AlcoholISOPROPYL ALCOHOLWalgreens Companydeeae1ea-3d81-4260-95be-c4f328e3fdef2026-09-04WarningsExact identifier
application number: M003
Dollar GeneralISOPROPYL ALCOHOLDollar General Corporation00b2ef34-42d9-523c-e063-6294a90a753d2026-09-03WarningsExact identifier
application number: M003
Signature Select Alcohol Prep PadsISOPROPYL ALCOHOLBetter Living Brands LLC31ce72e3-03a3-1608-e063-6394a90ad8502026-09-03WarningsExact identifier
application number: M003
SurviveX Sting ReliefSTING RELIEF WIPEChangzhou Maokang Medical Products Co., Ltd.5a83b1f1-c8dc-cf07-e063-6394a90a20ca2026-09-03WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEKroger Co.fe604470-917f-4cbd-a1e6-ac1dc7c57ff62026-09-02WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLRite Aid Corporation5104f9ab-0b28-449f-a55a-5438713a24df2026-09-02WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEUpLift Brands, LLC5a81b635-d188-0b29-e063-6294a90a1e4b2026-09-02Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDECVS Pharmacy, Inc.7f518646-c8fe-499a-b5e4-8e5a5a90e01d2026-09-02Warnings, Adverse reactionsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLThe Kroger Company6551187f-5cde-4149-931f-b057bd7607502026-09-02WarningsExact identifier
application number: M003
Unscented NasalGuard Antiseptic TopicalBENZALKONIUM CHLORIDETRUTEK CORP.eb036e11-a28c-fdc0-e053-2a95a90a9cdb2026-09-02WarningsExact identifier
application number: M003
Harris TeeterISOPROPYL ALCOHOLHarris Teeter, LLCd2bb20bd-ec83-8d80-e053-2a95a90a2bba2026-09-02WarningsExact identifier
application number: M003
School HealthISOPROPYL ALCOHOLSchool Health Corporationdb5d0b22-f2d7-23e5-e053-2a95a90aeb512026-09-02WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLTopco Associates2642298f-607e-fdca-e063-6394a90a69d92026-09-02WarningsExact identifier
application number: M003
HUSTLE BUTTER NUMBINGLIDOCAINE HCL, BENZALKONIUM CHLORIDEH.B.D. DIST. INC.5b4d0390-dac6-4a71-9fdc-5c31543e7c5a2026-09-02WarningsExact identifier
application number: M003
NasalGuard Antiseptic Topical Cool MentholBENZALKONIUM CHLORIDETRUTEK CORP.e9fd3ef8-78ff-6c9f-e053-2a95a90a21a82026-09-01WarningsExact identifier
application number: M003
Maximum Strength Betadine ClearBENZALKONIUM CL AND PRAMOXINE HCLAtlantis Consumer Healthcare, Inc.31b94a76-1536-47c0-ab03-e487c2625c582026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a28101f-ea8e-6071-e063-6294a90aad912026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a3e62ce-52dc-121b-e063-6294a90a898f2026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a49db18-c270-6f46-e063-6294a90afb5d2026-08-31WarningsExact 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