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 5 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olimpo AntibacterialBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.597e3b3e-51f0-5fcf-e063-6394a90ac2972026-08-20WarningsExact identifier
application number: M003
Benzalkonium ChlorideBENZALKONIUM CHLORIDE TOWELETTESTrifecta Pharmaceuticals USA LLC59811e67-57f0-4db1-e063-6294a90a2ad82026-08-20WarningsExact identifier
application number: M003
inControl alcoholISOPROPYL ALCOHOLH-E-B45dfbd7a-0ae1-4146-9527-5483c884e6362026-08-18WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEThe Kroger Co.52f6258f-4b4c-49f4-9bc7-40dc3918869d2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLThe Kroger Co.b127bba1-ce0b-4142-8b7d-f12f062b09382026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.cd3f8779-9e57-4b23-a029-7424d4d4ab2a2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.ca6c7f8a-d41a-4d77-817c-3dbdc40f890e2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Alcohol Sanitizer Spray.ETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fb9efe-43f0-1b7f-e063-6394a90a01452026-08-14WarningsExact identifier
application number: M003
Povidone-IodinePOVIDONE-IODINEMajor Pharmaceuticals59041ca3-a195-5a20-e063-6394a90a2ac92026-08-14WarningsExact identifier
application number: M003
Alcohol Hand SanitizerETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fa90dc-c3b5-787b-e063-6294a90a2e172026-08-13WarningsExact identifier
application number: M003
SprinJeneALCOHOLHealth and Natural Beauty USA Corp1853f023-f4db-4cd8-a4df-a439bc306cc32026-08-13WarningsExact identifier
application number: M003
LUXURY IPA 70%LUXURY ISOPROPYL ALCOHOL 70% 16OZTSM BRANDS LLC2240a9e0-dac5-54fa-e063-6394a90a35f52026-08-11WarningsExact identifier
application number: M003
Ethyl alcoholETHYL ALCOHOLStrategic Sourcing Services LLC4fec6f1f-0249-423f-bd3c-427aa6924c6f2026-08-10Warnings, Adverse reactionsExact identifier
application number: M003
antibacterial hand wipes (JUICY WATERMELON)ANTIBACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.5883c43d-212b-af39-e063-6394a90ad6522026-08-08WarningsExact identifier
application number: M003
LIGHTS Antiseptic and Pain Relieving Prep PadISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.91cc7334-f610-487d-a895-3dda78c3372e2026-08-07WarningsExact identifier
application number: M003
CVS Beauty Hydrating Hand Sanitizer SANDALWOOD MUSKETHYL ALCOHOLCVS Pharmacy, Inc.60128fc3-b127-44ee-9e9b-384d322d213a2026-08-07WarningsExact identifier
application number: M003
CVS Beauty Hydrating Hand Sanitizer Sea Salt and LavenderETHYL ALCOHOLCVS Pharmacy, Inc.6c160826-ad98-4390-a07b-c92a2ae5b1812026-08-07WarningsExact identifier
application number: M003
antibacterial hand wipes (2257C)ANTIBACTERIAL HAND WIPES (2257C)Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585a1c36-7bdc-4d4f-e063-6394a90ad6d22026-08-06WarningsExact identifier
application number: M003
antibacterial hand wipes (Angel)ANTIBACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585c4a14-8dc9-3a08-e063-6394a90ab4f52026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer ROSEWATER SPRITZALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585cb4fa-6016-1550-e063-6294a90a514d2026-08-06WarningsExact 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