FDA.reportPublic FDA data

PUROMA

Product NDC
80948-002
11-digit product format
809480002
Labeler code
80948
Product ID
80948-002_d94bffbc-0b47-0f29-e053-2a95a90ade01
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
ZENITH MICRO CONTROL
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-12-20
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80948-002-012025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-022025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-032025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-042025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-052025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-062025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-072025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-082025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-092025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-102025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-112025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-122025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-132025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-142025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-152025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-162025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer
80948-002-172025-01-30C16284748780-12cef2736-afda-d83d-e063-dadaa90ab31fPUROMA Ethyl Alcohol 70% Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80948-002-01PUROMA30 mL in 1 BOTTLEGEL305
80948-002-02PUROMA60 mL in 1 BOTTLEGEL605
80948-002-03PUROMA50 mL in 1 BOTTLEGEL505
80948-002-04PUROMA100 mL in 1 BOTTLEGEL1005
80948-002-05PUROMA120 mL in 1 BOTTLEGEL1205
80948-002-06PUROMA320 mL in 1 BOTTLEGEL3205
80948-002-07PUROMA503 mL in 1 BOTTLEGEL5035
80948-002-08PUROMA5000 mL in 1 CANGEL50005
80948-002-09PUROMA50000 mL in 1 CANGEL500005
80948-002-10PUROMA200000 mL in 1 DRUMGEL2000005
80948-002-11PUROMA30 mL in 1 BOTTLEGEL305
80948-002-11PUROMA12 in 1 PACKAGEGEL125
80948-002-12PUROMA6 in 1 PACKAGEGEL65
80948-002-12PUROMA60 mL in 1 BOTTLEGEL605
80948-002-13PUROMA4 in 1 PACKAGEGEL45
80948-002-13PUROMA237 mL in 1 BOTTLEGEL2375
80948-002-14PUROMA237 mL in 1 BOTTLEGEL2375
80948-002-15PUROMA488 mL in 1 BOTTLEGEL4885
80948-002-16PUROMA488 mL in 1 BOTTLEGEL4885
80948-002-16PUROMA2 in 1 PACKAGEGEL25
80948-002-17PUROMA947 mL in 1 BOTTLEGEL9475

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80948-002PUROMA (ALCOHOL) GEL [ZENITH MICRO CONTROL]5Legacy NDC, 21 package rows20231214_8825ca11-1e99-491f-9dfc-a282ded85c96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN8825ca11-1e99-491f-9dfc-a282ded85c965
581662ethanol 0.7 ML/ML Topical GelSCD8825ca11-1e99-491f-9dfc-a282ded85c965
581662ethanol 70 % Topical GelSY8825ca11-1e99-491f-9dfc-a282ded85c965
581662ethyl alcohol 70 % Topical GelSY8825ca11-1e99-491f-9dfc-a282ded85c965

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80948-002-018094800020130 mL in 1 BOTTLE (80948-002-01) 30 ml2020-12-200000-00-00NoNoCurrent
80948-002-028094800020260 mL in 1 BOTTLE (80948-002-02) 60 ml2020-12-200000-00-00NoNoCurrent
80948-002-038094800020350 mL in 1 BOTTLE (80948-002-03) 50 ml2020-12-200000-00-00NoNoCurrent
80948-002-0480948000204100 mL in 1 BOTTLE (80948-002-04) 100 ml2020-12-200000-00-00NoNoCurrent
80948-002-0580948000205120 mL in 1 BOTTLE (80948-002-05) 120 ml2020-12-200000-00-00NoNoCurrent
80948-002-0680948000206320 mL in 1 BOTTLE (80948-002-06) 320 ml2020-12-200000-00-00NoNoCurrent
80948-002-0780948000207503 mL in 1 BOTTLE (80948-002-07) 503 ml2020-12-200000-00-00NoNoCurrent
80948-002-08809480002085000 mL in 1 CAN (80948-002-08) 5000 ml2020-12-200000-00-00NoNoCurrent
80948-002-098094800020950000 mL in 1 CAN (80948-002-09) 50000 ml2020-12-200000-00-00NoNoCurrent
80948-002-1080948000210200000 mL in 1 DRUM (80948-002-10) 200000 ml2020-12-200000-00-00NoNoCurrent
80948-002-118094800021112 BOTTLE in 1 PACKAGE (80948-002-11) > 30 mL in 1 BOTTLE12 bottle2021-10-210000-00-00NoNoCurrent
80948-002-12809480002126 BOTTLE in 1 PACKAGE (80948-002-12) > 60 mL in 1 BOTTLE6 bottle2021-10-210000-00-00NoNoCurrent
80948-002-13809480002134 BOTTLE in 1 PACKAGE (80948-002-13) > 237 mL in 1 BOTTLE4 bottle2021-10-210000-00-00NoNoCurrent
80948-002-1480948000214237 mL in 1 BOTTLE (80948-002-14) 237 ml2021-10-210000-00-00NoNoCurrent
80948-002-1580948000215488 mL in 1 BOTTLE (80948-002-15) 488 ml2021-10-210000-00-00NoNoCurrent
80948-002-16809480002162 BOTTLE in 1 PACKAGE (80948-002-16) > 488 mL in 1 BOTTLE2 bottle2021-10-210000-00-00NoNoCurrent
80948-002-1780948000217947 mL in 1 BOTTLE (80948-002-17) 947 ml2021-10-210000-00-00NoNoCurrent