FDA.reportPublic FDA data

PRIME

Product NDC
79382-001
11-digit product format
793820001
Labeler code
79382
Product ID
79382-001_a5ca392e-9e7f-4259-b2eb-90e6197dee89
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Prime Industries Usa, Inc
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-26
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79382-001-012021-07-23C16284748780-1c7ccaba7-271b-fd44-e053-dadaa90aa01bf2f03954-f47c-43f7-be63-376959b2059e
79382-001-022021-07-23C16284748780-1c7ccaba7-271b-fd44-e053-dadaa90aa01bf2f03954-f47c-43f7-be63-376959b2059e
79382-001-032021-07-23C16284748780-1c7ccaba7-271b-fd44-e053-dadaa90aa01bf2f03954-f47c-43f7-be63-376959b2059e
79382-001-042021-07-23C16284748780-1c7ccaba7-271b-fd44-e053-dadaa90aa01bf2f03954-f47c-43f7-be63-376959b2059e
79382-001-052021-07-23C16284748780-1c7ccaba7-271b-fd44-e053-dadaa90aa01bf2f03954-f47c-43f7-be63-376959b2059e
79382-001-062021-07-23C16284748780-1c7ccaba7-271b-fd44-e053-dadaa90aa01bf2f03954-f47c-43f7-be63-376959b2059e
79382-001-072021-07-23C16284748780-1c7ccaba7-271b-fd44-e053-dadaa90aa01bf2f03954-f47c-43f7-be63-376959b2059e
79382-001-082021-07-23C16284748780-1c7ccaba7-271b-fd44-e053-dadaa90aa01bf2f03954-f47c-43f7-be63-376959b2059e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79382-001-01PRIME30 mL in 1 BOTTLE, PLASTICGEL302
79382-001-02PRIME60 mL in 1 BOTTLE, PLASTICGEL602
79382-001-03PRIME100 mL in 1 BOTTLE, PLASTICGEL1002
79382-001-04PRIME237 mL in 1 BOTTLE, PLASTICGEL2372
79382-001-05PRIME500 mL in 1 BOTTLE, PLASTICGEL5002
79382-001-06PRIME1000 mL in 1 DRUMGEL10002
79382-001-07PRIME5000 mL in 1 DRUMGEL50002
79382-001-08PRIME200000 mL in 1 DRUMGEL2000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79382-001PRIME (ALCOHOL) GEL [PRIME INDUSTRIES USA, INC]2Legacy NDC, 8 package rows20200807_f2f03954-f47c-43f7-be63-376959b2059e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNf2f03954-f47c-43f7-be63-376959b2059e2
1305100ethanol 0.75 ML/ML Topical GelSCDf2f03954-f47c-43f7-be63-376959b2059e2
1305100ethanol 75 % Topical GelSYf2f03954-f47c-43f7-be63-376959b2059e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79382-001-017938200010130 mL in 1 BOTTLE, PLASTIC (79382-001-01) 30 ml2020-06-260000-00-00NoNoCurrent
79382-001-027938200010260 mL in 1 BOTTLE, PLASTIC (79382-001-02) 60 ml2020-06-260000-00-00NoNoCurrent
79382-001-0379382000103100 mL in 1 BOTTLE, PLASTIC (79382-001-03) 100 ml2020-06-260000-00-00NoNoCurrent
79382-001-0479382000104237 mL in 1 BOTTLE, PLASTIC (79382-001-04) 237 ml2020-06-260000-00-00NoNoCurrent
79382-001-0579382000105500 mL in 1 BOTTLE, PLASTIC (79382-001-05) 500 ml2020-06-260000-00-00NoNoCurrent
79382-001-06793820001061000 mL in 1 DRUM (79382-001-06) 1000 ml2020-06-260000-00-00NoNoCurrent
79382-001-07793820001075000 mL in 1 DRUM (79382-001-07) 5000 ml2020-06-260000-00-00NoNoCurrent
79382-001-0879382000108200000 mL in 1 DRUM (79382-001-08) 200000 ml2020-06-260000-00-00NoNoCurrent