FDA.reportPublic FDA data

Prosanca

Product NDC
77838-116
11-digit product format
778380116
Labeler code
77838
Product ID
77838-116_d3b31d41-fec4-52a6-e053-2995a90ad3fd
Type
HUMAN OTC DRUG
Nonproprietary name
70% Ethanol
Dosage form
SPRAY
Route
TOPICAL
Labeler
proem group
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-01-15
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct77838-116IInactivated by FDA2026-07-31
excluded packagepackage77838-11677838-116-15IInactivated by FDA2026-07-31
excluded packagepackage77838-11677838-116-16IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MistALCOHOLDerma Glove4513f6b9-ceac-415d-a1af-1f7585c5989e2025-11-14WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove90058ba8-e55d-4318-9fc5-8f0d25dfdd992025-11-14WarningsExact identifier
KONIX Alcohol Antiseptic Hand RubKONIX ALCOHOL ANTISEPTIC HAND RUBTURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS17435b35-815b-4292-a809-e533ea137b802025-01-29WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove074a760f-9031-40c1-9867-95ef0345418d2025-01-08WarningsExact identifier
MistALCOHOLDerma Glove2a0bcc4e-5114-4afc-91cb-cb4816a63db22024-10-09WarningsExact identifier
HandLOTIONDerma Gloveba9611a3-e2a4-4835-9ffe-aafe85a7cb9c2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove45d130c9-0835-45bb-b525-86a2119c87d12024-10-09WarningsExact identifier
MistALCOHOLDerma Gloveb5bfd7f0-0f96-459e-84d4-24b2081ae46f2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glovee2f89d56-5624-4a94-8151-1edb508232ac2024-10-09WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove06f74478-57aa-4b8d-b888-55e1ee4fbd452024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Gloved3926f48-3a42-42df-a850-47b3914ba3b62024-10-09WarningsExact identifier
MistALCOHOLDerma Glove7c21ee1c-ce2a-464b-8269-cdb3e59db0942024-10-09WarningsExact identifier
HandLOTIONDerma Glovebcd71f37-63aa-4ad9-a9be-e5519c7e66e72024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Gloveffdfb167-0efa-4cd8-afdf-e1ff69ee62522024-10-09WarningsExact identifier
MistALCOHOLDerma Glove11c2939c-e77a-48f6-949c-9d508714012b2024-10-09WarningsExact identifier
Hand RecoveryALCOHOLDerma Glovee6cfe092-cb2c-441b-8897-98626c43bef82024-10-09WarningsExact identifier
HandLOTIONDerma Glove642cc56f-9f39-46be-bbd8-a2346a0efac42024-10-09WarningsExact identifier
HandLOTIONDerma Glove93736944-7535-4035-93aa-4771138af8e32024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove39867f66-b641-4060-881d-161c2591d19c2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove767cc1f2-89a2-4d0b-ae49-ad7b9afca18b2024-10-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

For external use only. Flammable. Keep away from children.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77838-116-152023-01-30C16284748780-1f386c649-aeb4-0266-e053-dadaa90a7c1aHand Sanitizer and Rubbing Alcohol
77838-116-162023-01-30C16284748780-1f386c649-aeb4-0266-e053-dadaa90a7c1aHand Sanitizer and Rubbing Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77838-116-15Prosanca500 mL in 1 BOTTLESPRAY5005
77838-116-16Prosanca1000 mL in 1 BOTTLESPRAY10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77838-116PROSANCA (ETHYL 70% ALOE VERA) GEL PROSANCA (ETHANOL ALCOHOL) GEL PROSANCA (ISOPROPYL 70% ISOPROPYL) SPRAY PROSANCA (ISOPROPYL 91% ISOPROPYL) SPRAY PROSANCA (ETHANOL 91% ETHANOL APPLICATOR) SPRAY PROSANCA (70% ETHANOL) SPRAY PROSANCA (ISOPROPYL 99% ISOPROPYL) SPRAY [PROEM GROUP]5Legacy NDC, 2 package rows20211222_a67e56ed-ac51-6446-e053-2995a90ac063.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa67e56ed-ac51-6446-e053-2995a90ac0635
1041849ethanol 70 % Topical SprayPSNa67e56ed-ac51-6446-e053-2995a90ac0635
2473848ethanol 91 % Topical SprayPSNa67e56ed-ac51-6446-e053-2995a90ac0635
581662ethanol 0.7 ML/ML Topical GelSCDa67e56ed-ac51-6446-e053-2995a90ac0635
1041849ethanol 0.7 ML/ML Topical SpraySCDa67e56ed-ac51-6446-e053-2995a90ac0635
2473848ethanol 0.91 ML/ML Topical SpraySCDa67e56ed-ac51-6446-e053-2995a90ac0635
581662ethanol 70 % Topical GelSYa67e56ed-ac51-6446-e053-2995a90ac0635
1041849ethanol 70 % Topical SpraySYa67e56ed-ac51-6446-e053-2995a90ac0635
2473848ethanol 91 % Topical SpraySYa67e56ed-ac51-6446-e053-2995a90ac0635
581662ethyl alcohol 70 % Topical GelSYa67e56ed-ac51-6446-e053-2995a90ac0635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77838-116-1577838011615500 mL in 1 BOTTLE (77838-116-15) 500 ml2021-01-150000-00-00NoNoCurrent
77838-116-16778380116161000 mL in 1 BOTTLE (77838-116-16) 1000 ml2021-01-150000-00-00NoNoCurrent