FDA.reportPublic FDA data

MEDI-FIRST First Aid Antiseptic

Product NDC
78495-102
Requested package NDC
78495-102-01
11-digit product format
784950102
Labeler code
78495
Product ID
78495-102_3239abbd-8034-7f52-e063-6294a90a8740
Type
HUMAN OTC DRUG
Nonproprietary name
ISOPROPYL ALCOHOL
Dosage form
SPRAY
Route
TOPICAL
Labeler
Ultra Distributors Inc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-19
Substance
ISOPROPYL ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
MEDI-FIRST First Aid Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL70 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014638Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6c88941-9982-3a37-e053-2995a90a8a5aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78495-102-012025-04-07C16284748780-12cef2736-597d-d83d-e063-dadaa90ab31f78495-102
78495-102-012025-01-30C16284748780-12cef2736-597d-d83d-e063-dadaa90ab31f78495-102

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78495-102-01MEDI-FIRST First Aid Antiseptic59.1 mL in 1 BOTTLE, PUMPSPRAY59.12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78495-102MEDI-FIRST FIRST AID ANTISEPTIC (ISOPROPYL ALCOHOL) SPRAY [ULTRA DISTRIBUTORS INC]2Current NDC, Legacy NDC, 1 package rows20250409_b6c88941-9982-3a37-e053-2995a90a8a5a.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 49 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLCVS PHARMACY, INC4f628fbd-e213-43ac-9699-d678331f37652025-12-17WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLDynarex Corporation39b20f1b-8d2f-4fa0-8cb9-10cad408e0642025-12-16WarningsExact identifier
application number: M003
finipil Lait 50BENZETHONIUM CHLORIDEEquibal, Inc.bc630fbc-e428-4d46-8330-fb6f699943fd2025-12-16WarningsExact identifier
application number: M003
PS-2205 BZK Antiseptic TowelettesPS-2205 BZK ANTISEPTIC TOWELETTESProStat First Aid LLC00772636-8265-a937-e063-6294a90a438a2025-12-15WarningsExact identifier
application number: M003
PS-2362 Hand Sanitizer 0.9g packetPS-2362 HAND SANITIZER 0.9G PACKETProStat First Aid LLC01c87dff-57e0-017a-e063-6394a90a16002025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e120fed-3225-520b-e063-6394a90a9f9e2025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProstat First Aid LLC0e241343-db64-3f1c-e063-6394a90ab5382025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESFront Line Safety0e0ca589-834b-495b-e063-6394a90afbd02025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0e0dd88e-62eb-02c8-e063-6394a90a63d82025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProStat First Aid LLC0e21f466-d6ed-79c4-e063-6394a90ae9882025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0dfd48bb-3353-6062-e063-6294a90af6282025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESFront Line Safety0e1f3653-d75e-9c9e-e063-6294a90ab6392025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0e0ef369-a0e7-5320-e063-6394a90a353f2025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e11238b-e5f2-075f-e063-6394a90aa8252025-12-15WarningsExact identifier
application number: M003
3% HYDROGEN PEROXIDEHYDROGEN PEROXIDEUniversal Distribution Center LLC53573a9c-bddc-49ea-931e-4779a20eb14f2025-12-15WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab4b75-7a52-46b1-e063-6294a90a72532025-12-14WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab2ced-cc6f-2c20-e063-6294a90a36d92025-12-14WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDE4 Visions LLC45c3c6da-5217-5c2b-e063-6294a90a56d32025-12-12WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZERALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd1abf5aca-346f-0d18-e063-6294a90a93392025-12-11WarningsExact identifier
application number: M003
DeeyeoDISINFECTING WET WIPESHenan Yeesain Health Technology Co., Ltd.45b33db6-13b4-5e28-e063-6294a90a6ea12025-12-11WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014638isopropyl alcohol 70 % Topical SprayPSNb6c88941-9982-3a37-e053-2995a90a8a5a2
1014638isopropyl alcohol 0.7 ML/ML Topical SpraySCDb6c88941-9982-3a37-e053-2995a90a8a5a2
1014638isopropyl alcohol 70 % Topical SpraySYb6c88941-9982-3a37-e053-2995a90a8a5a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78495-102-017849501020159.1 mL in 1 BOTTLE, PUMP (78495-102-01) 59.1 ml2020-12-190000-00-00NoNoCurrent