FDA.reportPublic FDA data

PREMIER PURE Protection

Product NDC
73945-004
Requested package NDC
73945-004-04
11-digit product format
739450004
Labeler code
73945
Product ID
73945-004_8f25edb6-72e1-4884-9687-f1fc00f02667
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
RPP PRODUCTS, INC.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-10
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
72 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage73945-00473945-004-04IInactivated by FDA2026-10-05

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
73945-004-013c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-023c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-033c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-043c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-053c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-063c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-073c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-083c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-093c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-103c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-113c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-123c11775e-0032-45ef-982c-1d3b78b00f46

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73945-004-01PREMIER PURE Protection59 mL in 1 BOTTLE, PLASTICGEL591
73945-004-02PREMIER PURE Protection88.72 mL in 1 BOTTLE, PLASTICGEL88.721
73945-004-03PREMIER PURE Protection118.3 mL in 1 BOTTLE, PLASTICGEL118.31
73945-004-04PREMIER PURE Protection236.59 mL in 1 BOTTLE, PLASTICGEL236.591
73945-004-05PREMIER PURE Protection295.74 mL in 1 BOTTLE, PLASTICGEL295.741
73945-004-06PREMIER PURE Protection354.88 mL in 1 BOTTLE, PLASTICGEL354.881
73945-004-07PREMIER PURE Protection443.17 mL in 1 BOTTLE, PLASTICGEL443.171
73945-004-08PREMIER PURE Protection946 mL in 1 BOTTLE, PLASTICGEL9461
73945-004-09PREMIER PURE Protection1890 mL in 1 BOTTLE, PLASTICGEL18901
73945-004-10PREMIER PURE Protection2000 mL in 1 BOTTLE, PLASTICGEL20001
73945-004-11PREMIER PURE Protection2800 mL in 1 BOTTLE, PLASTICGEL28001
73945-004-12PREMIER PURE Protection3780 mL in 1 BOTTLE, PLASTICGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73945-004PREMIER PURE PROTECTION (ETHYL ALCOHOL) GEL [RPP PRODUCTS, INC.]1Legacy NDC, 12 package rows20200507_3c11775e-0032-45ef-982c-1d3b78b00f46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2277550ethanol 72 % Topical GelPSN3c11775e-0032-45ef-982c-1d3b78b00f461
2277550ethanol 0.72 ML/ML Topical GelSCD3c11775e-0032-45ef-982c-1d3b78b00f461
2277550ethanol 72 % Topical GelSY3c11775e-0032-45ef-982c-1d3b78b00f461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73945-004-0473945000404236.59 mL in 1 BOTTLE, PLASTIC (73945-004-04) 236.59 ml2020-04-100000-00-00NoNoCurrent