Home NDC 57915-020-01 germstarONE
Product NDC 57915-020
Requested package NDC 57915-020-01
11-digit product format 579150020
Labeler code 57915
Product ID 57915-020_29a4cfde-1821-e664-e063-6394a90a9d87
Type HUMAN OTC DRUG
Nonproprietary name Ethyl Alcohol
Dosage form SOLUTION
Route TOPICAL
Labeler Soaptronic, LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-04-30
Substance ALCOHOL
Active strength 630 g/1000g
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 germstarONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 630 g/1000g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3K9958V90M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1041807 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57915-020-01 germstarONE 946 g in 1 BAG SOLUTION 946 17 57915-020-02 germstarONE 474 g in 1 BOTTLE, PUMP SOLUTION 474 17 57915-020-04 germstarONE 59 g in 1 BOTTLE, SPRAY SOLUTION 59 17 57915-020-05 germstarONE 3785 g in 1 BOTTLE SOLUTION 3785 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57915-020 GERMSTARONE (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC] 17 Current NDC, Legacy NDC, 4 package rows 20241225_a6909a0f-de15-51e3-e053-2995a90ab34f.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 9 of 115 · 2,286 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57915-020-01 57915002001 946 g in 1 BAG (57915-020-01) 946 g 2020-05-12 0000-00-00 No No Current