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 104 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nourishing Hand Sanitizer Limon ALCOHOL Noshinku d70fba7a-513f-0341-e053-2a95a90add86 2024-05-15 Warnings Exact identifier application number: M003 Nourishing Hand Sanitizer Vetiver ALCOHOL Noshinku d70fb84c-fdbc-6ba8-e053-2995a90ab529 2024-05-15 Warnings Exact identifier application number: M003 Safly BZK Antiseptic Towelette BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 5cd9043e-daf2-43eb-9568-54775fc4f84a 2024-05-15 Warnings Exact identifier application number: M003 Noshinku Bergamot Hand Sanitizer ALCOHOL Noshinku 53fea81e-4482-6fae-e054-00144ff8d46c 2024-05-14 Warnings Exact identifier application number: M003 Noshinku Eucalyptus Hand Sanitizer ALCOHOL Noshinku 9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c0 2024-05-14 Warnings Exact identifier application number: M003 Noshinku Lavender Hand Sanitizer ALCOHOL Noshinku a57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf 2024-05-14 Warnings Exact identifier application number: M003 LEADER 2% Mild Iodine Tincture IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID Cardinal Health, 110 dba Leader 7f810b92-60f6-2f72-e053-2991aa0ab973 2024-05-13 Warnings Exact identifier application number: M003 Leader Decolorized Iodine ALCOHOL LIQUID Cardinal Health, 110 dba Leader 822f6f28-956f-dd82-e053-2991aa0ae752 2024-05-13 Warnings Exact identifier application number: M003 Inverness Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a2995-334c-2e93-e063-6294a90aecf7 2024-05-09 Warnings Exact identifier application number: M003 Helzberg Diamonds Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a3776-0edd-26f3-e063-6294a90a740d 2024-05-09 Warnings Exact identifier application number: M003 Ulta Beauty Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a37f4-8718-3e40-e063-6294a90acaad 2024-05-09 Warnings Exact identifier application number: M003 Guardian Vaginal BENZALKONIUM CHLORIDE Eastern Century Pharmaceuticals 1605ba44-02b7-4c72-9fec-89a5aa962b44 2024-04-24 Warnings Exact identifier application number: M003 Inverness Hygienic Ear Care Antiseptic BENZALKONIUM CHLORIDE The Richline Group, Inc. 0ccd72e7-16a2-47c7-9ce6-dffb63a0344b 2024-04-18 Warnings Exact identifier application number: M003 Lovisa Piercing Care Solution BENZALKONIUM CHLORIDE The Richline Group, Inc. 74f46b81-cc5b-4e3f-a36e-0bd86d370c22 2024-04-18 Warnings Exact identifier application number: M003 CliniClean BZK Cleansing Contains Benzalkonium Chloride BENZALKONIUM CHLORIDE HR HealthCare b6916466-0931-408f-a430-0797a449c32e 2024-04-18 Warnings Exact identifier application number: M003 Handy Solutions First Aid Kit BENZALKONIUM CHLORIDE Navajo Manufacturing Company Inc. 130237ff-3db4-1288-e063-6394a90ab1af 2024-04-16 Warnings Exact identifier application number: M003 BZK BENZALKONIUM CHLORIDE Henry Schein Inc. ff877b63-fa58-4770-a882-694eda33203b 2024-04-02 Warnings Exact identifier application number: M003 First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE M-star (Hubei) Health&Care Products Co., Ltd. 8e1f35ff-d4e6-4940-ad8f-dce2b73e595d 2024-04-01 Warnings Exact identifier application number: M003 Antiseptic Towelette TOALLITAS ANTISEPTICAS BENZALKONIUM CHLORIDE M-star (Hubei) Health&Care Products Co., Ltd. b267e186-cf7a-458f-9c28-a48a8554af40 2024-04-01 Warnings Exact identifier application number: M003 Antiseptic Povidone Iodine Prep Pad POVIDONE-IODINE M-star (Hubei) Health&Care Products Co., Ltd. fc76c1f3-b48e-4276-890d-5b8e5a894e62 2024-04-01 Warnings Exact identifier application number: M003
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