Home NDC 78009-110-06 Dermo Real
Product NDC 78009-110
Requested package NDC 78009-110-06
11-digit product format 780090110
Labeler code 78009
Product ID 78009-110_e465a1ce-44d8-4e92-a36c-7688cc3ffc7d
Type HUMAN OTC DRUG
Nonproprietary name Ethyl Alcohol
Dosage form GEL
Route TOPICAL
Labeler Saflosa Industria Real, S.A. de C.V.
Application part333A
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-05-24
Marketing end 0000-00-00
Substance ALCOHOL
Active strength 70 mL/100mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record
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 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78009-110-01 Dermo Real 3785 mL in 1 BOTTLE GEL 3785 1 78009-110-02 Dermo Real 960 mL in 1 BOTTLE, PUMP GEL 960 1 78009-110-03 Dermo Real 960 mL in 1 BOTTLE GEL 960 1 78009-110-06 Dermo Real 30 mL in 1 BOTTLE GEL 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78009-110 DERMO REAL (ETHYL ALCOHOL) GEL [SAFLOSA INDUSTRIA REAL, S.A. DE C.V.] 1 Legacy NDC, 4 package rows 20200529_dc09c55b-3c64-45c3-9e51-34b0b76e8563.zip
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 78009-110-06 78009011006 30 mL in 1 BOTTLE (78009-110-06) 30 ml 2020-05-24 0000-00-00 No No Current