Home NDC 61010-5500 Isopropyl Alcohol
Product NDC 61010-5500
11-digit product format 610105500
Labeler code 61010
Product ID 61010-5500_3bdedf7b-d99b-fa9e-e063-6294a90aa631
Type HUMAN OTC DRUG
Nonproprietary name Isopropyl Alcohol
Dosage form SPRAY
Route TOPICAL
Labeler Safetec of America, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-02-16
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 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61010-5500-2 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61010-5500-2 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61010-5500-2 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61010-5500-2 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61010-5500-2 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61010-5500-2 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61010-5500-2 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 61010-5500-2 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 61010-5500-2 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 61010-5500-2 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 61010-5500-2 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 61010-5500-2 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 61010-5500-2 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 61010-5500-2 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 61010-5500-2 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 61010-5500-2 I Inactivated by FDA bd6a592717d7…303034d00443…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 61010-5500-2 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 61010-5500-2 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 61010-5500-2 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Isopropyl Alcohol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOPROPYL ALCOHOL 70 mL/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ND2M416302 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014638 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-5500-2 Isopropyl Alcohol 59.1 mL in 1 BOTTLE, SPRAY SPRAY 59.1 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-5500 ISOPROPYL ALCOHOL SPRAY [SAFETEC OF AMERICA, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20210204_89310a64-c4cc-46c6-8294-c4d28cd88118.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 65 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SHERK SANITIZER GREEN APPLE ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3f03af0d-b1a6-8fd1-e063-6294a90ad091 2025-09-17 Warnings Exact identifier application number: M003 SHERK SANITIZER WATERMELON ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3f03d420-e41f-a923-e063-6294a90ab6d3 2025-09-17 Warnings Exact identifier application number: M003 Hand Sanitizer plus Holder BENZALKONIUM CHLORIDE Gertex Hosiery a182eafa-0ce0-4b99-bcb0-23f9a8de9e1f 2025-09-17 Warnings Exact identifier application number: M003 Booboo Bubbles HYDROGEN PEROXIDE 72 Seasons LLC 3e8b538c-d4d6-7d76-e063-6394a90a96d1 2025-09-15 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Champagne Apple ETHYL ALCOHOL 70% MY IMPORTS USA LLC 3ece368e-1c98-6275-e063-6294a90a1dec 2025-09-14 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Caramel Cinnamon ETHYL ALCOHOL 70% MY IMPORTS USA LLC 3ece74d3-fec4-55cc-e063-6394a90afda9 2025-09-14 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Vanilla Cascade ETHYL ALCOHOL 70% MY IMPORTS USA LLC 3ece4de7-4c1c-5dde-e063-6294a90ae56e 2025-09-14 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Jasmine Shade ETHYL ALCOHOL 70% MY IMPORTS USA LLC 3ecf17c6-3a97-7dc5-e063-6294a90a85c6 2025-09-14 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Dragon Fruit ETHYL ALCOHOL 70% MY IMPORTS USA LLC 3ecf0c05-15f2-cf9e-e063-6294a90ab846 2025-09-14 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Cherry Berry ETHYL ALCOHOL 70% MY IMPORTS USA LLC 3eced383-2f0b-3c0d-e063-6394a90afce4 2025-09-14 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Mango Papaya ETHYL ALCOHOL 70% MY IMPORTS USA LLC 3ecf2280-56e6-4770-e063-6394a90a3e3c 2025-09-14 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Ocean Breeze ETHYL ALCOHOL 70% MY IMPORTS USA LLC 3ecf411b-2748-7296-e063-6394a90a3bec 2025-09-14 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Petal Cascade ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 3ecf4668-3ece-a665-e063-6394a90afe12 2025-09-14 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Salted Caramel ETHYL ALCOHOL 70% MY IMPORTS USA LLC 3ecf534b-c865-1e80-e063-6394a90a245b 2025-09-14 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Salted Caramel ETHYL ALCOHOL 70% Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 3e93d14e-38a1-af85-e063-6394a90af14c 2025-09-12 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Ocean Breeze ETHYL ALCOHOL 70% Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 3e927c78-3295-9484-e063-6294a90a2ed4 2025-09-11 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Petal Cascade ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 3e92fc21-e96c-a6ac-e063-6294a90a8805 2025-09-11 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Cherry Berry ETHYL ALCOHOL 70% Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 3e6c959e-62cf-ec7c-e063-6294a90a0b12 2025-09-10 Warnings Exact identifier application number: M003 Smart Care Kids Hand Sanitizer Transformers ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3e6debb9-8eeb-c82f-e063-6394a90a89f5 2025-09-10 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Barbie ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3e6e665b-78d8-bf9c-e063-6394a90a4acc 2025-09-10 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 61010-5500-2 61010550002 59.1 mL in 1 BOTTLE, SPRAY (61010-5500-2) 59.1 ml 2012-02-16 0000-00-00 No No Current