Home NDC 61010-4111 Instant Hand Sanitizer
Product NDC 61010-4111
11-digit product format 610104111
Labeler code 61010
Product ID 61010-4111_129de921-3817-daaf-e063-6394a90a7b9c
Type HUMAN OTC DRUG
Nonproprietary name alcohol
Dosage form GEL
Route TOPICAL
Labeler Safetec of America, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-12-16
Substance ALCOHOL
Active strength .7 g/mL
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 · 24 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 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 61010-4111-0 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 61010-4111-0 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 product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 61010-4111-1 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 61010-4111-0 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 61010-4111-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 61010-4111-0 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…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 product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 61010-4111-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 61010-4111-0 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 product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 61010-4111-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 61010-4111-0 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 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 61010-4111-0 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 61010-4111-1 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 Instant Hand Sanitizer
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL .7 g/mL
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 581662 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-4111-1 Instant Hand Sanitizer 1026000 mL in 1 CONTAINER GEL 1026000 4 61010-4111-0 Instant Hand Sanitizer 473 mL in 1 BOTTLE, PUMP GEL 473 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded alcohol ACTIVE INGREDIENT 3K9958V90M INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.] 1 alcohol ACTIVE INGREDIENT 3K9958V90M INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA] 1 alcohol ACTIVE MOIETY 3K9958V90M INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.] 1 alcohol ACTIVE MOIETY 3K9958V90M INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA] 1 aloe INACTIVE INGREDIENT V5VD430YW9 INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA] 1 aloe vera leaf INACTIVE INGREDIENT ZY81Z83H0X INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.] 1 carbomer interpolymer type a (55000 mpa.s) INACTIVE INGREDIENT 59TL3WG5CO INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.] 1 d&c green no. 5 INACTIVE INGREDIENT 8J6RDU8L9X INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.] 1 d&c yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.] 1 trolamine INACTIVE INGREDIENT 9O3K93S3TK INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.] 1 trolamine INACTIVE INGREDIENT 9O3K93S3TK INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA] 1 water INACTIVE INGREDIENT 059QF0KO0R INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-4111 INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240302_0f6f2a67-4fed-407e-a2c5-51574a5bbf65.zip 61010-4111 INSTANT HAND SANITIZER (ALCOHOL) GEL [SAFETEC OF AMERICA] 1 Current NDC, Legacy NDC, 1 package rows 20100921_3784c55f-928f-4766-902a-d09ba1ed42ae.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 1 of 1 · 1 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 61010-4111-0 61010411100 473 mL in 1 BOTTLE, PUMP 473 ml Historical 61010-4111-1 61010411101 1026000 mL in 1 CONTAINER (61010-4111-1) 1026000 ml 2010-12-16 0000-00-00 No No Current