Home NDC 10258-101 OXYGENETIX OXYGENATING FOUNDATION
Product NDC 10258-101
11-digit product format 102580101
Labeler code 10258
Product ID 10258-101_0c53ca57-ce37-43ca-85b9-aca04e322d9f
Type HUMAN OTC DRUG
Nonproprietary name SALICYLIC ACID
Dosage form LOTION
Route TOPICAL
Labeler COLONIAL DAMES CO LTD
Application part333D
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-12-21
Marketing end 0000-00-00
Substance SALICYLIC ACID
Active strength 2 g/100mL
NDC exclude flag No
Listing certified through 2020-12-31
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 · 8 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 10258-101-11 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 10258-101-11 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 10258-101-11 I Inactivated by FDA bd6a592717d7…303034d00443…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 10258-101-11 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10258-101-11 OXYGENETIX OXYGENATING FOUNDATIONACNE CONTROL 15 mL in 1 BOTTLE LOTION 15 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10258-101 OXYGENETIX OXYGENATING FOUNDATION ACNE CONTROL (SALICYLIC ACID) LOTION [COLONIAL DAMES CO LTD] 7 Legacy NDC, 1 package rows 20231219_f1126359-649b-4f68-ae46-9a78975dadac.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 10258-101-11 10258010111 15 mL in 1 BOTTLE (10258-101-11) 15 ml 2014-12-21 0000-00-00 No No Current