Home NDC 53145-004 Aseptil Rojo
Product NDC 53145-004
11-digit product format 531450004
Labeler code 53145
Product ID 53145-004_3a88920c-eeb8-7d71-e063-6294a90ac4af
Type HUMAN OTC DRUG
Nonproprietary name Phenol
Dosage form SPRAY
Route TOPICAL
Labeler Menper Distributors, Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-02-21
Substance PHENOL
Active strength 1.4 mg/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 · 6 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 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 53145-004-01 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 53145-004-01 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 53145-004-01 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 Aseptil Rojo
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENOL 1.4 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 339NCG44TV Internal UNII 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 53145-004-01 Aseptil Rojo 1 in 1 CARTON SPRAY 1 6 53145-004-01 Aseptil Rojo 30 mL in 1 BOTTLE, SPRAY SPRAY 30 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Phenol ACTIVE INGREDIENT 339NCG44TV ASEPTIL ROJO (PHENOL) LIQUID [MENPER DISTRIBUTORS, INC.] 1 PHENOL ACTIVE MOIETY 339NCG44TV ASEPTIL ROJO (PHENOL) LIQUID [MENPER DISTRIBUTORS, INC.] 1 CITRIC ACID ACETATE INACTIVE INGREDIENT DSO12WL7AU ASEPTIL ROJO (PHENOL) LIQUID [MENPER DISTRIBUTORS, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ASEPTIL ROJO (PHENOL) LIQUID [MENPER DISTRIBUTORS, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ASEPTIL ROJO (PHENOL) LIQUID [MENPER DISTRIBUTORS, INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ASEPTIL ROJO (PHENOL) LIQUID [MENPER DISTRIBUTORS, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ASEPTIL ROJO (PHENOL) LIQUID [MENPER DISTRIBUTORS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ASEPTIL ROJO (PHENOL) LIQUID [MENPER DISTRIBUTORS, INC.] 1
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 9 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53145-004-01 53145000401 1 BOTTLE, SPRAY in 1 CARTON (53145-004-01) / 30 mL in 1 BOTTLE, SPRAY 2012-02-21 0000-00-00 No No Current