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 20 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Walgreens Mouth Sore Relief BENZOCAINE Walgreens 253d7ea2-e48e-c7d7-e063-6394a90ae001 2025-08-12 Warnings Exact identifier application number: M022 Charm Tex FLUORIDE Gel SODIUM FLUORIDE Yangzhou Hongshengding Chemical Co.,Ltd. 897b0102-1c96-4699-908e-a7b7e26cd29f 2025-08-08 Warnings Exact identifier application number: M022 Meijer Enamel Guard POTASSIUM NITRATE, SODIUM FLUORIDE Meijer Distribution Inc 82bc95be-0a07-3f00-e053-2a91aa0a7438 2025-08-08 Warnings Exact identifier application number: M022 Topco Associates LLC Maximum Strength FLUORIDE Topco Associates LLC ac398ff0-0010-4e13-8b89-dc986fd7f974 2025-08-08 Warnings Exact identifier application number: M022 QUALITY CHOICE SALINE PLUS SOOTHING ALOE QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) 4ae4e88a-aaa5-4195-bedc-622fd5cd9394 2025-07-30 Warnings Exact identifier application number: M022 Aseptil Rojo PHENOL Menper Distributors, Inc. 62c96dc1-4698-43c1-8e6d-f4062dc5eea2 2025-07-22 Warnings Exact identifier application number: M022 ndc (product): 53145-004 Anestenka BENZOCAINE Menper Distributors, Inc 00a3f1bc-ddfe-47c6-8221-f48f91513503 2025-07-22 Warnings Exact identifier application number: M022 Cureforte Breath Reset MOUTH SPRAY STEEL CITY HEALTH PRIVATE LIMITED 38ddf1a7-29ab-cb8d-e063-6294a90ad34c 2025-07-21 Warnings Exact identifier application number: M022 SprinJene Natural Sensitivity and Gum POTASSIUM NITRATE Health and Natural Beauty USA Corp 3cb23e36-0e8c-4172-b4ae-859b58a2739f 2025-07-07 Warnings Exact identifier application number: M022 Normal Salt SODIUM CHLORIDE Twin Med LLC dc82ff0f-8600-373a-e053-2995a90a7505 2025-07-03 Warnings Exact identifier application number: M022 Sensodyne Pronamel Kids Berry Twist SODIUM FLUORIDE Haleon US Holdings LLC 69c07c36-b5e0-420b-ab29-7d1091386322 2025-07-03 Warnings Exact identifier application number: M022 DenTek Instant Pain Relief Maximum Strength BENZOCAINE DenTek Oral Care, Inc. ae92b76e-815a-4b4c-8128-bd045098caa5 2025-06-30 Warnings Exact identifier application number: M022 Sensodyne Clinical White Stain Protector POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC 99037e59-53d6-492c-8fce-67641fc8efdd 2025-06-25 Warnings Exact identifier application number: M022 Iolite-S BENZOCAINE Dharma Research, Inc. b3b68914-2adc-4f07-9521-0b18756be522 2025-06-14 Warnings Exact identifier application number: M022 Red Cross Toothache EUGENOL The Mentholatum Company 3537e599-65d9-48d6-8a46-d42312f71e84 2025-06-11 Warnings Exact identifier application number: M022 QUALITY CHOICE Sore Throat PHENOL CHAIN DRUG MARKETING ASSOCIATION c95ee086-f384-475d-ad0c-75518cb9d2fe 2025-06-10 Warnings Exact identifier application number: M022 Onral Oral Pain Reliever Mouthwash BENZOCAINE Syka Pharma Inc. 5dd8d933-6f32-4eaf-8eca-9365d7de55a2 2025-06-03 Warnings Exact identifier application number: M022 Orajel Rescue Relief Pen ORAL PAIN RELIEVER Church & Dwight Co., Inc. 2d68eec5-ae8a-9cdf-e063-6294a90a9799 2025-06-01 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 9e1f7462-a052-4db4-bc59-cce437b695d0 2025-05-20 Warnings Exact identifier application number: M022 Saline 1.5 FL OZ SALINE ALAINA HEALTHCARE PRIVATE LIMITED f1bdbb25-6943-4828-9ae0-7d9783c18b5f 2025-05-19 Warnings Exact identifier application number: M022
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