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 33 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Natural Cherry Honey Herb Throat Drops MENTHOL Ricola Ag 229a7feb-c646-4557-85e5-0832682ab926 2024-12-05 Warnings Exact identifier application number: M022 NATURAL LEMON MINT HERB THROAT DROPS MENTHOL Ricola Ag 0e135eb0-4a40-4930-ade4-fb7df87db1f4 2024-12-05 Warnings Exact identifier application number: M022 Cherry Throat Drops MENTHOL Ricola Ag 73d767e2-bb80-4eff-8420-500c2a4067aa 2024-12-05 Warnings Exact identifier application number: M022 COOL RELIEF ORAL ANESTHETIC MENTHOL Ricola Ag 951e9836-e6a3-4094-8a6b-f226c85c897a 2024-12-05 Warnings Exact identifier application number: M022 COOL RELIEF LEMON FROST ORAL ANESTHETIC MENTHOL Ricola Ag 908f5ce5-94a4-4c35-ae7a-b308ea37fa08 2024-12-05 Warnings Exact identifier application number: M022 ORGANIC PEPPERMINT HERB THROAT DROPS MENTHOL Ricola Ag a6657ecf-e74a-4912-a68c-73abc456f9e2 2024-12-05 Warnings Exact identifier application number: M022 NATURAL LEMON MINT HERB THROAT DROPS MENTHOL Ricola Ag 67373cf1-e8c3-4db2-98e1-c88d25a76209 2024-12-05 Warnings Exact identifier application number: M022 Natural Cherry Honey Herb Throat Drops MENTHOL Ricola Ag 586b2a46-2673-4f27-a62a-2d48a9b520ab 2024-12-05 Warnings Exact identifier application number: M022 BERRY MEDLEY THROAT DROPS MENTHOL Ricola Ag a2bdd035-4678-4cff-b24f-8e2f06acad96 2024-12-05 Warnings Exact identifier application number: M022 Orajel Toothache Rinse BENZYL ALCOHOL, ZINC CHLORIDE Church & Dwight Co., Inc. 41709710-5392-3119-e054-00144ff88e88 2024-11-27 Warnings Exact identifier application number: M022 Orajel Antiseptic Alcohol-Free Mouth Sore Rinse HYDROGEN PEROXIDE, MENTHOL Church & Dwight Co., Inc. 99d47d6a-fa2e-d5ee-e053-2995a90aa11d 2024-11-27 Warnings Exact identifier application number: M022 Orajel 2x Gum Pain Alcohol-Free MENTHOL AND HYDROGEN PEROXIDE Church & Dwight Co., Inc. adf37010-922c-4441-93d6-1e1a95025e90 2024-11-27 Warnings Exact identifier application number: M022 Maximum Strength Cold Sore Treatment CAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUM Meijer Distribution Inc 9220772c-b3b7-4855-e053-2a95a90a94f6 2024-11-27 Warnings Exact identifier application number: M022 Peroxyl Mouth Sore Mild Mint HYDROGEN PEROXIDE Colgate Oral Pharmaceuticals Inc. b1e1b7c9-dea7-4d64-b6a8-5343f4176359 2024-11-25 Warnings Exact identifier application number: M022 NICE SORE THROAT Spearmint PHENOL Leosons Overseas Corp 5fc68f04-ec15-11c0-e053-2a91aa0a1952 2024-11-20 Warnings Exact identifier application number: M022 TANAC Oral Pain Reliever BENZOCAINE Leosons Overseas Corp 81cc61fa-31a7-2214-e053-2a91aa0ae46a 2024-11-15 Warnings Exact identifier application number: M022 NICE SORE THROAT Honey Lemon PHENOL Leosons Overseas Corp 601aea98-e6ab-de6f-e053-2a91aa0a824a 2024-11-15 Warnings Exact identifier application number: M022 NICE SORE THROAT Cherry PHENOL Leosons Overseas Corp 5f21694c-d1c9-0e64-e053-2a91aa0a0ff0 2024-11-15 Warnings Exact identifier application number: M022 Sore Throat PHENOL Safeway, Inc. f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d 2024-11-14 Warnings Exact identifier application number: M022 Sore Throat Relief Cherry PHENOL Best Choice (Valu Merchandisers Company) c0a47d59-3e15-453d-97a7-d626e8650862 2024-11-14 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