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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
62c96dc1-4698-43c1-8e6d-f4062dc5eea2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53145-004-01	2023-07-28	C162847	48780-1	9d75b9d0-30d6-f424-e053-dadaa90a57ce	Aseptil Rojo
53145-004-01	2021-04-21	C162847	48780-1	9d75b9d0-30d6-f424-e053-dadaa90a57ce	Aseptil Rojo
53145-004-01	2020-01-31	C162847	48780-1	9d75b9d0-30d6-f424-e053-dadaa90a57ce	Aseptil Rojo

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
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 35 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chloraspetic	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	2b1808b2-2574-4ab8-a762-5733251848ce	2024-10-25	Warnings	Exact identifier application number: M022
Chloraseptic Warming Sore Throat	PHENOL	Prestige Brands Holdings, Inc.	a197fab2-70ce-4a6c-9add-29d7368a75c5	2024-10-25	Warnings	Exact identifier application number: M022
Gly-Oxide	CARBAMIDE PEROXIDE	Medtech Products Inc.	086a0b82-e947-41c9-89e7-ba06483960c9	2024-10-25	Warnings	Exact identifier application number: M022
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	d500f423-b9f2-4d98-8f2a-8bab7c05737c	2024-10-25	Warnings	Exact identifier application number: M022
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	b30e4b32-89dd-4e53-81d5-1415105361d4	2024-10-25	Warnings	Exact identifier application number: M022
Finafta MultiOral	BENZOCAINE	Efficient Laboratories Inc.	28c5a993-fb5f-4091-af15-32ccae4b9a7d	2024-10-14	Warnings	Exact identifier application number: M022
Rexall Sensitive Freshmint	POTASSIUM NITRATE, SODIUM FLUORIDE	Old East Main CO.	7e715bb9-666e-4de4-ba70-1c84f5243443	2024-10-14	Warnings	Exact identifier application number: M022
Rexall Sensitive Extra Whitening	POTASSIUM NITRATE, SODIUM FLUORIDE	Old East Main CO.	2daf18a3-f71e-4585-8128-4663eff7eb6d	2024-10-14	Warnings	Exact identifier application number: M022
Anadent Kanka Gel	BENZOCAINE	BELMORA LLC	e0f73d78-5db1-43b4-8f58-e5410ca4560f	2024-10-04	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Navajo Manufacturing Company Inc.	f5f26e2f-8a1f-4687-e053-2a95a90ae378	2024-10-03	Warnings	Exact identifier application number: M022
Colgate Great Regular Flavor	SODIUM MONOFLUOROPHOSPHATE	Navajo Manufacturing Company Inc.	f89bf259-b738-8229-e053-6394a90a0c59	2024-10-03	Warnings	Exact identifier application number: M022
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Navajo Manufacturing Company Inc.	f71c53e0-e2dd-16f9-e053-6394a90accff	2024-10-03	Warnings	Exact identifier application number: M022
Crest Pro Health	CETYLPYRIDINIUM CHLORIDE	Navajo Manufacturing Company Inc.	65bf17a9-21ad-27cb-e053-2991aa0afc40	2024-10-02	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Gentle Whitening Advanced	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	94e07979-943b-45bb-8e2b-90d686f3692e	2024-09-04	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Gentle Whitening Advanced Plus	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	6eb304dd-2a24-4fa0-9d39-71264e88dd16	2024-08-29	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Clinical Enamel Strength Deep Clean	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	cfda7efa-86fa-470d-a79f-81907e31778a	2024-08-14	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Kids Bubble Twist	SODIUM FLUORIDE	Haleon US Holdings LLC	e403529a-0fac-4dab-b75c-46906add096b	2024-08-13	Warnings	Exact identifier application number: M022
Calcium Carbonate Assorted Flavors	ANTACID TABLETS	NuCare Pharmaceuticals,Inc.	af10dfb6-fef3-3410-e053-2995a90a9130	2024-07-17	Warnings	Exact identifier application number: M022
SENSODYNE Advanced Whitening Plus	POTASSIUM NITRATE	Haleon US Holdings LLC	f757ccdd-b316-4799-a34a-10edbb73da6b	2024-07-12	Warnings	Exact identifier application number: M022
dentalux SENSITIVE ANTI-CAVITY FLUORIDE	POTASSIUM NITRATE, SODIUM FLUORIDE	Lidl US, LLC	baef7f15-8082-4e61-8c08-8beda8ad40c0	2024-07-03	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
339NCG44TV	PHENOL	108-95-2	PHENOL

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