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 8 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Meijer, Inc.	c9c17224-9304-403a-b6a1-9c8bd94e3d94	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M022
AQUAFRESH CAVITY PROTECTION	SODIUM FLUORIDE	Haleon US Holdings LLC	5484999c-8e6f-430d-99a5-6893a2489467	2026-02-16	Warnings	Exact identifier application number: M022
AQUAFRESH EXTREME CLEAN WHITENING ACTION	SODIUM FLUORIDE	Haleon US Holdings LLC	aaff19d9-4ba5-462a-893b-7220feb25d6c	2026-02-16	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	Walgreen Co.	55807b18-42ed-45a7-845e-fcf7f5d70d04	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: m022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Walgreen Co.	33223589-4ff4-4e4e-96da-6fa2e4d0f187	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M022
PERIOSCIENCES SENSITIVE AO Pro	POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE	PERIOSCIENCES LLC	acca8964-b575-468c-8b40-514dfbf50778	2026-02-09	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	Retail Business Services, LLC	d46546d0-c6df-431a-8ab0-bc5013c084d7	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	e19228e9-6f87-456e-a222-f979a234d589	2026-02-06	Warnings	Exact identifier application number: M022
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	49d28991-b68f-ba16-e063-6394a90a0b13	2026-02-02	Warnings	Exact identifier application number: M022
Sootheez Strawberry Lemonade	PECTIN	Primrose Candy Co.	49e2b303-1018-cd13-e063-6394a90ae300	2026-02-02	Warnings	Exact identifier application number: M022
Sootheez Berry Lemonade	PECTIN	Primrose Candy Co.	49cee56f-c45f-6c79-e063-6294a90a5f8f	2026-02-01	Warnings	Exact identifier application number: M022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Rite Aid Corporation	294418aa-640d-42be-ad07-de31da7a7ccc	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain Reliever	MEDICATED TOOTH AND GUM PAIN RELIEVER	Kungpo Health Care & Herbal Center Inc	aa61ce6f-8336-4071-93b8-549fd22d1ae0	2026-01-22	Warnings	Exact identifier application number: M022
Colgate Sensitive Complete Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	866067b9-3dce-492d-ae99-1b807ecd56ff	2026-01-22	Warnings	Exact identifier application number: M022
Family Wellness Pain Relief	BENZOCAINE 20%	FAMILY DOLLAR (Family Wellness)	92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea	2026-01-21	Warnings	Exact identifier application number: M022
Crest Pro-Health All Day Clean Breath	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	48eaca4c-19c2-2dd2-e063-6394a90a3e08	2026-01-21	Warnings	Exact identifier application number: M022
Betadine Gargle	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	5f0a3377-1398-2603-c632-f0d214bb88ec	2026-01-21	Warnings	Exact identifier application number: M022
ORAL PAIN RELIEF	BENZOCAINE	Universal Distribution Center LLC	e276ba37-46fb-4ed9-9ee1-c08a2a89704a	2026-01-20	Warnings	Exact identifier application number: M022
Equate Orasol	20% BENZOCAINE	WAL-MART STORES INC.	08404780-8252-4484-b1c3-8970803f74f8	2026-01-19	Warnings	Exact identifier application number: M022
Equate Healthy Mouth	CPC 0.05% ANTIPLAQUE/ANTI-GINGIVITIS	Walmart, Inc.	1cc1f6fd-67d4-b314-e063-6294a90ab995	2026-01-19	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