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 13 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
S.T.37	HEXYLRESORCINOL	NUMARK BRANDS, INC	7d7acca2-aa8a-5272-e813-faab039cc798	2025-12-15	Warnings	Exact identifier application number: M022
Esunix Oral Bacteriostatic Gel	CETYLPYRIDINIUM CHLORIDE	Xiling (Zhenjiang) Medical Technology Co., Ltd.	3f4ee467-8142-8cb7-e063-6394a90aa7f7	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 4X Medicated For Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	999851ac-925c-7d1f-e053-2a95a90a240b	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 3X Medicated For Toothache and Gum	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	99a2b061-0875-59a4-e053-2995a90ab373	2025-12-12	Warnings	Exact identifier application number: M022
Orajel Antiseptic Rinse For All Mouth Sores	HYDROGEN PEROXIDE AND MENTHOL	Church & Dwight Co., Inc.	06188d36-0d60-6ae6-e054-00144ff8d46c	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 3X Medicated For All Mouth Sores	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	99b589ac-9833-fb60-e053-2995a90a0935	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 4X Medicated For Toothache and Gum, Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	999aa7b9-bf9e-9285-e053-2a95a90a345b	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 4X Medicated PM For Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	999cff2b-c23e-5abe-e053-2a95a90a7569	2025-12-12	Warnings	Exact identifier application number: M022
Benzoin Compound Tincture	BENZOIN RESIN	Humco Holding Group, Inc.	a893a232-2ea8-4e0d-8cbf-7f5040b3be2e	2025-12-11	Warnings	Exact identifier application number: M022
Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	456d45e8-bf6d-31c4-e063-6394a90a5c00	2025-12-10	Warnings	Exact identifier application number: M022
Oral pain relief	BENZOCAINE	ALAINA HEALTHCARE PRIVATE LIMITED	d98c1b2f-fe75-4d52-b082-1abb7628c59e	2025-12-09	Warnings	Exact identifier application number: M022
HEB Sensitive Extra Whitening Twin	SODIUM FLUORIDE	HEB	41d5ae3e-51c1-263b-e063-6394a90a3312	2025-12-08	Warnings	Exact identifier application number: M022
CankerMelts	BENZOCAINE	Quest Products, LLC	070dae82-14c2-66d2-e063-6394a90ab259	2025-12-04	Warnings	Exact identifier application number: M022
Sore Throat ReadyInCase	PHENOL	P & L Development, LLC	2fb3d17e-8ca3-4edb-8b82-4b484f42616e	2025-12-03	Warnings	Exact identifier application number: M022
Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	44f2b66a-26ae-1044-e063-6394a90a9ab6	2025-12-02	Warnings	Exact identifier application number: M022
Sensodyne Fresh Clean	STANNOUS FLUORIDE	Haleon US Holdings LLC	2d433ac1-3ddf-a2f4-e063-6394a90a91f8	2025-12-01	Warnings	Exact identifier application number: M022
Walgreens Saline	NASAL	WALGREEN COMPANY	147e45c8-1e71-4c06-89f1-42e9f9683366	2025-12-01	Warnings	Exact identifier application number: M022
EELHOE Probiotic Bright White Fresh	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	425cec0e-aa74-5341-e063-6294a90ac86b	2025-11-27	Warnings	Exact identifier application number: M022
EELHOE 5 Days Tooth Powder	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	42f98b14-d1d5-4af8-e063-6294a90a8f67	2025-11-27	Warnings	Exact identifier application number: M022
JAYSUING Colour Corrector	GLYCERIN	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	425d9c23-a692-3c62-e063-6294a90a9404	2025-11-27	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