Sore Throat Logenzes

Product NDC: 0904-6255
11-digit product format: 009046255
Labeler code: 0904
Product ID: 0904-6255_4b972e11-08d1-5afd-e063-6294a90a97f1
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine and Menthol
Dosage form: LOZENGE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-12-28
Substance: BENZOCAINE; MENTHOL
Active strength: 15; 3.6 mg/1; mg/1
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0904-6255-49	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0904-6255-49	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0904-6255-49	`bd6a592717d7…`	`303034d00443…`

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: Sore Throat Logenzes
Brand name suffix: Sore Throat
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	15 mg/1
MENTHOL	3.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
824574	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
11416620-4892-44ba-9780-db27efff6743	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0904-6255-49	2023-11-09	C162847	48780-1	d6a99b39-9f14-a426-e053-dadaa90af4c2	Cēpacol ® SORE THROAT
0904-6255-49	2022-01-28	C162847	48780-1	d6a99b39-9f14-a426-e053-dadaa90af4c2	Cēpacol ® SORE THROAT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6255-49	Sore Throat LogenzesSore Throat	18 in 1 BLISTER PACK	LOZENGE	18		5
0904-6255-49	Sore Throat LogenzesSore Throat	18 in 1 CARTON	LOZENGE	18		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6255-49	EA - Each	0904-6255	a2eb59a3-971e-4b7e-9167-67437d055528	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]	1
ALLYL SUCROSE	INACTIVE INGREDIENT	VI3D59RW0U	SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]	1
CORN SYRUP	INACTIVE INGREDIENT	9G5L16BK6N	SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]	1
HYDROGENATED SOYBEAN OIL	INACTIVE INGREDIENT	A2M91M918C	SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6255	SORE THROAT LOGENZES SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [MAJOR PHARMACEUTICALS]	3	Current NDC, Legacy NDC, 2 package rows	20231110_11416620-4892-44ba-9780-db27efff6743.zip

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 26 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	WALMART INC.	321430a5-11c9-4d33-8638-5149f601f1bb	2026-05-22	Warnings	Exact identifier application number: M012
dg health cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Dolgencorp Inc	ddcc1e78-4ea8-4489-88e7-86ff46016464	2026-05-21	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY DAYTIME FLU RELIEF MAX STRENGTH	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	AMERISOURCE BERGEN	45dc9dd7-134a-4e70-a07e-7bfdf0dc1c4e	2026-05-21	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Kenvue Brands LLC	525467fb-510d-0b4b-e063-6294a90acd36	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Reckitt Benckiser LLC	4cee80e5-e412-e832-e063-6394a90aeb90	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Reckitt Benckiser LLC	4a9464cf-0c77-23d0-e063-6394a90a62f1	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens Night Time Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Reckitt Benckiser LLC	4ceda68e-c7ce-eb87-e063-6394a90a8ded	2026-05-21	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	5258ea3f-87f1-7f86-e063-6394a90ab82f	2026-05-21	Warnings	Exact identifier application number: M012
RELIABLE-1 ANTI DRIP PUMP MIST	OXYMETAZOLINE HYDROCHLORIDE	Reliable 1 Laboratories LLC	7df9905d-09aa-4c84-8b6f-6e5ed90df0da	2026-05-21	Warnings	Exact identifier application number: M012
daytime nitetime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Publix Super Markets Inc	80abb6b8-b0d5-4f19-8588-50b8717510bb	2026-05-21	Warnings	Exact identifier application number: M012
FAMILY DOLLAR ULTRA FINE MIST SINUS RELIEF	OXYMETAZOLINE HYDROCHLORIDE	FAMILY DOLLAR SERVICES INC	27163169-54d0-4b6e-94cd-721b29b18249	2026-05-20	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Cough Fast	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5241b11a-72c8-5e67-e063-6394a90a4353	2026-05-20	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	50b140ad-aba2-ce6b-e063-6294a90ae2f8	2026-05-20	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Recharge Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	4bae240c-70ce-e9c2-e063-6394a90a5f3d	2026-05-20	Warnings	Exact identifier application number: M012
Childrens Mucinex Multi Symptom Cold and Childrens Mucinex Night Time Multi Symptom Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	85f7d60b-32ec-4ec2-86ec-f677093bce1d	2026-05-20	Warnings	Exact identifier application number: M012
Chloraseptic Nighttime Sore Throat Hot Relief	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Prestige Brands Holdings, Inc.	9c13c052-a5d1-43d2-8d29-4ea011a971ac	2026-05-20	Warnings	Exact identifier application number: M012
Cold and Flu Severe, Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	a0bff310-2d35-4a18-815b-8386e44730a2	2026-05-19	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	61a1beb3-decf-4c8d-a402-93a02ec40a43	2026-05-19	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	52291746-2bbf-8f3f-e063-6294a90adcfc	2026-05-19	Warnings	Exact identifier application number: M012
MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift Kickstart	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, TRIPROLIDINE HCI	Reckitt Benckiser LLC	fdb70793-5dd1-0455-e053-6394a90ac621	2026-05-19	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
824574	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge	PSN	11416620-4892-44ba-9780-db27efff6743	5
824574	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge	SCD	11416620-4892-44ba-9780-db27efff6743	5
824574	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge	PSN	71a80e13-bda3-40fb-b4e7-45e9985e707c	2
824574	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge	SCD	71a80e13-bda3-40fb-b4e7-45e9985e707c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6255-49	00904625549	18 BLISTER PACK in 1 CARTON (0904-6255-49) / 18 LOZENGE in 1 BLISTER PACK	18 blister pack	2012-12-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cēpacol ® SORE THROAT	Major Pharmaceuticals \| Bestco \| Bestco, Inc.	2026-02-24	HUMAN OTC DRUG LABEL	5
Cēpacol SORE THROAT	ATLANTIC BIOLOGICALS CORP. \| UNIT DOSE SOLUTION	2025-11-24	HUMAN OTC DRUG LABEL	2
SORE THROAT LOGENZES SORE THROAT-	DIRECT RX	2023-07-20	HUMAN OTC DRUG LABEL	4
Cēpacol ® SORE THROAT	REMEDYREPACK INC.	2022-07-12	HUMAN OTC DRUG LABEL	4