cherry throat relief lozenges

Product NDC: 42961-401
11-digit product format: 429610401
Labeler code: 42961
Product ID: 42961-401_456219da-93a0-f94f-e063-6294a90aee62
Type: HUMAN OTC DRUG
Nonproprietary name: benzocaine
Dosage form: LOZENGE
Route: ORAL
Labeler: Cintas Corporation
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-02-27
Substance: MENTHOL; BENZOCAINE
Active strength: 3.6; 15 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: 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 · 18 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42961-401-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42961-401-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42961-401-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42961-401-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42961-401-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42961-401-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42961-401-18	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42961-401-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42961-401-18	`0efc9e666f02…`	`f202fb6c5f17…`

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: cherry throat relief lozenges
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
U3RSY48JW5	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
49b25e9e-1d47-4a10-e054-00144ff8d46c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42961-401-18	cherry throat relief lozenges	18 in 1 BLISTER PACK	LOZENGE	18		10

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 170 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	af5053d8-ba02-4cdf-877f-8c1e368dafe0	2024-01-10	Warnings	Exact identifier application number: M012
HISTEX	TRIPROLIDINE HYDROCHLORIDE	Allegis Pharmaceuticals, LLC	cc466d33-cf3e-4f1c-a794-6d3d79903adf	2024-01-08	Warnings	Exact identifier application number: M012
HISTEX-DM	DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Allegis Pharmaceuticals, LLC	836d062c-29f0-4fd7-b65c-771a3bbd52c4	2024-01-08	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	A-S Medication Solutions	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	2024-01-08	Warnings	Exact identifier application number: M012
AXIM DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	VIVUNT PHARMA LLC	0e7424ea-461f-5ead-e063-6294a90a41b6	2024-01-05	Warnings	Exact identifier application number: M012
AXIM Night Time - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	0e740063-80d5-c48b-e063-6394a90a3b30	2024-01-05	Warnings	Exact identifier application number: M012
AXIM DayTime - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	0e742e10-daea-6443-e063-6294a90ab5af	2024-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	2024-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	A-S Medication Solutions	fa12a5a8-bf2d-4991-9d54-9c519e8e04cd	2024-01-04	Warnings	Exact identifier application number: M012
NASAL DECONGESTANT PE 10mg	PHENYLPHRINE HCL	YYBA CORP	05824fc4-ef3f-4ebb-b601-252f76ad60ef	2024-01-03	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Proficient Rx LP	5943d975-77e4-4cbd-b2d9-d699052fe82a	2024-01-01	Warnings	Exact identifier application number: M012
Coricidin HBP Cold and Flu	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	Proficient Rx LP	ac79a7dd-c26e-47d2-8fb9-768d2d09e507	2024-01-01	Warnings	Exact identifier application number: M012
Oxymethazoline HCL	OXYMETHAZOLINE HCL	Proficient Rx LP	96883e5f-18b5-4c1c-b984-756cb86be6ff	2024-01-01	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Proficient Rx LP	6e91b9c3-57e8-488b-ac70-d863cdf9d6e8	2024-01-01	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Proficient Rx LP	9e067482-8735-4476-a82e-438dd24d4289	2024-01-01	Warnings	Exact identifier application number: M012
XL-3 Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	AptaPharma Inc.	94e02be4-b8a6-422a-8f66-e6a69e924b2c	2023-12-30	Warnings	Exact identifier application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE	AptaPharma Inc.	8a4c55d0-c472-4e89-9fdb-17ecf0af4856	2023-12-30	Warnings	Exact identifier application number: M012
XL-3 Xtreme	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	AptaPharma Inc.	dff79e0b-edf0-4dd3-a722-fd9beecd6293	2023-12-30	Warnings	Exact identifier application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Salado Sales, Inc.	e25727d0-7dd7-4ef5-b064-7938679f075f	2023-12-29	Warnings	Exact identifier application number: M012
Maximum Strength DM MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	H E B	bb56d09d-ecb0-469e-a16f-f9f1a48942a8	2023-12-29	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	49b25e9e-1d47-4a10-e054-00144ff8d46c	10
824574	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge	SCD	49b25e9e-1d47-4a10-e054-00144ff8d46c	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42961-401-18	42961040118	18 LOZENGE in 1 BLISTER PACK (42961-401-18)	18 lozenge	2015-02-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benzocaine 15 mg Menthol 3.6 mg	Cintas Corporation \| Bestco Inc.	2025-12-07	HUMAN OTC DRUG LABEL	10