Cepacol

Product NDC: 63824-732
11-digit product format: 638240732
Labeler code: 63824
Product ID: 63824-732_51a73861-dad4-e880-e063-6294a90a9190
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine and Menthol
Dosage form: LOZENGE
Route: ORAL
Labeler: Reckitt Benckiser LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-07-15
Substance: BENZOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength: 15; 2.6 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

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: Cepacol
Brand name suffix: Extra Strength Sore Throat honey lemon
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	15 mg/1
MENTHOL, UNSPECIFIED FORM	2.6 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858664	Internal RxNorm lookup
1235472	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
d771095b-7de3-48f3-a125-8bc76e7d1778	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63824-732-16	CepacolExtra Strength Sore Throat honey lemon	8 in 1 BLISTER PACK	LOZENGE	8		12
63824-732-16	CepacolExtra Strength Sore Throat honey lemon	2 in 1 CARTON	LOZENGE	2		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-732-16	EA - Each	63824-732	7758e732-5bdc-4055-a3f5-57cf36bc3e51	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
isomalt	INACTIVE INGREDIENT	S870P55O2W	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
maltitol	INACTIVE INGREDIENT	D65DG142WK	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63824-732	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RB HEALTH (US) LLC]	9	Current NDC, Legacy NDC, 2 package rows	20250330_d771095b-7de3-48f3-a125-8bc76e7d1778.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 9 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Wintergreen Peppermint	POTASSIUM NITRATE, SODIUM FLUORIDE	Twice Twice LLC	7b7beec2-e070-4102-a2a4-68c332fc9fb3	2026-01-19	Warnings	Exact identifier application number: M022
GuruNanda Sensitive	POTASSIUM NITRATE	GURUNANDA, LLC	3ef0d3d4-fd42-0181-e063-6394a90af09c	2026-01-19	Warnings	Exact identifier application number: M022
Up and Up Antiseptic	CETYLPYRIDINIUM CHLORIDE	Target Corporation	386ee9f9-598e-ad00-e063-6394a90aeb46	2026-01-19	Warnings	Exact identifier application number: M022
Colgate Sensitive Complete Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	4a8f1d2f-b326-46d2-8914-d65ccc409edf	2026-01-18	Warnings	Exact identifier application number: M022
Colgate Sensitive Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	3b656928-af58-4ee9-8fb8-360688eb9bf3	2026-01-13	Warnings	Exact identifier application number: M022
Colgate Sensitive Enamel Health	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	a50d4259-8a79-417e-b381-72c7a8ec0418	2026-01-13	Warnings	Exact identifier application number: M022
Walgreens Sensitive Enamel Repair	SODIUM FLUORIDE	Walgreens	41d6384d-695b-b60b-e063-6394a90aa0b9	2026-01-09	Warnings	Exact identifier application number: M022
HyVee Throat Drops Lemon Mint	MENTHOL	HY-VEE, INC	47f738cc-7968-cc07-e063-6294a90af7ab	2026-01-09	Warnings	Exact identifier application number: M022
CVS Health Clinical White Stain Protector	SODIUM FLUORIDE	CVS Pharmacy	41d5c3a9-abe5-5528-e063-6294a90ada79	2026-01-09	Warnings	Exact identifier application number: M022
CVS Health Sensitive Enamel Repair	SODIUM FLUORIDE	CVS	41d547b3-2feb-8e83-e063-6294a90ae3cd	2026-01-09	Warnings	Exact identifier application number: M022
Moon Platinum Advanced Whitening Anticavity	SODIUM FLUORIDE	Moon Oral Care LLC	ded3a5a6-2883-f3de-e053-2a95a90afb94	2026-01-09	Warnings	Exact identifier application number: M022
Moon Whitening Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0bdcad3e-b8e9-bd91-e063-6394a90a666a	2026-01-09	Warnings	Exact identifier application number: M022
Colgate Sensitive Prevent and Repair	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	e67410dc-a671-4611-8af1-097be071cd1c	2026-01-09	Warnings	Exact identifier application number: M022
Colgate Sensitive plus Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	2092c747-e025-47a9-9e54-731631d3c831	2026-01-09	Warnings	Exact identifier application number: M022
Dentemp Canker Cover	CANKER COVER	DOC Brands	2e7fbf9d-553c-c7bf-e063-6294a90a5f79	2026-01-08	Warnings	Exact identifier application number: M022
HyVee Throat Drops Lemon Mint	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	47e2650f-4f50-8d85-e063-6394a90a1ddc	2026-01-08	Warnings	Exact identifier application number: M022
Dentemp Canker Cover	CANKER COVER	DOC Brands	2b4b22e9-a03b-fb8f-e063-6394a90a8747	2026-01-08	Warnings	Exact identifier application number: M022
Crest 3D White Advanced	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	f3aa9a59-b4d4-05d9-e053-2995a90a0aea	2026-01-08		Exact identifier application number: M022
Oral B Plaque Defense Special Care Oral Rinse	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d503fad5-a378-0e60-e053-2a95a90abe65	2026-01-08	Warnings	Exact identifier application number: M022
Scope All Day CPC Antigingivitis/Antiplaque Mouthwash All Day	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d5f69341-b659-c74a-e053-2a95a90a317e	2026-01-08	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
858664	benzocaine 15 MG / menthol 2.6 MG Oral Lozenge	PSN	d771095b-7de3-48f3-a125-8bc76e7d1778	12
1235472	Cepacol Sore Throat 15 MG / 2.6 MG Oral Lozenge	PSN	d771095b-7de3-48f3-a125-8bc76e7d1778	12
1235472	benzocaine 15 MG / menthol 2.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]	SBD	d771095b-7de3-48f3-a125-8bc76e7d1778	12
858664	benzocaine 15 MG / menthol 2.6 MG Oral Lozenge	SCD	d771095b-7de3-48f3-a125-8bc76e7d1778	12
1235472	Cepacol Sore Throat Pain Relief 15/2.6 (benzocaine / menthol) Oral Lozenge	SY	d771095b-7de3-48f3-a125-8bc76e7d1778	12
1235472	Cepacol Sore Throat Pain Relief 15/2.6 Oral Lozenge	SY	d771095b-7de3-48f3-a125-8bc76e7d1778	12
858664	benzocaine 15 MG / menthol 2.6 MG Oral Lozenge	PSN	08160ced-e19b-443e-ab16-0d3e4ae8a8ab	7
1235472	Cepacol Sore Throat 15 MG / 2.6 MG Oral Lozenge	PSN	08160ced-e19b-443e-ab16-0d3e4ae8a8ab	7
1235472	benzocaine 15 MG / menthol 2.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]	SBD	08160ced-e19b-443e-ab16-0d3e4ae8a8ab	7
858664	benzocaine 15 MG / menthol 2.6 MG Oral Lozenge	SCD	08160ced-e19b-443e-ab16-0d3e4ae8a8ab	7
1235472	Cepacol Sore Throat Pain Relief 15/2.6 (benzocaine / menthol) Oral Lozenge	SY	08160ced-e19b-443e-ab16-0d3e4ae8a8ab	7
1235472	Cepacol Sore Throat Pain Relief 15/2.6 Oral Lozenge	SY	08160ced-e19b-443e-ab16-0d3e4ae8a8ab	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63824-732-16	63824073216	2 BLISTER PACK in 1 CARTON (63824-732-16) / 8 LOZENGE in 1 BLISTER PACK	2 blister pack	2013-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cēpacol ® Extra Strength* Sore Throat honey lemon	ATLANTIC BIOLOGICALS CORP.	2026-10-09	HUMAN OTC DRUG LABEL	9
Cēpacol ® Extra Strength Sore Throat honey lemon	Reckitt Benckiser LLC	2026-05-12	HUMAN OTC DRUG LABEL	12