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 5 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sensitivity Relief Fluoride Free	POTASSIUM NITRATE	Health and Natural Beauty USA Corp	c23b2a83-ebc3-4bcf-a216-7693944dcfa0	2026-05-22	Warnings	Exact identifier application number: M022
Sensitivity and Gum with Cavity Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Health and Natural Beauty USA Corp	137d6935-19a3-499d-957c-820156eec7a5	2026-05-22	Warnings	Exact identifier application number: M022
SEXYTEETH MINTY T00THPASTE	SEXYTEETH MINTY TOOTHPASTE	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	51d288c1-fe86-ffe1-e063-6394a90ab4c4	2026-05-14	Warnings	Exact identifier application number: M022
Cepacol Extra Strength Sore Throat cherry	BENZOCAINE AND MENTHOL	Reckitt Benckiser LLC	941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	2026-05-12	Warnings	Exact identifier application number: M022
Cepacol Extra Strength Sore Throat honey lemon	BENZOCAINE AND MENTHOL	Reckitt Benckiser LLC	d771095b-7de3-48f3-a125-8bc76e7d1778	2026-05-12	Warnings	Exact identifier application number: M022 ndc (product): 63824-732
SEXYTEETH CHARCOAL T00THPASTE	SEXYTEETH CHARCOAL TOOTHPASTE	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	51ab8a9a-6c12-b13b-e063-6294a90ace2a	2026-05-12	Warnings	Exact identifier application number: M022
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity	FLUORIDE	WHOLE FOODS	25bc7ab1-116d-143a-e063-6394a90aa970	2026-05-04	Warnings	Exact identifier application number: M022
Gingicaine Gel Strawberry	GINGICAINE GEL STRAWBERRY FLAVOR	Gingi-Pak a Division of the Belport	2fd37612-a28b-3aa1-e054-00144ff8d46c	2026-05-01	Warnings	Exact identifier application number: M022
3ECARE Dual formula WhiteningToothpaste Refill	SODIUM FLUORIDE	Hangzhou Namei Zhikang Technology Co., Ltd.	501df1c7-4884-bb39-e063-6294a90aaf6a	2026-04-23	Warnings	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	1f10a72f-0b49-41cb-92f9-b0160d7664de	2026-04-22	Warnings	Exact identifier application number: M022
EverSmile AlignerFresh Enamel Guard	SODIUM FLUORIDE	Everbrands, Inc.	7b3d0114-dac0-4370-8545-922ec018018e	2026-04-21	Warnings	Exact identifier application number: M022
PREOP	HYDROGEN PEROXIDE	Everbrands, Inc.	cc5cdd29-92c1-4ce0-997e-eb624b288b09	2026-04-20	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Cream	BENZOCAINE	CVS	a7576238-e7c8-7e86-e053-2995a90aaeb5	2026-04-20	Warnings	Exact identifier application number: M022
CVS Pharmacy Maximum Strength	BENZOCAINE	CVS Pharmacy	92747826-cf58-4406-b3b5-12f7c7077c2c	2026-04-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	9f991292-bbaa-4f4e-b2cb-059d1a04849e	2026-04-20	Warnings	Exact identifier application number: M022
Osstem S Sensitivity relief tooth	POTASSIUM NITRATE, SODIUM FLUORIDE	Osstem Pharma Co., Ltd	4f8ab179-8f29-a7cf-e063-6294a90a0c22	2026-04-15	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum DetoxifyWinter Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6db58f-0b09-d155-e063-6394a90ae658	2026-04-14	Warnings	Exact identifier application number: M022
Lolleez Orange Mango	PECTIN	BFY LLC	4f6dec8b-078a-f321-e063-6294a90a248c	2026-04-14	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum Restore Smooth Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6e3b36-e565-7d27-e063-6294a90ae5ac	2026-04-14	Warnings	Exact identifier application number: M022
Crest Pro-Health Nightly Bacteria Shield	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6ec1e0-c6b5-226f-e063-6294a90a8f14	2026-04-14	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